HOW A TRIPLE DRUG IS BETTER

1. 1
Addressing
challenges in
Asthma
management
Providing confidence
and simplicity

2. 2
Asthma is a chronic and burdensome inflammatory disease.
Patient behaviour, the need for early management and
current disparities between treatment recommendations
Challenges in
asthma management

3. 3
Why is asthma poorly controlled globally, even
when drugs like FB
& SF are available?

4. • Poor adherence to medication regimen
• Lack of understanding about asthma and how to manage it
• Exposure to triggers (e.g. smoking, pollution, allergens)
• Failure to recognize and respond to asthma symptoms
Patient related
factors
• Inappropriate or insufficient medication dosing
• Incorrect inhaler technique
• Adverse reactions or side effects to medication
• Inadequate access to medication or healthcare
• Co-existing medical conditions (e.g. obesity, GERD) that worsen asthma symptoms
• Chronic inflammation of the airways
• Genetic predisposition to severe asthma
• Environmental factors (e.g. climate, air pollution) that exacerbate asthma symptoms
• Failure to diagnose or properly classify asthma severity
• Inadequate patient education or counseling
• Inappropriate or delayed treatment interventions
• Lack of follow-up or monitoring of asthma control and symptoms.
•Drug/device
related factors
•Disease
related factors
•Physician
related factors

5. 5
Why do patients stop taking Asthma
medications (inhalers), when symptoms are
controlled?

6. 6
Impact of complicated
regimen
• Complicated regimens are hard to follow
• Decreased adherence is observed
• Patients tend to discontinue ICS-containing inhalers, creating
landscape for exacerbations
• Simplifying inhaler regimens by applying the same type of inhaler for
concomitant inhaled medications over time minimizes device misuse
• Patients using only less number of devices fare better
• Patients desire less number of devices to manage their disease
1. Palen, J. van der, J. J. Klein, CL van Herwaarden, G. A. Zielhuis, and E. R. Seydel. “Multiple Inhalers Confuse Asthma Patients.” European Respiratory Journal 14, no. 5 (November 1,
1999): 1034–37. https://doi.org/10.1183/09031936.99.14510349.
2. Schreiber, Jens, Tina Sonnenburg, and Eva Luecke. “Inhaler Devices in Asthma and COPD Patients - a Prospective Cross-Sectional Study on Inhaler Preferences and Error Rates.” BMC
Pulmonary Medicine 20, no. 1 (August 20, 2020): 222. https://doi.org/10.1186/s12890-020-01246-z.
3. Usmani, Omar S., Anthony J. Hickey, Deniz Guranlioglu, Kacey Rawson, Neda Stjepanovic, Shahid Siddiqui, and Rajiv Dhand. “The Impact of Inhaler Device Regimen in Patients with
Asthma or COPD.” The Journal of Allergy and Clinical Immunology. In Practice 9, no. 8 (August 2021): 3033-3040.e1. https://doi.org/10.1016/j.jaip.2021.04.024.

7. 7
What are the major reasons patients stop taking
asthma medications when symptoms are
controlled?

8. 8
Non-adherence
causes
patient-related
factors
inadequate
knowledge
Types
Accidental
unaware of non-
compliance
Intentional non-
adherence
conscious non-
compliance
J Asthma. 2006;43:701–714.
Both types of non-adherence can be present in the same individual.

9. 9
What are the implications of not
taking asthma medications
(inhalers) when symptoms are
controlled?

10. 10
• Asthma symptoms may return or worsen
• Increased risk of asthma attacks or exacerbations
• Reduced lung function and breathing capacity over time
• Increased need for rescue medications such as Salbutamol
• Increased doses required to regain control
• Reduced quality of life due to asthma symptoms and limitations on
daily activities
• Onset of structural lung changes
• Higher overall costs

11. 11
Is regular dosing important?
What has better outcomes in
asthma management – PRN or
PRD & why?

12. 12
Asthma is a chronic and burdensome
inflammatory disease
QALY, quality-adjusted life year.
1. GINA 2022. Available from: https://ginasthma.org/gina-reports/. Accessed 07 November 2022; 2. WHO. https://www.who.int/news-room/fact-sheets/detail/asthma. Accessed 07 November 2022;
3. Yaghoubiet M, et al. Am J Respir Crit Care Med 2019;200:1102–12.
Asthma
…
…is a heterogeneous disease usually characterised by chronic airway inflammation1
…is defined by the history of respiratory symptoms such as wheeze, shortness of
breath, chest tightness and cough that vary over time and in intensity together with
variable
airflow limitation1
…affects an estimated
262 million
people worldwide2
…is associated with
461,000
deaths per year2

13. 13
The obstacles to optimal asthma management
are multifaceted
HCP, healthcare professional; ICS, inhaled corticosteroid.
1. Amini M, et al. BMC Public Health 2021;21:401; 2. Pearson-Stuttard J, et al. Lancet Diabetes Endocrinol 2021;9:165–73; 3. Ebmeir S, et al. Lancet 2017;390:935–45; 4. GINA 2022. Available from: https://ginasthma.org/gina-reports/.
Accessed 10 November 2022; 5. Price D, et al. NPJ Prim Care Respir Med 2014;24:14009; 6. Blakeston S, et al. J Asthma 2020; doi: 10.1080/02770903.2020.1761382; 7. Agertoft L, Pedersen S. Respir Med 1994;88:373−81.
• Despite its challenges, regular ICS dosing is the cornerstone of asthma treatment and should be the standard aim in
patients for whom good adherence is possible4
• The decline in asthma-related mortality rates has slowed in recent years, compared with other chronic diseases1–3
• Suboptimal asthma management can happen at multiple points in the patient journey4–7
Disease factors Physician factors
Patient factors
Symptoms in mild-
moderate asthma are often
infrequent4
HCPs need to optimise
early diagnosis and
management of asthma
patients to improve
outcomes7
Treatment
recommendations are
shifting,4 leading to HCP
confusion over best practice
Healthcare factors
Patient perceptions of
asthma control are often
poor, which can lead to
undertreatment with ICS5
Patients may develop
overreliance on reliever
therapies to immediately
treat symptoms6

14. 14
HCPs need to optimise early diagnosis and
management of asthma patients to improve outcomes
In a survey of primary care/internal medicine
physicians, only:2
37% issue written action plans
10% use validated asthma control questionnaires
57% estimated medication use by objective means
Mild
intermittent
(28%)
Mild
persistent
(19%)
Moderate
persistent
(28%)
Severe
persistent
(25%)
Over half of previously undiagnosed asthma patients
have moderate or severe disease at time of diagnosis*1
HCP, healthcare professional.
*Cross-sectional study of 249 patients with undiagnosed asthma identified by an asthma screening survey mailed to 10,877 randomly selected individuals aged 18–44 years in Denmark.
This graph has been independently created by GSK from the original data published in Backer V, et al. Int J Tuberc Lung Dis 2007;11:463–9.
1. Backer V, et al. Int J Tuberc Lung Dis 2007;11:463–9; 2. Chapman K, et al. BMC Pulm Med 2017;17:153.

