Effect of fixed combination (BDP+FF) on exacerbation in severe COPD

• Research type

  Research Study

• Full title

  A 48-Week, Double Blind, Randomized, Multinational, Multicentre, 2-Arm Parallel Group, Reference Treatment Controlled Clinical Trial Of “FIXED COMBINATION” BECLOMETHASONE DIPROPIONATE PLUS Formoterol fumarate administered via pMDI (CHF 1535 Foster®) versus FORMOTEROL in Patients with Severe Chronic Obstructive Pulmonary Disease

• IRAS ID

  26309

• Eudract number

  2009-012546-23

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Chronic Obstructive Pulmonary Disease (COPD) is a preventable and partially curable disease, characterised by difficulties in breathing due to an abnormal inflammatory response of the lung. Episodes of acute worsening of symptoms are known as exacerbations. These can accelerate the decline in lung function and often require additional treatment. Reduction in exacerbation rates is one of the main treatment goals in COPD management, since exacerbations can significantly impact a patients' quality of life and prognosis. This study is looking to demonstrate that CHF1535 (combination of beclamethasone ultra fine and formoterol) twice daily is superior to Formoterol twice daily in terms of exacerbation rates and in terms of pulmonary function (change in pre-dose morning FEV1 from baseline to 12 weeks) in patients with severe COPD. There will be a 2 week run-in period followed by a 48 week treatment period, where patients will be assigned to either CHF1535 or Formoterol fumarate. A total of 1268 patients will be entered into this study, from numerous centres globally (Europe, South Africa, Latin America, Australia and New Zealand). Eligible patients will be over 40 years of age, of either sex, with a previous diagnosis of COPD. The information obtained from this study will help to develop a new effective combination drug for patients with COPD. This medication is expected to have a positive effect on patient compliance to treatment and to improve patients?? quality of life.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  09/H0505/103

• Date of REC Opinion

  21 Sep 2009

• REC opinion

  Further Information Favourable Opinion