ACLIDINIUM at doses of 200 and 400 micro grams vs placebo in COPD

• Research type

  Research Study

• Full title

  Efficacy and safety of aclidinium bromide at two dose levels vs placebo when administered to patients with moderate to severe chronic obstructive pulmonary disease (COPD)

• IRAS ID

  36776

• Contact name

  Paul JONES

• Sponsor organisation

  Laboratorios Almirall, S.A.

• Eudract number

  2009-011600-27

• ISRCTN Number

  No number provided

• Clinicaltrials.gov Identifier

  No number provided

• Research summary

  Chronic Obstructive Pulmonary Disease (COPD) is a growing health problem and is ranked as the sixth highest cause of death worldwide and is projected to be the third leading cause by 2020. COPD is characterised by occasional episodes of worsening of patient??s disease conditions (i.e. breathlessness, cough, chest tightness, fatigue), called acute exacerbations of COPD. These exacerbations may require changes in patient's medications or even hospitalisation in the most severe cases. The damage to the lungs (caused by cigarette smoking, airborne irritants or genetic conditions) that results in COPD is gradual, which is why most people are around 40 when they are diagnosed. Symptoms include an early morning cough, often called a smoker's cough, which produces a lot of phlegm, tightness in the chest and difficulty breathing. Current drug therapies centre on alleviation of symptoms by widening the airways. Bronchodilators (drugs that expand the airways) are a safe and effective group of drugs that are prescribed as a first line therapy to patients with COPD. They act by blocking nerve impulses (messages sent to the muscles causing them to contract) that cause bronchospams (constriction of airways). However, current bronchodilator therapies are limited by the fact that they are short acting and require frequent re-dosing. Almirall is developing a long-acting bronchodilator treatment (aclidinium bromide) for COPD. This study is designed to assess the long term effectiveness of aclidinium bromide administered via inhaler compared to matching placebo (an inhaler containing no active drug) over 24 weeks in patients with moderate to severe COPD. This will be a randomised, double-blinded, parallel group trial, meaning patients will be randomly (like tossing a coin) allocated to one of the treatment groups. Each treatment group will run at the same time, neither the participant nor the study doctor will know which group they will be in. The trial is a multi-centre study which will recruit approximately 810 patients worldwide.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  09/H1107/115

• Date of REC Opinion

  5 Mar 2010

• REC opinion

  Further Information Favourable Opinion