15. 15
Achieving good treatment adherence is the main
challenge for optimal asthma management
ICS, inhaled corticosteroid; SABA, short-acting β2-agonist
1. Bårnes CB, Ulrik CS. Respir Care 2015;60:455-68; 2. Amin S, et al. Patient Prefer Adherence 2020:541-51; 3. Bidad N, et al. Eur Respir J 2018;51:1701346; 4. Barnes PJ, et al. J Allergy Clin Immunol 2019;144:1180–6.
While regular ICS use is the cornerstone of effective
maintenance therapy, many patients prescribed ICS
treatment continue to have uncontrolled asthma,
attributable to poor adherence1
A review of five real-world studies reported that in adults,
ICS is only taken as prescribed 22–63% of the time1
Finding out why a patient does not adhere to their
prescribed treatment is important to identify the best
ICS regimen and educational needs for them1–3
Common factors
driving poor
adherence to
regular ICS in
asthma
Asymptomatic
periods2
Poor perception
of asthma
control4
Lack of
communication
with healthcare
providers1
Misconceptions
about asthma
medications2,3
Steroid phobia2,3
Overuse of
SABA reliever
therapy2

16. 16
Patient and physician
perspectives on
asthma management
Perceptions of asthma control and treatment are
impacting management
Physician-patient communication is vital to optimise
treatment plans

17. 17
Misconceptions around asthma control and
medications may impact treatment adherence
GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid.
1. Magadle R, et al. Chest. 2002 Feb;121(2):329–33; 2. Price D, et al. NPJ Prim Care Respir Med 2014;24:14009; 3. Chapman KR, et al. Respir Med 2022; doi: 10.1016/j.rmed.2022.106948.
26% of all stable asthma patients underperceive their asthma
symptoms, which may lead to undertreatment1
<10% of patients consider their asthma to be
not controlled or poorly controlled…
However, >50% report frequent symptoms,
suggesting they do not have well-controlled asthma3
Of the patients who consider their asthma
to be controlled…
83.7% are uncontrolled
according to GINA definitions2
Over 80% have experienced ≥1 acute
exacerbation in the previous 12 months2

18. 18
Patient education is needed to dissipate
asthma medication myths
HCP, healthcare professional; ICS, inhaled corticosteroid.
Bidad N, et al. Eur Respir J 2018;51:1701346.
Myth Driver
‘Preventer’ (ICS) medications are to be
used to prevent acute symptom worsening
A belief that medications are only needed when
symptoms are apparent
Steroid-phobia: the belief that chronic use of
steroids, even inhaled corticosteroids, are
associated with significant side effects
Misconceptions over the safety of ICSs, and the
belief that they will have significant systemic effects
Bronchodilators are more potent
than ICSs
Patients feel an immediate benefit from reliever
bronchodilators and therefore mistakenly assume that
they are more effective than controller medications
Chronic medications are not needed to
treat asthma
A belief that as they have a low symptom burden for a
large proportion of time, inconvenient chronic treatments
are not needed

19. 19
<10% of patients say their asthma is not
controlled or poorly controlled; however,
>50% report frequent symptoms,
suggesting they do not have well-controlled
asthma
Patients’ perception of asthma control is often
poor, and this may lead to undertreatment
This graph has been independently created by GSK from the original data published in Chapman KR, et al. Respir Med 2022; doi: 10.1016/j.rmed.2022.106948.
APPaRENT 2, a multinational,
cross-sectional online survey
conducted August–November
2021, gathered opinions from
1,650 patients from Argentina,
Brazil, France, Italy and Mexico
34%
60%
6%
0
42%
31%
14%
18%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Mild Moderate Severe Severity unclear
or fluctuating
Proportion
of
patients,
%
Patient assessment Physician assessment
Perception of asthma control

20. 20
Regular treatment of airway inflammation is key
The evidence for regular ICS in mild asthma
The evidence for regular ICS/LABA in moderate asthma
The science
of PRD
PRD, Proactive regular dosing

21. 21
Asthma symptoms are the tip of the iceberg1
Achieving asthma control means controlling the underlying inflammation
ICS, inhaled corticosteroid; prn, as-needed; SABA, short-acting ß2-agonist.
1. Palomares O, et al. Int J Mol Sci 2017;18:1328; 2. GINA 2022. Available from: https://ginasthma.org/gina-reports/. Accessed 04 November 2022; 3. Martin MJ, Harrison T. Eur Respir J 2019;53:1802223; 4. Bousquet J, et al. Am J Respir Crit
Care Med 2000;161:1720–45; 5. Busse W. Chest 2010;138(2 Suppl):4S–10S; 6. Ozier A, et al. J Allergy 2011;742710; 7. Sont JK, et al. Am J Respir Crit Care Med 1999;159:1043–51; 8. Ward C, et al. Thorax 2002:57:309–16; 9. Boushey H, et
al. N Engl J Med 2005;352:1519–28; 10. Chauhan BF, et al. Cochrane Database Syst Rev 2013;28(2):CD009611; 11. Rodrigo GJ, et al. Respir Med 2013;107:1133–40; 12. Turpeinen M, et al. Arch Dis Child 2008;93:654–9.
Lung function
Bronchial hyper-
responsiveness
Airway
inflammation
Airway
remodelling
Invisible
outcomes2
Exacerbations
Symptoms Visible
outcomes2
ICS acts here...
Important role but
effects are not visible4–8
Increased SABA use
for worsening asthma
symptoms may lead to
symptom relief but
does not suppress
airway inflammation3
Regular ICS-based treatment
+ SABA prn is proven to:9–12
• Control symptoms
• Reduce inflammation
• Reduce airway remodelling
• Reduce exacerbations and
asthma-related hospitalisations
The anti-inflammatory
protective effect of
ICS treatment builds up
over time; therefore, to get
the most benefit, it should
be taken regularly8

22. 22
• *PRN defined as infrequent or as-needed use (dosing 3-4 times per week)
Horizontal dotted lines indicate thresholds for no treatment-related bronchoprotective effect and clinically significant bronchoprotective effect defined as an AMP PC20 < 16 mg/mL (<
0.25 DD difference from placebo), and an AMP PC20 ≥ 27 mg/ml (≥ 1.0 DD difference from placebo), respectively
• AMP, adenosine-5'-monophosphate; BID, twice daily; BUD, budesonide; DD, doubling dose; Form, formoterol; FP, fluticasone propionate; ICS, inhaled corticosteroids; PRD, proactive
regular dosing; PRD, proactive regular dosing; PRN, as needed.
FP PRD provides a clinically significant bronchoprotective effect for 99.9% of time
vs. 26% of the time with BUD PRN*
Reprinted by permission from Springer Nature. Daley-Yates P, et al. Adv Ther 2021; Dec 7. https://doi.org/10.1007/s12325-021-01976-4. Epub ahead of print.
Pharmacology Versus Convenience: A Benefit/Risk Analysis of Regular Maintenance Versus Infrequent or As-Needed Inhaled Corticosteroid Use in Mild Asthma.
Copyright © 2021, Springer Nature Limited.
Bronchoprotection,
PC20,
DD
Hours
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30
512
256
128
64
32
16
8
FP 200 µg/bid PRD (100% adherence) BUD 200 µg PRN (dosing 3-4 times per week)*
Bronchoprotection,
PC20
Hours
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30
512
256
128
64
32
16
8
Analysis of regular maintenance v/s infrequent or
as-needed inhaled corticosteroid use in mild asthma

