QVA149 vs NVA237 and open label tiotropium in COPD

• Research type

  Research Study

• Full title

  A 52-week treatment, multi-center, randomized, double-blind, parallel-group, active controlled study to evaluate the effect of QVA149 (110/50 µg o.d.) vs NVA237 (50 µg o.d.) and open-label tiotropium (18 µg o.d.) on COPD exacerbations in patients with severe to very severe chronic obstructive pulmonary disease (COPD).

• IRAS ID

  46065

• Contact name

  Amr Radwan

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2009-013256-69

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Chronic Obstructive Pulmonary Disease (COPD) is a disease of the lungs characterized by airflow limitation which is not fully reversible. Frequent COPD exacerbations (worsening of symptoms)reduce the patients quality of life and lung function which can lead to ill health, hospitalization and deaths. Therefore effective management of COPD includes both prevention and treatment of their exacerbations. QVA149 is a fixed dose, dry powder combination of two medications indacaterol (QAB149) and glycopyrronium bromide (NVA237) which is being developed as an inhaled medicine for the treatment of COPD. Current data indicates that these drugs can reduce the rate of COPD exacerbations. Both medicines on their own are effective in providing long-term bronchodilation in terms of improvement in symptoms but the possible beneficial effects of them as a fixed-dose combination has to be demonstrated. Currently, there is no fixed-dose combination of these two long acting medicines. Tiortopium is a similar long acting medicine which is already on the market and is being used to compare the new treatments to. If a patient gives consent to take part, they will be randomly assigned to one of three treatment groups. QVA149 (the combination) NVA237 Open label Tiotropium 130 UK patients will be recruited at approx 14 sites and remain in the study for a 12 month period. 2000 patients will be recruited globally into the study. Patients will attend a maximum of 14 study visits.

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  10/H0402/21

• Date of REC Opinion

  15 Apr 2010

• REC opinion

  Further Information Favourable Opinion