QAB versus Seretide 26 week study

• Research type

  Research Study

• Full title

  A randomised, double-blind, parallel-group, 26-week study comparing the effiacacy and safety of indacaterol (Onbrez® Breezhaler® 150µg o.d.) with salmeterol/fluticasone propionate (Seretide® Accuhaler® 50µg/500µg b.i.d.) in patients with moderate chronic obstructive pulmonary disease.

• IRAS ID

  92875

• Contact name

  Amr Radwan

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-003732-31

• ISRCTN Number

  not known

• Research summary

  Chronic Obstructive Pulmonary Disease is a disease of progressive airflow obstruction which affects approximately 20% of chronic cigarette smokers. It is a major cause of poor health and death worldwide and contributes significantly to health care costs and co-morbidity. Current treatment guidelines recommend the use of one or more inhaled bronchodilators such as long-acting Ç?2-adrenergic receptor agonists [LABA] (e.g. salmeterol or indacaterol) and long-acting muscarinic receptor antagonists [LAMA] (e.g. tiotropium). These are established and widely used treatment options for COPD. Inhaled corticosteroids (ICS) are indicated for patients with more severe COPD with recurrent exacerbations and not for patients with moderate COPD or who do not experience recurrent exacerbations. However, they are still widely used and many moderate COPD patients are prescribed a fixed dose combination of a LABA plus ICS. Indacaterol (Onbrez©) is a long acting bronchodilator approved for once a day maintenance treatment in patients with COPD. So far there has been no study comparing the effect and safety of Indacaterol against a fixed dose combination. Therefore this study will compare the effect and safety of Indacaterol with that of Seretide© Accuhaler©, which is a fixed dose combination of Salmeterol (LABA) witfluicasone (ICS), which is administered twice daily. The study will be performed in up to 15 countries worldwide and will consist of approximately 600 adults with moderate COPD who are receiving ongoing treatment with Seretide© Accuhaler© and have not experienced a COPD exacerbation in the past 12 months (prior to visit 1). The UK will be recruiting 130 patients at approximately 13 centres. The patients will be randomised to receive either Indacaterol or Seretide (ratio of 1:1) for 26 weeks treatment and will attend the clinic a maximum of 9 visits, and will be contacted 3 times via the telephone to confirm their general health and any adverse reactions.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/0094

• Date of REC Opinion

  23 Jan 2012

• REC opinion

  Favourable Opinion