23. 23
PRD is the most effective ICS dosing regimen to improve
asthma control and prevent exacerbations in mild asthma
*3-year, randomised, double-blind study (n with mild asthma =7165; aged 5–66 years) designed to compare the effects of BUD 400 µg qd (200 µg qd aged ≤11 years)
(n=3597) with placebo qd (n=3568) on lung function and exacerbations. Both treatments were well tolerated.
BUD, budesonide; FeNO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in one second; ICS, inhaled corticosteroid; qd, once daily; PRD, proactive regular dosing.
These graphs have been independently created by GSK from the original data published in the source references.
1. Boushey H, et al. N Engl J Med 2005;352:1519–28; 2. Pauwels RA, et al. Lancet 2003;361:1071–6.
Daily ICS Intermittent dosing
-0.4
-0.3
-0.6
-0.5
-0.4
-0.3
-0.2
-0.1
0
Change
in
asthma
control
score
from
…
Asthma control1
Improved
control
-14.4
26.6
-20
-10
0
10
20
30
Average
change
in
exhaled
nitric
oxide
in
…
FeNO1
Less
inflammation
Regular ICS supports greater improvements in asthma control and markers of inflammation than
intermittent dosing and also prevents exacerbations1,2
0.4 0.6 0.8 1 1.2 1.4 1.6
Hazard ratio
(Daily ICS vs placebo; time to first severe exacerbation)
Favours placebo
Favours daily ICS
44% reduction in risk of a first exacerbation
event with daily ICS vs placebo2
Risk of first severe exacerbation2,*

24. 24
Regular ICS is non-inferior to symptom-driven dosing
in reducing the rate of exacerbations
0.4 0.6 0.8 1 1.2 1.4 1.6 1.8
Favours regular
BUD
Favours prn
BUD/FOR
Rate ratio
(prn BUD/FOR vs regular BUD)
Severe
exacerbations
p=0.75
SYGMA 21
SYGMA 1 was a double-blind, randomised, parallel group, 52-week, Phase III trial that evaluated the efficacy and safety of BUD/FOR (200/6 mcg prn; n=1277), vs terbutaline (0.5 mg prn; n=1277) or twice-daily BUD (200 μg bid; n=1282) +
terbutaline (0.5 mg prn) in patients aged ≥12 years with GINA Step 2 asthma. SYGMA 2 was a double-blind, randomised, international, parallel-group, 52-week, Phase III trial that evaluated the efficacy and safety of BUD/FOR (200/6 mcg prn;
n=2089) vs twice-daily BUD (200 μg bid; n=2087) + terbutaline (0.5 mg prn) in patients aged ≥12 years with GINA Step 2 asthma. NovelSTART was a 52-week, randomised, open-label, parallel group, controlled trial that evaluated the safety and
efficacy of albuterol prn (n=223), budesonide + albuterol prn (n=225) or BUD/FOR prn (n=220) in patients aged ≥18 years with GINA Step 2 asthma.
BUD, budesonide; FOR, formoterol; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid; prn, as-needed.
These graphs have been independently created by GSK from the original data published in the source references.
1. Bateman ED, et al. N Engl J Med 2018;378:1877–87; 2. Beasley R, et al. N Engl J Med 2019;380:2020–30; 3. O’Byrne PM, et al. N Engl J Med 2018;378:1865–76.
0.4 0.6 0.8 1 1.2 1.4 1.6 1.8
Favours regular
BUD
Favours prn
BUD/FOR
Rate ratio
(prn BUD/FOR vs regular BUD)
Total
exacerbations p=0.65
NovelSTART2
0.4 0.6 0.8 1 1.2 1.4 1.6 1.8
Favours regular
BUD
Favours prn
BUD/FOR
Rate ratio
(prn BUD/FOR vs regular BUD)
Severe
exacerbations
p=0.28
SYGMA 13
Mod/Sev
exacerbations
p=0.66

25. 25
In patients receiving ICS, PRD supports greater
symptom control than symptom-driven dosing
SYGMA 11
-0.46
-0.35
-0.5
-0.4
-0.3
-0.2
-0.1
0
Change
in
ACQ-5
score
from
baseline
SYGMA 22
-0.4 -0.2 0 0.2 0.4
NovelSTART3
Mean difference at all timepoints between
prn BUD/FOR and regular BUD + SABA
Favours regular BUD
Favours prn BUD/FOR
SYGMA 1 was a double-blind, randomised, parallel group, 52-week, Phase III trial that evaluated the efficacy and safety of BUD/FOR (200/6 mcg prn; n=1277), vs terbutaline (0.5 mg prn; n=1277) or twice-daily BUD (200 μg bid; n=1282) +
terbutaline (0.5 mg prn) in patients aged ≥12 years with GINA Step 2 asthma. SYGMA 2 was a double-blind, randomised, international, parallel-group, 52-week, Phase III trial that evaluated the efficacy and safety of BUD/FOR (200/6 mcg prn;
n=2089) vs twice-daily BUD (200 μg bid; n=2087) + terbutaline (0.5 mg prn) in patients aged ≥12 years with GINA Step 2 asthma. NovelSTART was a 52-week, randomised, open-label, parallel group, controlled trial that evaluated the safety and
efficacy of albuterol prn (n=223), BUD + albuterol prn (n=225) or BUD/FOR prn (n=220) in patients aged ≥18 years with GINA Step 2 asthma. PRACTICAL was an investigator-led, pragmatic, 52-week, open-label, parallel-group, multicentre,
superiority, randomised controlled trial that assessed the real-world safety and efficacy of BUD/FOR (200/6 mcg prn; n=437) or BUD (200 mcg bid; n=448) + terbutaline prn in asthma patients aged 18–75 years who use SABA prn alone of low-
dose daily ICS/LABA + SABA prn.
ACQ, Asthma Control Questionnaire; BUD, budesonide; FOR, formoterol; ICS, inhaled corticosteroid; PRD, proactive regular dosing; prn, as-needed; SABA, short-acting 2-agonist.
These charts have been independently created by GSK from the original data published in the source references.
1. O’Byrne PM, et al. N Engl J Med 2018;378:1865–76; 2. Bateman ED, et al. N Engl J Med 2018;378:1877–87; 3. Beasley R, et al. N Engl J Med 2019;380:2020–30; 4. Hardy J, et al. Lancet 2019;394:919–28.
-0.4 -0.2 0 0.2 0.4
PRACTICAL4
Favours regular BUD
Favours prn BUD/FOR
Mean difference at all timepoints between
prn BUD/FOR and regular BUD + SABA
-0.48
-0.33
-0.5
-0.4
-0.3
-0.2
-0.1
0
Change
in
ACQ-5
score
from
baseline

26. 26
PRD gives a higher ICS airway efficacy than MART
BID, twice daily; BUD, budesonide; DD, doubling dose; FOR, formoterol; FP, fluticasone propionate; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; MART, maintenance and reliever therapy;
PRD, proactive regular dosing; PRN, as-needed; QD, once daily; SAL, salmeterol.
This graph has been independently created by GSK from the original data published in Singh D, et al. Adv Ther 2022; doi: 10.1007/s12325-022-02092-7.
In moderate asthma,
ICS/LABA PRD regimens
have higher airway
efficacy and similarly low
systemic activity,
compared with MART
PRD with ≥85% adherence
in moderate asthma gives
the
optimal ICS benefit-risk
ratio
KEY
Simulation: ICS/LABA
BID maintenance
(% adherence)
Clinical trial: MART BID
maintenance + PRN
dosing
Clinical trial: MART BID
(x2) maintenance + PRN
dosing
Clinical trial: MART QD
maintenance + PRN
dosing
Comparison of airway efficacy to systemic activity for
BUD/FOR MART and regular ICS/LABA dosing regimens in
moderate asthma
Duration of clinically significant bronchoprotection ≥1.5 DD during 28 days, %
High airway efficacy/
low systemic activity
Low airway efficacy/
low systemic activity
BUD/FOR 800 mcg (100%)
BUD/FOR 800 mcg (85%)
BUD/FOR 400 mcg (85%)
BUD/FOR 100/6 mcg
Low airway efficacy/
high systemic activity
BUD/FOR 400 mcg (100%)
Average
daily
cortisol
suppression
during
28
days,
%
Optimal benefit-risk ratio
BUD/FOR 200/6
mcg
BUD/FOR 200/6
mcg BUD/FOR 200/6
mcg
FP/SAL 500 mcg (100%)
High systemic
activity
High airway efficacy
0
10
20
30
40
50
50 60 70 80 90 100
High airway efficacy/high systemic
activity
FP/SAL 250 mcg (100%)
FP/SAL 250 mcg (85%)
FP/SAL 500 mcg
(85%)
BUD/FOR 200/6 mcg
BUD/FOR 200/6 mcg
BUD/FOR 200/6 mcg
BUD/FOR 200/6 mcg
BUD/FOR 200/6 mcg

