QVA149 versus Seretide exacerbation study

• Research type

  Research Study

• Full title

  A 52-week treatment, multi-center, randomized, double-blind, double-dummy, parallel-group, active controlled study to compare the effect of QVA149 (indacaterol maleate / glycopyrronium bromide) with salmeterol/fluticasone on the rate of exacerbations in subjects with moderate to very severe COPD.

• IRAS ID

  121051

• Contact name

  Dinesh Saralaya

• Contact email

  Dinesh.Saralaya@bthft.nhs.uk

• Eudract number

  2012-004966-16

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Chronic Obstructive Pulmonary Disease (COPD) is a disease of the lungs which is characeterised by airflow limitation and causes people to suffer symptoms such as shortness of breath and coughing. 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.

  The purpose of the study is to compare the effect of QVA149 against another type of fixed dose combination medication called Salmeterol/fluticasone on exacerbations in patients with moderate to very severe COPD. Salmeterol/fluticasone is another type of similar long acting medication containing an inhaled corticosteroid which is already on the market. Currently there is a lack of data comparing these two types of fixed dose combination therapy.

  If a patient gives consent to take part, they will be randomly assigned to one of two treatment groups on an equal basis:
  (1) QVA149 at a dose of (110/50 ug) once a day
  (2) Salmeterol/fluticasone at a dose of (50/500 ug) twice a day

  100 UK patients will be recruited at approx 20 sites and remain in the study for about 13 months. 3332 patients will be recruited globally into the study. Patients will attend 14 study visits.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  13/YH/0118

• Date of REC Opinion

  28 May 2013

• REC opinion

  Further Information Favourable Opinion