REACT

• Research type

  Research Study

• Full title

  Effect of roflumilast on exacerbation rate in patients with COPD treated with fixed combinations of LABA and ICS. A 52-week, randomised double-blind trial with roflumilast 500 µg versus placebo The REACT-trial

• IRAS ID

  74631

• Contact name

  Peter MA Calverley

• Sponsor organisation

  Takeda Development Centre Europe Ltd

• Eudract number

  2010-019685-87

• Research summary

  Effect of fluilast on exacerbation rate in patients with chronic obstructive pulmonary disease (COPD) treated with fixed combinations of LABA and ICS. A 52-week, randomised double-blind trial with fluilast 500 æg versus placebo - the REACT trial. fluilast is the first approved drug of a new type of COPD medications, called selective phosphodiesterase 4 inhibitors. fluilast inhibits the phosphodiesterase-4 enzyme in lung tissue and in inflammatory cells considered important in COPD pathogenesis. fluilast works by a mechanism different from that of bronchodilators and is used in addition to bronchodilators. This is a 52-week, randomised double-blind trial sponsored by Nycomed GmbH. The purpose of this trial is to find out if treatment with fluilast works better than placebo when added on to fixed combinations of a long-acting beta2-agonist and an inhaled glucocorticosteroid. It is planned that 1,934 patients will participate at approximately 200 centers in 21 countries around the world. Approximately 60 participants will be recruited in the UK. The trial will enroll patients suffering from severe COPD associated with chronic bronchitis and with a history of frequent exacerbations, who are on maintenance treatment with a fixed combination of a long-acting beta2-agonist and an inhaled glucocorticosteroid. During the trial, half of the participants will be assigned by chance to receive fluilast and half of the participants to receive placebo. Participants will continue to take their regular, prescribed fixed combination medication. The trial duration for each participant will be approximately 68 weeks, with 9 to 11 clinic visits. During the visits participants will have various tests, including lung function measurements and questionnaires. Participants will also get a diary and be asked to record daily their disease symptoms and rescue medication.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/NW/0173

• Date of REC Opinion

  27 Apr 2011

• REC opinion

  Further Information Favourable Opinion