27. 27
Regular ICS outperforms symptom-driven
dosing in lung function improvement
-0.1 -0.05 0 0.05 0.1
Mean difference in FEV1 at all timepoints between
prn BUD/FOR and regular BUD + SABA
Favours regular BUD
Favours prn BUD/FOR
136.6
104.0
0
20
40
60
80
100
120
140
160
Change
in
prebronchodilator
FEV
1
from
baseline
(mL)
p=0.003
p<0.001
SYGMA 1 was a double-blind, randomised, parallel group, 52-week, Phase III trial that evaluated the efficacy and safety of BUD/FOR (200/6 mcg prn; n=1277), vs terbutaline (0.5 mg prn; n=1277) or twice-daily BUD (200 μg bid; n=1282) +
terbutaline (0.5 mg prn) in patients aged ≥12 years with GINA Step 2 asthma. SYGMA 2 was a double-blind, randomised, international, parallel-group, 52-week, Phase III trial that evaluated the efficacy and safety of BUD/FOR (200/6 mcg prn;
n=2089) vs twice-daily BUD (200 μg bid; n=2087) + terbutaline (0.5 mg prn) in patients aged ≥12 years with GINA Step 2 asthma. NovelSTART was a 52-week, randomised, open-label, parallel group, controlled trial that evaluated the safety and
efficacy of albuterol prn (n=223), BUD + albuterol prn (n=225) or BUD/FOR prn (n=220) in patients aged ≥18 years with GINA Step 2 asthma. PRACTICAL was an investigator-led, pragmatic, 52-week, open-label, parallel-group, multicentre,
superiority, randomised controlled trial that assessed the real-world safety and efficacy of BUD/FOR (200/6 mcg prn; n=437) or BUD (200 mcg bid; n=448) + terbutaline prn in asthma patients aged 18–75 years who use SABA prn alone of low-
dose daily ICS/LABA + SABA prn.
BUD, budesonide; FEV1, forced expiratory volume in one second; FOR, formoterol; ICS, inhaled corticosteroid; prn, as-needed; SABA, short-acting 2-agonist.
These charts have been independently created by GSK from the original data published in the source references.
1. O’Byrne PM, et al. N Engl J Med 2018;378:1865–76; 2. Bateman ED, et al. N Engl J Med 2018;378:1877–87; 3. Beasley R, et al. N Engl J Med 2019;380:2020–30; 4. Hardy J, et al. Lancet 2019;394:919–28.
SYGMA 11 SYGMA 22
-0.1 -0.05 0 0.05 0.1
Mean difference in FEV1 at all timepoints between
prn BUD/FOR and regular BUD + SABA
Favours regular BUD
Favours prn BUD/FOR
119.3
65.0
0
20
40
60
80
100
120
140
160
Change
in
prebronchodilator
FEV
1
from
baseline
(mL)
Regular ICS Symptom-
driven
Regular ICS Symptom-
driven
PRACTICAL4
NovelSTART3

28. 28
12
Well controlled on
prior ICS therapy
2
Regular ICS/LABA reduces exacerbation risk
vs ICS alone for many patients
AUSTRI*1 GOAL†2
*This was a prospective, multicentre, randomised, double-blind trial to assess the safety and efficacy of FP/SAL (100/50; 250/50 or 500/50 mcg bid) vs FP alone (50 mcg bid) in 11,679 patients with ≥1 year of asthma history;
†This was a 1-year, stratified, randomised, double-blind, parallel-group study comparing the efficacy of FP/SAL (n=1,709) or FP alone (n=1,707) in achieving asthma control in patients aged 12–80 with ≥6 months history of asthma and an improvement
in FEV1 of ≥15% to SABA. Asthma control was defined as per GINA/NIH guidelines.
CI, confidence interval; FP, fluticasone propionate; GINA, Global Initiative for Asthma; HR, hazard ratio; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; NIH, National Institutes of Health; S1/2/3, stratum 1/2/3; SABA, short-acting β2-agonist;
SAL, salmeterol.
These graphs have been independently created by GSK from the original data published in the source references.
1. Stempel DA, et al. N Engl J Med 2016;374:1822–30; 2. Bateman ED, et al. Am J Respir Crit Care Med 2004;170:836–44.
14
10
8
6
4
0
Not well controlled on
prior ICS or non-LABA therapy
Not well controlled on prior
ICS+LABA therapy
8
6
12
10
9
11
6
9
HR 0.83
95% CI (0.63, 1.10)
p=0.20
HR 0.84
95% CI (0.65, 1.09)
p=0.19
HR 0.79
95% CI (0.65, 0.91)
p=0.002 HR 0.68
95% CI (0.45, 1.03)
p=0.07
FP (n=5845)
FP/SAL (n=5834)
Not well controlled
on prior ICS+LABA therapy
0
0.1
0.4
0.12
0.05
0.16
0.13
0.37
0.28
0.2
0.3
Steroid-naïve (S1) Low-dose ICS (S2) Moderate-dose ICS (S3)
FP (n=1,707)
FP/SAL (n=1,709)
Mean
exacerbations
per
patient
per
year
Proportion
of
patients
experiencing
a
severe
exacerbation
(%)

29. 29
In patients receiving ICS/LABA, PRD supports greater
reductions in airway inflammation than MART
-60
-40
-20
0
20
40
60
Change
from
baseline
(%)
Eosinophils in induced sputum2
p<0.0038
-60
-40
-20
0
20
40
60
80
100
Change
from
baseline
(%)
Endobronchial biopsies2
Mast cells
p=0.0012
Eosinophils
p<0.001
Less
inflammation
Regular maintenance
dosing
Maintenance and
reliever regimen
Time to first exacerbation is not significantly reduced by
ICS symptom-driven dosing vs regular dosing1,2
52-week, parallel-group, randomised, double-blind study (n with asthma=127;18–65 years) designed to compare the effects of BUD/FOR 200/6 µg bid plus as-needed (n=64) with BUD/FOR 800/12 µg bid (n=63) on airway
eosinophils and remodelling. Both treatments were well tolerated.
bid, twice daily; BUD/FOR, budesonide/formoterol; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; MART, maintenance and reliever therapy.
These graphs have been independently created by GSK from the original data published in Pavord I, et al. J Allergy Clin Immunol 2009;123(5):1083–9.
1. Bousquet J, et al. Respir Med 2007;101:2437–44; 2. Pavord I, et al. J Allergy Clin Immunol 2009;123(5):1083–9.

