A trial to asses the anti-inflammatory effects of roflumilast in COPD

• Research type

  Research Study

• Full title

  Main Trial: A 16-week, randomised, placebo-controlled, double blind, and parallel group trial to assess the anti-inflammatory effects of Roflumilast in chronic obstructive pulmonary disease Sub-Trial: The Interaction Between Changes in the Lung Microbiota, Airway Inflammation and Mucin Production Resulting From Roflumilast Therapy

• IRAS ID

  85900

• Contact name

  Neil Barnes

• Sponsor organisation

  Nycomed GmbH

• Eudract number

  2011-000582-13

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  COPD (Chronic Obstructive Pulmonary Disease) presents a major health problem as an important cause of morbidity, mortality, and burden on health care systems worldwide. Symptomatic COPD patients at risk of exacerbations present the most important unmet medical need.Nycomed GmbH is conducting a phase 3 clinical study on the study drug fluilast. fluilast inhibits the PDE4 enzyme resulting in an anti-inflammatory effect in the lungs. The first marketing authorisation for fluilast has been granted by the European Commission on 05 July 2011 in the EU under the trade name Daxas. In the EU Daxas is used as a maintenence treatment of severe COPD associated with chronic bronchitis in adult patients with a history of frequent exacerbations as add on to bronchodilator treatment. The purpose of the study is to better understand the anti-inflammatory effects of the study drug fluilast in the target organ, the lungs which will help the development of further anti-inflammatory COPD treatments. Up to 150 participants will take part in this study across Europe. Approximately 60 participants will take part in the UK. Around 75 participants will be treated with fluilast and around 75 participants will be treated with placebo (dummy drug). Participation will be for at least 22 weeks and a maximum of 24 weeks. Participants will also be offered the option of taking part in a sub-study to look at the interaction between changes in microbes in the lung, airway inflammation and mucus production resulting from fluilast treatment. The main study involves the following procedures: physical exam, electrocardiogram, chest x-ray or CT scan (if required), blood tests, lung function measurements, sputum collection, bronchoscopy and bronchial biopsies. The sub-study involves additional sample collection during the 2 bronchoscopies performed in the main study.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  11/EE/0452

• Date of REC Opinion

  15 Dec 2011

• REC opinion

  Further Information Favourable Opinion