A multicentre, 52 week, double blind Asthma study with QMF149

• Research type

  Research Study

• Full title

  A multi-center, randomized, 52 week treatment, doubleblind, triple-dummy, parallel-group study to assess the efficacy and safety of QMF149 compared with mometasone furoate in patients with asthma

• IRAS ID

  173717

• Contact name

  Gordon Crawford

• Contact email

  Gordon.Crawford@cpsresearch.co.uk

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2015-002529-21

• Duration of Study in the UK

  2 years, 5 months, 29 days

• Research summary

  This is a clinical research study to find out if the drug QMF149 delivered via single dose dry powder inhaler (SDDPI), referred to as the Concept1 device is safe and has beneficial effects in people who have asthma. QMF149 is an inhaled fixed dose combination of indacaterol acetate, a long acting beta agonists with a 24-hour duration of action and mometasone furoate (MF) which is an inhaled corticosteroid, as a once daily (o.d.) maintenance treatment of asthma.

  The following are the possible treatments:
   QMF149 via Concept1 inhaler device at the dosage of 150/160 μg once a day
   QMF149 via Concept1 inhaler device at the dosage of 150/320 μg once a day
   Mometasone furoate (MF) via Twisthaler® inhaler at the dosage of 400 μg once a day
   Mometasone furoate (MF) via Twisthaler® inhaler device, at the dosage of 800 μg
  (400 μg twice a day)
   Salmeterol xinafoate/fluticasone propionate via Diskus® (also named Accuhaler®) inhaler device at the dosage of 50/500 μg, to be taken twice a day.

  Only one of the inhalation devices will contain the active medicine inside. The others will contain a placebo (dummy drug).
  These medicines work on reducing inflammation on your lungs and opening up your airways.

• REC name

  Scotland B REC

• REC reference

  15/SS/0194

• Date of REC Opinion

  2 Dec 2015

• REC opinion

  Further Information Favourable Opinion