30. 30
Appropriate ICS use (ratio of ICS to total asthma
medications >0.5) is strongly associated with a
lower risk of inappropriate or excessive SABA
use in
the next year compared with inappropriate ICS use3,*
Adequate ICS therapy prevents excessive SABA use
across all asthma severities
0.1
(0.10–0.11) 0.09
(0.09–0.10)
0
0.05
0.1
0.15
Inappropriate SABA use Excessive SABA use
Odds
ratio
(95%
Cl)
Appropriate use of ICS
p<0.0001
*Canadian health data (1997–2014; n=343,520 [56.3% female, average age 30.5 years]) was used to create a retrospective cohort of patients with asthma. The primary and secondary outcomes were, respectively, inappropriate and excessive
use of SABA based on a previously validated definition. 7.3% of person-years were categorised as inappropriate SABA use and 0.9% as excessive use. ‘Inappropriate use’ if either of the following conditions was satisfied: 1-no use of ICS with 2
or more puffs of SABA per week, or 2-use of more than 9 canisters of SABA during the year and no more than 100 μg/day of ICS. Excessive use of SABA was defined as filling prescriptions for >12 canisters of SABA during the year.
BHR, bronchial hyperreactivity; CI, confidence interval; ICS, inhaled corticosteroid; PRD, proactive regular dosing; SABA, short-acting β2-agonist.
These graphs have been independently created by GSK from the original data published in the source references.
1. Sont JK, et al. Am J Respir Crit Care Med 1999;159:1043–51; 2. Bateman ED, et al. Am J Respir Crit Care Med 2004;170:836–44; 3. Tavakoli H, et al. BMC Pulm Med 2018;18:33.
ICS PRD promotes appropriate SABA use because it
manages the underlying inflammation to improve
asthma control and thereby reduce the need for
symptom relief1,2
SABA
use
NO ICS INCREASING ICS OPTIMAL ICS
DECREASING SABA USE
DECREASING INFLAMMATION/BHR
p<0.0001

31. 31
ICS/LABA PRD significantly improves HRQoL in
adults with moderate-severe asthma
Random-effects
mean difference
(95% CI)
Probability that
FP/SAL is better
than comparator
FP/SAL vs Placebo 0.65 (0.54, 0.78) 100%
FP/SAL vs LABA 0.58 (0.33, 0.84) 100%
FP/SAL vs ICS 0.21 (0.13, 0.31) 100%
FP/SAL vs other
ICS/LABA
0.06 (-0.04,
0.19)
88.3%
FP/SAL vs ICS/FOR
MART
0.00 (-0.13,
0.14)
49.9%
-2 0 1 2
-1
Favours FP/SAL
Favours comparator
*Number of patients in each treatment group: FP/SAL, 4,914; Placebo, 950; LABA, 682; ICS, 4,637; Other ICS/LABA, 5,066; MART, 2,370.
AQLQ, Asthma Quality of Life Questionnaire; CI, confidence interval; FOR, formoterol; FP, fluticasone propionate; HRQoL, health-related quality of life; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; MART, maintenance and
reliever therapy;
PRD, proactive regular dosing; SAL, salmeterol.
This graph has been independently created by GSK from the original data published in Maneechotesuwan K, et al. Resp Med 2022: doi 10.1016/j.rmed.2022.106993.
Reducing asthma symptoms and
exacerbations is key to improve HRQoL
Base case results showing difference in mean change from
baseline in AQLQ for FP/SAL vs other interventions
This network analysis included a total of 15 studies and >18,000 patients*
A network meta-analysis of articles
published 2001–2021 compared HRQoL
improvements from baseline (assessed
through the AQLQ)
 Asthma control with twice daily FP/SAL is
strongly associated with HRQoL improvement
 Improvement of HRQoL with FP/SAL is
comparable with other ICS/LABA and ICS/FOR
MART regimens

32. 32
ICS PRD is associated with lower rates of discontinuation
vs MART ICS/LABA
Outcome Maintenance and
reliever therapy
(n/N)
Regular
maintenance
dosing (n/N)
Odds ratio
(95% CI)
P-value for
overall effect
Heterogeneit
y
Patients with
exacerbations
requiring oral
steroids
257/4433
5.8%
304/4408
6.9%
0.83
[0.70, 0.98]
Z=2.18;
p=0.029
I2=0%
Patients with
exacerbations
requiring
hospitalisation
21/4433
0.5%
26/4408
0.6%
0.81
[0.45, 1.44]
Z=0.72;
p=0.47
I2=0%
Discontinuation
due to adverse
events
88/4224
2.1%
31/4187
0.7%
2.85
[1.89, 4.30]
Z=4.98;
p=0.00001
I2=0%
1.0 3.0 10.0
0.3
0.1
The aim of this Cochrane analysis was to assess the efficacy and safety of BUD/FOR as MART vs ICS maintenance treatment (alone or as part of current best practice) and any reliever therapy. Included 13 trials of at least 12 weeks
duration involving 13,152 adults; one of the trials also involved 224 children (which have been separately reported).
CI, confidence interval; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; MART, maintenance and reliever therapy; PRD, proactive regular dosing.
This graph has been independently created by GSK from the original data published in Cates C, et al. Cochrane Database Syst Rev 2013;Issue 4:CD007313.
Odds ratio
(MART ICS/LABA vs PRD ICS)

33. 33
Seventy percent of patients treated with ICS/LABA
PRD achieve partial or total asthma control
AE, adverse event; FP, fluticasone propionate; ICS, inhaled corticosteroid; LABA, long-acting β2-agonist; PRD, proactive regular dosing; SAL, salmeterol.
*Totally controlled asthma was achieved if the patient, during the 8 consecutive assessment weeks, recorded 7 totally controlled weeks and had no exacerbations, emergency room criteria, or medication-related adverse event criteria for
each day of each week. Well-controlled asthma was achieved if the patient recorded 7 of 8 well-controlled weeks, and failure to achieve any one of these would result in failure to achieve control for that week.
Partial control = Well-controlled (71%) – Total control (42%) = 29%.
1. Bateman E, et al. Eur Respir J 2007;29(1):56–63; 2. Bateman ED, et al. Am J Respir Crit Care Med 2004;170:836–44.
Not
controlled
Partial
control
Total
control*
1-year, randomized, stratified, double-
blind, parallel-group study (n>3,000) in
patients with uncontrolled asthma
compared
FP vs FP/SAL in achieving totally
and well-controlled asthma.
Treatment was stepped-up until total
control was achieved (or maximum 500
µg corticosteroid twice a day).
29% 29% 42%
After 1 year of PRD1,2

34. 34
GINA recommends PRD in patients who are adherent
to treatment
Global and national guidelines agree on the
importance of regular ICS use
Where PRD stands
in current treatment
recommendations

