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Recent Advances In
Asthma & COPD
Dr.Tinku Joseph
DM Resident
Pulmonary Medicine
AIMS, Kochi
Jan-Dec 2016
Contents
Asthma
COPD
Glycopyrronium + Indacetarol
 SPARK, BLAZE, ILLUMINATE , SHINE and ENLIGHTEN
(2012-2015)
 Increase in Lung function
 Improvement in health related QoL, and Dyspnea
Glycopyrronium + Indacaterol fixed dose
combination
FLAME TRIAL – June 2016
Fluticasone furoate –Vilanterol in COPD
September 2016
ROFLUMILAST
 PDE4 inhinbitor
 Reduce inflammation
 Inhibits breakdown of
intracellular cyclic AMP
 Not a bronchodilator – no use
in acute spasm
 Reduces exacerbations
 500mcg OD
 GI intolerence, headache and
sleep disturbances.
 AURA study
ROFLUMILAST
Endobronchial valves/coils
Endobronchial valves
 Significantly improved FEV1 , 6MWD
 Adverse events more
 Pneumothorax
 Valve replacement
 Conclusion –
 Effective in highly selected patients
 with out collateral ventilation
 who are ready to accept adverse events
Revolens study
 Coil treatment
 Homogeneous Emphysema
 The coil group had significant improvements in lung
function and quality of life at 6 and 12 months.
 Pneumonia
Endobronchial Coils
Endobronchial Coils
Endobronchial Coils
 Taken together, these studies show that
endobronchial valves or nitinol coils can:
 Improve lung function
 Exercise tolerance
 Quality of life in carefully selected patients with
severe emphysema who are willing to accept the
associated risks.
Endobronchial valves/coils
Smoking
 Varenicline -: first-line drug treatment
 Bupropion is a second-line therapy. It may be associated with
an increased risk of seizures and drug interactions
 Marginal evidence -: Electronic cigarettes might facilitate
smoking cessation.
 Quit rates are not yet comparable with those of the drugs
approved on the Pharmaceutical Benefits Scheme.
 Varenicline – 5 trials
 The first two were dose-finding studies with bupropion as an
active comparator in one
 Two large phase III studies with identical design compared
varenicline 1mg bid with placebo and bupropion 150 mg bid.
 At one year follow-up- varenicline was 2.4 times more effective
than placebo and significantly better than bupropion in one of the
studies and marginally superior in the other.
 The most common side effects were nausea and insomnia
New drugs
 Dianicline - 1 phase II trial - Promising results
 Rimonabant has shown some short term efficacy. However,
its effects do not seem to be significantly better than those for
the currently available treatments
 The current nicotine “vaccines” clearly do not give very long
lasting protection because the antibody titers do not remain
elevated for many months.
E-Cigarette
E-cigarette
 Vaping
 Regulation varies from country to country
 Achievement of abstinence was substantially lower
than the researchers anticipated for the power
calculations,
 They had insufficient statistical power to conclude
superiority of nicotine e-cigarettes to patches or to
placebo e-cigarettes.
 No significant differences in adverse events were
identified.
Reslizumab
 Monoclonal antibody to interleukin (IL)-5
 FDA approved
 Cinquair
 Add-on maintenance therapy of severe
asthma In patients >18 yrs or older
 Eosinophilic phenotype
Reslizumab: Description and
Production
 Sterile solution in single-use vial
 3 mg/kg IV q4wk infused over 20-50 minutes
Adverse Effects
 Elevated CPK (14%)
 Oropharyngeal pain (2.6%)
 Myalgias (1%)
 Anaphylaxis (0.3%)
Benralizumab
 Investigational molecule
 Anti-interleukin (IL)-5 receptor antibody.
 Two trials
 Reduced exacerbations in patients with moderate to
severe asthma who had elevated peripheral blood
eosinophil counts.
November 2016
Benralizumab
Benralizumab
Fluticasone + Salmeterol
 Small increase in asthma-related deaths associated with salmeterol
 Black box warning – FDA
 Combined with Fluticasone
 Safety of S+F – Multicentric trial 12000 patients
 Inhaled F vs. F + S
 No differences in SAE, no deaths, no asthma related
hospitalizations
 The AUSTRI trial
September 2016
September 2016
Omalizumab for allergic asthma in children 6 to 11
years of age
 Monoclonal antibody to immunoglobulin E (IgE)
 Indication-:
 patients with moderate to severe persistent asthma and
sensitization to perennial aeroallergens who are inadequately
controlled on inhaled glucocorticoids
 US-FDA has now lowered the approved age range from 12 to 6
years of age,
July 2016
Evaluation of recurrent wheezing in children <2
years of age
ATS recommendation
 unresponsive to bronchodilators or inhaled or systemic
glucocorticoids
 Suggested evaluation:
 videofluoroscopic swallowing study (modified barium
swallow) for possible swallowing dysfunction.
 24-hour esophageal pH monitoring for assessment of GERD.
 FOB- (BAL) to assess for lower airway bacterial infection
August 2016
Recent advances in Asthma & COPD by  Dr.Tinku Joseph
Recent advances in Asthma & COPD by  Dr.Tinku Joseph

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Recent advances in Asthma & COPD by Dr.Tinku Joseph

  • 1. Recent Advances In Asthma & COPD Dr.Tinku Joseph DM Resident Pulmonary Medicine AIMS, Kochi Jan-Dec 2016
  • 3.
