ACLIDINIUM BROMIDE vs placebo in patients with COPD

• Research type

  Research Study

• Full title

  A multiple dose, randomised, double-blind, placebo controlled, 2 period crossover clinical trial to assess the effect of aclidinium bromide 400 µg BID on exercise endurance in patients with stable moderate to severe chronic obstructive pulmonary disease (COPD).

• IRAS ID

  84310

• Contact name

  Dave Singh

• Contact email

  dsingh@meu.org.uk

• Sponsor organisation

  Almirall. S.A.

• Eudract number

  2011-002665-38

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  During recent years scientists involved in studies of Chronic Obstructive Pulmonary Disease (COPD) have recognised dynamic hyperinflation (air trapping in the lungs because of exercise) playing an important role in the difficulty to breath and the reduced exercise capacity related to COPD. Limitation in exercise capacity represents an important feature of COPD, and is one of the main factors to negatively impact patient??s quality of life. Medications aimed to treat COPD also aim to improve exercise endurance of COPD patients.Almirall, the sponsor of this study, would like to investigate the effect of aclidinium bromide inhalation powder on exercise endurance, hyperinflation and dyspnoea (shortness of breath) in patients with stable moderate to severe COPD. Aclidinium bromide is a new drug with the potential to sustain enlarged lung airways. Approximately 110 participants will be involved in approximately 18 study centers globally. The treatment period is 3 months. Following a run in period, eligible participants will be assigned to one of the following 2 treatment sequences: Period 1 Period 2 Sequence A Aclidinium bromide 400æg BID Placebo Sequence B Placebo Aclidinium bromide 400æg BID This study is blinded: Neither the participant nor his/her doctor or the study team will know what treatment is given. With this Phase IIIb study Almirall hopes to gain significant evidence of improvement on exercise endurance, hyperinflation and dyspnoea of participants using the study drug.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  11/NW/0676

• Date of REC Opinion

  2 Dec 2011

• REC opinion

  Further Information Favourable Opinion