35. 35
GINA recommends PRD-based dosing regimens for the
treatment of patients who are adherent to asthma therapy
Intermittent
(Step 1/2) and
regular dosing
(3–5) regimens
(prn or MART)
Regular
dosing
regimens
(PRD)
STARTING TREATMENT
in adults and adolescents with a diagnosis of asthma
Track 1 is preferred if the patient is likely to be poorly adherent with daily controller
ICS-containing therapy is recommended even if symptoms are infrequent, as it
reduces the risk of severe exacerbations and need for OCS.
• Confirm diagnosis
• Symptom control
and modifiable risk
factors, including
lung function
• Comorbidities
• Inhaler technique
and adherence
• Patient preferences
and goals
CONTROLLER and
PREFERRED RELIEVER
(Track 1). Using ICS-formoterol
as reliever reduces the risk of
exacerbations compared with
using a SABA reliever
CONTROLLER
and ALTERNATIVE
RELIEVER
(Track 2). Before considering
a regimen with SABA reliever,
check if the patient is likely
to be adherent with daily
controller therapy
START
HERE IF:
START
HERE IF:
FIRST
ASSESS:
Symptoms less than
4–5 days a week
Symptoms most days,
or waking with asthma
once a week or more
Daily symptoms,
or waking with asthma
once a week or more,
and low lung function
STEPS 1–2
As-needed low dose ICS-formoterol
RELIEVER: As-needed low dose ICS-formoterol
STEP 3
Low dose
maintenance
ICS-formoterol
STEP 4
Medium dose
maintenance
ICS-formoterol
STEP 5
Add-on LAMA
Refer for phenotypic
assessment ± anti-IgE,
anti-IL5/5R, anti-IL4R
Consider high dose
ICS-formoterol
Symptoms less than
twice a month
Symptoms most days,
or waking with asthma
once a week or more
Daily symptoms, or
waking with asthma
once a week or more,
and low lung function
STEP 1
Take ICS whenever
SABA taken
RELIEVER: As-needed short-acting β2-agonist
STEP 3
Low dose
maintenance
ICS-LABA
STEP 4
Medium/high
dose maintenance
ICS-LABA
STEP 5
Add-on LAMA
Refer for phenotypic
assessment ± anti-IgE,
anti-IL5/5R, anti-IL4R
Consider high dose
ICS-LABA
Symptoms twice a
month or more, but
less than 4–5 days
a week
STEP 2
Low dose
maintenance ICS
GINA, Global Initiative for Asthma; HCP, healthcare professional; ICS, inhaled corticosteroid; Ig, immunoglobulin; IL, interleukin; LABA, long-acting β2-agonist; LTRA, leukotriene receptor antagonist; MART, maintenance and
reliever therapy; OCS, oral corticosteroid; PRD, proactive regular dosing; prn, as-needed; SABA, short-acting β2-agonist.
GINA 2022. Available from: https://ginasthma.org/gina-reports/. Accessed 07 November 2022.
Short course OCS
may also be needed
for patient presenting
with severely
uncontrolled asthma
Short course OCS
may also be needed
for patient presenting
with severely
uncontrolled asthma

36. 36
The place of PRD in asthma treatment
recommendations is evolving
• This change represents an acceptance of patient behaviour1–3
• As some patients are unable to maintain adequate adherence to regular ICS treatment, symptom-
driven
ICS dosing is rationalised as ensuring at least some ICS is received at the time of an exacerbation1–4
• GINA recommendations do not indicate that MART regimens are more effective than PRD
for asthma management1
GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid; MART, maintenance and reliever therapy; PRD, proactive regular dosing; SABA, short-acting β2-agonist.
See slide notes for references.
GINA now recommends ICS/FOR as-needed at Steps 1 & 2, and MART at Step 3, as an alternative
to ICS PRD plus as-needed SABA1
Since most guidelines favour PRD, asthma management should strive to improve patient
adherence
to regular ICS as the standard approach, before symptom-driven dosing is considered5–14

37. 37
Looking at the evidences
Fluticasone Propionate
+ Salmeterol (FP/SAL)
ICS/LABA Combination

38. 38
FP/SAL PRD allows most patients to achieve good
asthma control
This was a 1-year, stratified, randomised, double-blind, parallel-group study comparing the efficacy of FP/SAL (n=1,709) or FP alone (n=1,707) in achieving asthma control in patients aged 12–80 with ≥6 months history of asthma and an
improvement in FEV1 ≥15% to SABA. Asthma control was defined as per GINA/NIH guidelines.
FEV1, forced expiratory volume in one second; FP, fluticasone propionate; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroid; LABA, long-acting 2-agonist; NIH, National Institutes of Health; SABA, short-acting ß2-agonist; SAL,
salmeterol.
This graph has been independently created by GSK from the original published in Bateman ED, et al. Am J Respir Crit Care Med 2004;170:836–44.
In the GOAL study, the
proportion of patients achieving
a week of well-controlled
asthma increased progressively
over time to a
(non-cumulative) maximum of
77% with FP/SAL
With FP alone, a maximum of
68% of patients achieved a
well-controlled week
80
60
40
20
0
-4 0 4 8 16
12 20 24 28 32 36 40 44 48 52
100
Asthma
patients
with
a
well-controlled
week
on
FP/SAL
(%)
Week of study
Max percentage: 77.0%

39. 39
Improvement in asthma endpoints with FP/SAL PRD
Daytime asthma symptoms
FP/SAL treated patients
achieved symptom-free 5
days/week compared with
3.5 days for ICS alone
31% of the patients treated
with FP/SAL had ZERO
Night-time awakening versus
22% patients for ICS alone
Any night-time “awakening”
Reliever Free days
FP/SAL treated patients had
rescue free 6 days out of 7 days.
(Rescue-free days at 52 weeks /
stratum 2 column: 87.8% vs.
72.0%. FP/SAL vs. FP. OR 2.24
(1.78, 2.82); p<0.001.)
With FP/SAL treatment annualized
rate of severe exacerbations was
exacerbations, 0.02 events/patient/
year versus 0.03; p<0.001 for all
treatment differences
Exacerbation
Woodcock AA et al. Improvement in asthma endpoints when aiming for total control: Salmeterol/Fluticasone Propionate versus Fluticasone Propionate alone. Prim Care Respir J 2007;16:155–61

40. 40
FEV1 and quality of life scores continually improve
with sustained regular FP/SAL dosing
*During Phase I the dose escalation phase, treatment was “stepped up” every 12 weeks until totally controlled asthma was achieved or the highest dose of study drug reached (FP/SAL 500/50 μg twice daily or FP 500 μg twice daily).
Patients entered Phase II either after achieving totally controlled asthma or after 12 weeks on the maximum dose of study medication. This was a 1-year, stratified, randomised, double-blind, parallel-group study in patients
aged 12–80 with ≥6 months’ history of asthma and an improvement in FEV1 ≥15% to SABA. Asthma control was defined as per GINA/NIH guidelines.
AQLQ, Asthma Quality of Life Questionnaire; FEV1, forced expiratory volume in one second; FP, fluticasone propionate; ICS, inhaled corticosteroid;
LABA, long-acting 2-agonist; NIH, National Institutes of Health; S1/2/3, stratum 1/2/3; SABA, short-acting ß2-agonist; SAL, salmeterol.
These charts have been independently created by GSK from the original data published in Bateman ED, et al. Am J Respir Crit Care Med 2004;170:836–44.
Further improvements were observed in FEV1 and quality of life with sustained fixed-dose ICS treatment,
after completion of the GOAL Phase I dose-escalation*
FP (n=1,707) FP/SAL (n=1,709)
Hatched sections indicate further increases observed with ICS-fixed dosing in Phase II*
0.45
0.31
0.35
0.22
0.29
0.17
0.07
0.03
0.02
0.02
0.03
0.01
0.00
0.10
0.20
0.30
0.40
0.50
0.60
Adjusted
mean
change
from
baseline,
L*
Steroid-naïve (S1) Low-dose ICS (S2) Moderate-dose ICS (S3)
FEV1
1.5
1.3 1.3
1.0
1.1
0.8
0.1
0.1
0.0
0.2 0.1
0.2
0.0
0.4
0.8
1.2
1.6
Adjusted
mean
change
from
baseline
score*
Steroid-naïve (S1) Low-dose ICS (S2) Moderate-dose ICS (S3)
AQLQ
End of Phase I*
End of Phase II*
Baseline