  • 4. Glycopyrronium + Indacetarol  SPARK, BLAZE, ILLUMINATE , SHINE and ENLIGHTEN (2012-2015)  Increase in Lung function  Improvement in health related QoL, and Dyspnea
  • 5. Glycopyrronium + Indacaterol fixed dose combination
  • 6. FLAME TRIAL – June 2016
  • 7.
  • 8.
  • 9. Fluticasone furoate –Vilanterol in COPD September 2016
  • 10.
  • 11.
  • 12. ROFLUMILAST  PDE4 inhinbitor  Reduce inflammation  Inhibits breakdown of intracellular cyclic AMP  Not a bronchodilator – no use in acute spasm  Reduces exacerbations
  • 13.  500mcg OD  GI intolerence, headache and sleep disturbances.  AURA study ROFLUMILAST
  • 15.
  • 16.
  • 17. Endobronchial valves  Significantly improved FEV1 , 6MWD  Adverse events more  Pneumothorax  Valve replacement  Conclusion –  Effective in highly selected patients  with out collateral ventilation  who are ready to accept adverse events
  • 18.
  • 19.
  • 20. Revolens study  Coil treatment  Homogeneous Emphysema  The coil group had significant improvements in lung function and quality of life at 6 and 12 months.  Pneumonia Endobronchial Coils
  • 21.
  • 22.
  • 25.  Taken together, these studies show that endobronchial valves or nitinol coils can:  Improve lung function  Exercise tolerance  Quality of life in carefully selected patients with severe emphysema who are willing to accept the associated risks. Endobronchial valves/coils
  • 26.
  • 27.
  • 28.
  • 29.
  • 30.
  • 31. Smoking  Varenicline -: first-line drug treatment  Bupropion is a second-line therapy. It may be associated with an increased risk of seizures and drug interactions  Marginal evidence -: Electronic cigarettes might facilitate smoking cessation.  Quit rates are not yet comparable with those of the drugs approved on the Pharmaceutical Benefits Scheme.
  • 32.  Varenicline – 5 trials  The first two were dose-finding studies with bupropion as an active comparator in one  Two large phase III studies with identical design compared varenicline 1mg bid with placebo and bupropion 150 mg bid.  At one year follow-up- varenicline was 2.4 times more effective than placebo and significantly better than bupropion in one of the studies and marginally superior in the other.  The most common side effects were nausea and insomnia
  • 33. New drugs  Dianicline - 1 phase II trial - Promising results  Rimonabant has shown some short term efficacy. However, its effects do not seem to be significantly better than those for the currently available treatments  The current nicotine “vaccines” clearly do not give very long lasting protection because the antibody titers do not remain elevated for many months.
  • 35. E-cigarette  Vaping  Regulation varies from country to country  Achievement of abstinence was substantially lower than the researchers anticipated for the power calculations,  They had insufficient statistical power to conclude superiority of nicotine e-cigarettes to patches or to placebo e-cigarettes.  No significant differences in adverse events were identified.
  • 36.
  • 37.
  • 38.
  • 39. Reslizumab  Monoclonal antibody to interleukin (IL)-5  FDA approved  Cinquair  Add-on maintenance therapy of severe asthma In patients >18 yrs or older  Eosinophilic phenotype
  • 40.
  • 41. Reslizumab: Description and Production  Sterile solution in single-use vial  3 mg/kg IV q4wk infused over 20-50 minutes
  • 42. Adverse Effects  Elevated CPK (14%)  Oropharyngeal pain (2.6%)  Myalgias (1%)  Anaphylaxis (0.3%)
  • 43.
  • 44. Benralizumab  Investigational molecule  Anti-interleukin (IL)-5 receptor antibody.  Two trials  Reduced exacerbations in patients with moderate to severe asthma who had elevated peripheral blood eosinophil counts. November 2016
  • 47.
  • 48. Fluticasone + Salmeterol  Small increase in asthma-related deaths associated with salmeterol  Black box warning – FDA  Combined with Fluticasone  Safety of S+F – Multicentric trial 12000 patients  Inhaled F vs. F + S  No differences in SAE, no deaths, no asthma related hospitalizations  The AUSTRI trial September 2016
  • 50.
  • 51.
  • 52. Omalizumab for allergic asthma in children 6 to 11 years of age  Monoclonal antibody to immunoglobulin E (IgE)  Indication-:  patients with moderate to severe persistent asthma and sensitization to perennial aeroallergens who are inadequately controlled on inhaled glucocorticoids  US-FDA has now lowered the approved age range from 12 to 6 years of age, July 2016
  • 53. Evaluation of recurrent wheezing in children <2 years of age ATS recommendation  unresponsive to bronchodilators or inhaled or systemic glucocorticoids  Suggested evaluation:  videofluoroscopic swallowing study (modified barium swallow) for possible swallowing dysfunction.  24-hour esophageal pH monitoring for assessment of GERD.  FOB- (BAL) to assess for lower airway bacterial infection August 2016