CQVM149B2302 to compare QVM149 with QMF149 in patients with asthma

• Research type

  Research Study

• Full title

  A multicenter, randomized, 52-week, double-blind, parallel-group,active controlled study to compare the efficacy and safety of QVM149 with QMF149 in patients with asthma

• IRAS ID

  190078

• Contact name

  Monica Couto

• Contact email

  monica.couto@novartis.com

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2015-002899-25

• Clinicaltrials.gov Identifier

  NCT02571777

• Duration of Study in the UK

  2 years, 3 months, 26 days

• Research summary

  This study is in patients with asthma which is a disease of airway hyper-responsiveness and associated variable airflow obstruction. An estimated 300 million people are affected worldwide. It is a major cause of poor health and death worldwide and contributes significantly to healthcare costs.

  Recently, a long-acting muscarinic antagonist (LAMA) called tiotropium has been approved in the EU as an add on maintenance treatment in adults who are currently treated with a inhaled corticosteroids (ICS) and long-acting beta2 agonists (LABA) and have had one or more severe asthma exacerbations in the last year. The global asthma guidelines (GINA) were also recently updated to incorporate this add on therapy.

  The treatments under assessment in this study are QVM149 (LABA, LAMA and ICS fixed dose combination)and QMF149 (LABA and ICS fixed dose combination. Both medications use the same type of inhaler device. If participants give consent, then complete a screening and run-in period and are deemed eligible they are randomly assigned to 1 of 5 treatment groups, either:
  - QVM149 at one of 2 dose levels or
  - QMF149 at one of 2 dose levels or
  - salmeterol xinafoate/fluticasone propionate(a LABA and ICS combination) which is already approved for the maintenance treatment of asthma in adults and adolescents

  Participants will also receive a short acting beta agonist (SABA) rescue medication in case of worsening asthma symptoms.

  The study will consist of a screening period of up to 2 weeks, a run-in period of 2 weeks where participants will receive open label salmeterol/fluticasone as part of the study, a treatment period of 52 weeks and a 30 day safety follow up period.

  The aim is to include 3155 participants worldwide in the treatment period, of which 180 will be from the UK at approximately 25 sites. A screen failure rate of about 40% is expected during the run-in period.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  16/LO/0677

• Date of REC Opinion

  10 Jun 2016

• REC opinion

  Further Information Favourable Opinion