41. 41
Asthma control continually improves with sustained
regular FP/SAL dosing over 52 weeks
*During Phase I the dose escalation phase, treatment was “stepped up” every 12 weeks until totally controlled asthma was achieved or the highest dose of study drug reached (FP/SAL 500/50 μg twice daily or FP 500 μg twice daily).
Patients entered Phase II either after achieving totally controlled asthma or after 12 weeks on the maximum dose of study medication. This was a 1-year, stratified, randomised, double-blind, parallel-group study in patients
aged 12–80 with ≥6 months history of asthma and an improvement in FEV1 ≥15% to SABA. Asthma control was defined as per GINA/NIH guidelines.
FP, fluticasone propionate; ICS, inhaled corticosteroid; LABA, long-acting 2-agonist; NIH, National Institutes of Health; S1/2/3, stratum 1/2/3; SABA, short-acting ß2-agonist; SAL, salmeterol.
These charts have been independently created by GSK from the original charts published in Bateman ED, et al. Am J Respir Crit Care Med 2004;170:836–44.
Of patients continuing regular ICS treatment after achieving their target level of asthma control in GOAL Phase I,
a further 8–12% went on to achieve totally controlled asthma in Phase II*
0
10
20
30
40
50
60
70
80
90
100
Proportion
of
patients
(%)
Steroid-naïve (S1) Low-dose ICS (S2) Moderate-dose ICS (S3)
Well-controlled asthma
FP (n=1,707)
FP/SAL (n=1,709)
Hatched sections indicate further improvements observed with ICS-fixed dosing in Phase II*
0
10
20
30
40
50
60
70
80
90
100
Proportion
of
patients
(%)
Steroid-naïve (S1) Low-dose ICS (S2) Moderate-dose ICS (S3)
Totally controlled asthma
8–12% of patients
during Phase II

42. 42
Asthma control over 3 years in a real-life study with
FP/SAL PRD
of patients (168/229) on FP/SAL
PRD treatment-maintained control of
their asthma at the end of 3 years
(versus: 21% (49/229) receiving FP
5% (12/229) receiving SAL).
Odd ratios for requiring increased treatment were 2.66
(p < 0.002) for patients initially randomized to FP and
9.38 (p < 0.0001) SAL, compared with SFC
At the end of 3 years, 31% of
patients treated with SFC no
longer had evidence of airway
hyper-reactivity
Time until 25% of patients first
required an increase in study
medication was 21 months for
SFC.
3-year study was a randomized, double-blind study for 12 months followed by a 2-year open period done in Sweden. Study involved 282 patients with mild to moderate asthma who were initially randomized to either Salmeterol / Fluticasone Propionate
combination (SFC), Salmeterol (SAL) or Fluticasone Propionate (FP) as monotherapy. During the open phase, treatments were adjusted by the investigating physician, as necessary, to achieve and maintain asthma control.
Lundbäck B et al. Asthma control over 3 years in a real-life study. Respir Med. 2009;103:348-355

43. 43
Choosing the right
inhaler for asthma
management

44. 44
Considerations while choosing inhaler device
Pulmonar
y function
Device
handling
Accurate &
consistent
dose
delivery
Required
inhaler
technique
Patient
preference
Usmani OS. Choosing the right inhaler for your asthma or COPD patient. Therapeutics and clinical
risk management. 2019;15:461.

45. 45
Consistent dose delivery at different flow rate with
Accuhaler
Dose delivery performance at different flow rates of FP/SAL dosing with Accuhaler 50/250 μg/blister device after
storage at 30˚C /60% relative humidity. Error bars show standard deviation
Sadler R. & Prime D. Allergology & Immunology (Japan), 2012; 19: 110-120.
Consistent dose delivered
Across all the dose strengths, the
Accuhalerdelivers a consistent
dose of 91.6% ± 8.5% and 88.1% ± 7.8%
(mean ± standard deviation)
(label claim) for Fluticasone Propionate
and Salmeterol respectively

46. 46
Dry Powder Inhalers Are Sensitive To External Environment
1. Janson C et al. Primary Care Respiratory Medicine 2016, 16053; doi:10.1038/npjpcrm.2016.53 15. Atkins PJ. Respir Care 2005;50(10):1304–1312 2. Sadler R. & Prime D. Allergology & Immunology (Japan), 2012;
19: 110-120. 3. Chrystyn H. The DiskusTM: a review of its position among dry powder inhaler devices. International journal of clinical practice. 2007 Jun;61(6):1022-36.
Environmental factors like, temperature and humidity, are key
factors which can impact stability and performance of a DPI
Accuhaler has each individual dose packed in blister foil, protecting dose from different
temperatures and humidity conditions
Dosing with Accuhaler remains consistent at different flow rates even after storage at
elevated temperature and humidity
Environmental factor considerations while choosing
the device

47. 47
Device Handling: Accuhaler
Least handling errors with Accuhaler®
Device handling errors with different inhalers
94% patients had zero handling
errors with Accuhaler
Results from prospective observational evaluations in 300
patients using MDI (without spacer) Device B, Accuhaler,
and Device A devices
MDI: Metered Dose inhaler. DPI: Dry Powder Inhaler.
Evaluations were conducted at 3 pulmonary clinics in
Jordan, in 300 patients from
February 2006 until August 2006. Incorrect handling was
defined as improper technique in any of the predefined
essential steps. Study
population 73% bronchial asthma, 18.3% COPD, 8.7%
other diagnosis
Khassawneh BY et al. Respir Care 2008; 53:324-28

48. 48
Ease of use & Patient preference
It is recognized that patient factors such as ease of use and patient preference directly
affect treatment compliance.
1. Chrystyn H. The DiskusTM: a review of its position among dry powder inhaler devices. International journal of clinical practice. 2007 Jun;61(6):1022-36. 2. Seretide. Prescribing Information, Version: SER-ACC-
EVR/PI/IN/2021/01 dated 14-June-2021 3. Clay MM, Huskisson SC, Jenkins MM. Ease of handling and clinical efficacy of a new multi-dose powder inhaler for the delivery of salmeterol in adult asthmatics. Eur Respir
J 1994; 7 (Suppl. 18): 163s.
Single training instruction
Two training session
74%
patients were able
to use the
Accuhaler correctly
99%
patients were able
to use the
Accuhaler correctly
Accuhaler preferred to previous device (53% vs.
TurbuhalerTM; 82% vs. DiskhalerTM; 83% vs.
RotahalerTM; 92% vs. SpinhalerTM)
Accuhaler offers ease of use with respect to
assessing the number of doses remaining,
reliable delivery and patient preference

49. 49
The ICS PRD approach targets core issues
in asthma management
HCP, healthcare professional; HRQoL, health-related quality of life; ICS, inhaled corticosteroid; PRD, proactive regular dosing; SABA, short-acting β2-agonist.
See slide notes for references.
ICSs effectively treat the airway inflammation underlying the
pathophysiology of asthma.1 The effects of ICSs may take several
months to reach a steady state, so regular treatment is key2
Regular ICS-based maintenance treatment with SABA reliever use
as-needed is proven to reduce symptoms and exacerbations
and improve HRQoL3,4
There is a lack of consensus in treatment guidelines,
but regular dosing is recommended in most countries around the
world as the most effective way to use ICS to improve symptoms,
asthma control, exacerbation risk and reduce mortality risk1,9–17
The improvement in asthma control and reduction in symptoms
achieved with ICS PRD decreases the need for and potential
reliance on reliever medications (e.g. SABAs)7,8
Proactive asthma management requires cooperation between patients
and HCPs to prevent poor adherence to regular maintenance
therapy.
For the best outcomes, ICS treatment should be started as soon as
possible after asthma diagnosis5,6
SUMMAR
Y
ICS PRD

50. 50
Asthma management should strive to improve
patient adherence to regular ICS
FP/SAL PRD allows most patients to achieve good asthma control
FEV1 and quality of life scores continually improve with sustained regular FP/SAL
dosing
Accuhaler provides consistent dose delivery at different flow rate with low handling
error
Appropriate selection and correct use of inhalation devices is an integral
component
in the management of asthma
SUMMAR
Y

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Key safety information of Seretide Accuhaler
Seretide Prescribing Information. Version: SER-ACC-EVR/PI/IN/2021/01 dated 14-June-2021
Contraindication: Hypersensitivity to the active substances or to any of the excipients
Adverse events with salmeterol xinafoate/fluticasone propionate include:
Very common ≥ 1/10 Headache
Common (≥1/100 to <1/10)
Candidiasis, pneumonia in COPD patients, hoarseness/dysphonia, muscle cramps and
arthralgia
The possibility of impaired adrenal response should always be borne in mind in emergency and elective situations likely to
produce stress and appropriate corticosteroid treatment considered. Treatment with salmeterol/fluticasone propionate should not
be stopped abruptly in patients with asthma.
It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroid is regularly monitored.
The dose of inhaled corticosteroid should be reduced to the lowest dose at which effective control of asthma is maintained.
Systemic effects may occur, particularly at high doses prescribed for long periods

52. 52
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory
Abbreviated Prescribing Information of SERETIDE ACCUHALER
(Fluticasone and Salmeterol Inhalation Powder, pre-metered BP)
ACTIVE INGREDIENTS: Seretide Accuhaler is a moulded plastic device having a foil strip with 28 or 60 regularly distributed blisters; each pre-metered unit (blister) contains powder for inhalation providing
Salmeterol Xinafoate IP equivalent to 50 mcg Salmeterol and Fluticasone Propionate IP 100mcg, 250mcg or 500mcg. THERAPEUTC INDICATIONS: Regular treatment of bronchial asthma, where use of a
bronchodilator and an inhaled corticosteroid are appropriate. Regular treatment of Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis. POSOLOGY AND METHOD OF
ADMINISTRATION: Inhalation only. Inform patients to regularly use SERTIDE ACCUHALER for optimum benefit, even when asymptomatic. Regularly reassess patients. Bronchial Asthma: Titrate to lowest
effective dose, could be once daily dose. Strength should provide appropriate fluticasone propionate dosage for severity of disease. Adults and adolescents 12 years and older: One inhalation (50/100, 50/250 or
50/500 mcg salmeterol/fluticasone propionate) twice daily. Children 4 years and older: One inhalation (50/100 mcg salmeterol/fluticasone propionate) twice daily. No data for use in children < 4 years. COPD: For
adult patients one inhalation (50/250 mcg to 50/500 mcg salmeterol/fluticasone propionate) twice daily. Special patient groups: No dose adjustment in elderly, renal or hepatic impairment patients.
CONTRAINDICATIONS: Hypersensitivity to any of ingredients and in patients with severe milk-protein allergy. SPECIAL WARNINGS and PRECAUTIONS FOR USE: Not for acute symptom relief.
Advise patients to have relief medication available at all times. Physician should review deterioration of control indicated by increasing use of short acting broncodilators and sudden progressive deterioration in
asthma control which is potentially life threatening and increasing corticosteroid therapy to be considered. Do not stop treatment abruptly in asthma patients; titrate-down therapy under supervision. Supervise
cessation of therapy in COPD that may be associated with symptomatic decompensation. Increased reporting of pneumonia in studies of COPD patients. Physicians to remain vigilant for possible development of
pneumonia in COPD patients. Administer with caution in active or quiescent pulmonary tuberculosis, thyrotoxicosis patients. Use with caution in patients with pre-existing cardiovascular disease, patients
predisposed to low levels of serum potassium. Possible systemic effects particularly at high doses prescribed for long periods include Cushing’s syndrome, Cushingoid features, adrenal suppression, growth
retardation in children and adolescents, decrease in bone mineral density, cataract, glaucoma and central serous chorioretinopathy. Titrate to lowest effective dose. Consider impaired adrenal response in emergency
and elective situations likely to produce stress and administer appropriate corticosteroid treatment. Regularly monitor height of children receiving prolonged treatment. Patients transferring from oral steroid to
inhaled fluticasone propionate to be treated with special care, adrenocortical function regularly monitored. Gradually withdraw systemic therapy following introduction of inhaled fluticasone propionate and
encourage patients to carry steroid warning card indicating possible need for additional therapy in times of stress. Very rare reports of blood glucose levels increases when prescribed to diabetes mellitus patients.
Avoid concomitant use of fluticasone propionate and ritonavir unless potential benefit outweighs systemic corticosteroid side-effects risk. Exercise caution when co-administering with strong CYP3A4 inhibitors
(e.g. ketoconazole). Paradoxical bronchospasm may occur; treat immediately with fast and short-acting inhaled bronchodilator. Discontinue SERETIDE immediately; assess patient and if necessary institute
alternative therapy. Tremors, subjective palpitations and headache have been reported, but tend to be transient and reduce with regular therapy. UNDESIRABLE EFFECTS: Very common (≥ 1/10): headache;
Common (≥1/100 to <1/10): candidiasis of mouth and throat, pneumonia (in COPD patients), hoarseness/dysphonia, muscle cramps, arthralgia; Uncommon (≥1/1000 to <1/100): cutaneous hypersensitivity
reactions, dyspnoea, cataract, hyperglycaemia, anxiety, sleep disorders, tremor, palpitations, tachycardia, atrial fibrillation, throat irritation, contusions; Rare (≥1/10,000 to <1/1000): oesophageal candidiasis,
anaphylactic reactions, glaucoma, behavioural changes including hyperactivity and irritability (predominantly in children), cardiac arrhythmias including supraventricular tachycardia and extrasystoles,
hypersensitivity reactions manifesting as angioedema (mainly facial and oropharyngeal oedema), bronchospasm, Cushing’s syndrome, Cushingoid features, adrenal suppression, growth retardation in children and
adolescents, decreased bone mineral density, paradoxical bronchospasm.
SER-ACC/API/IN updated 28 Jun 2021
Refer to full Prescribing Information before use. Registered medical practitioners can refer company website http://india-pharma.gsk.com/en-in/products/prescribing-information/ for full Prescribing
Information.
Please report adverse events with any GSK product to the company at india.pharmacovigilance@gsk.com.

53. 53
Registered medical practitioners can refer company website
http://india-pharma.gsk.com/en-in/products/prescribing-information/ for full Product Information.
GlaxoSmithKline Pharmaceuticals Ltd.,
Dr. Annie Besant Road, Worli,
Mumbai- 400 030. (India)
Please report adverse events with any GSK product to the company at
india.pharmacovigilance@gsk.com
Trademarks are owned by or licensed to the GSK group of companies
PM-IN-FPS-PPTX-230001 Date of Preparation: Feb 2023