Aclidinium Bromide/Formoterol Fumarate in patients with stable COPD

• Research type

  Research Study

• Full title

  Efficacy and safety of Aclidinium Bromide/Formoterol Fumarate fixed-dose combinations compared with individual components and placebo when administered to patients with stable chronic obstructive pulmonary disease

• IRAS ID

  81379

• Contact name

• Sponsor organisation

  Forest Research Institute, Inc.

• Eudract number

  2011-001524-38

• Research summary

  Research Summa This is a 24-week treatment, prospective, randomised, parallel group, active and placebo controlled, double-blind, multinational and multicentre clinical trial.Patients meeting the entry criteria for this study will be randomised according to a randomisation ratio 2:2:2:2:1 (FDC 400/12 æg: FDC 400/6 æg: aclidinium monotherapy: formoterol monotherapy: placebo).Thus, 1 out of 9 patients will be assigned placebo treatment course.Study drug will be administered twice daily (in the morning between 8:00 and 10:00 am, and in the evening between 08:00 and 10:00 pm) by using a novel multidose dry powder inhaler (Genuair©) developed by Almirall Sofotec, GmbH.The study will consist of a 2 to 3 week run-in period designed to assess the stability of patients?? disease - therefore ensuring the suitability of the patients for the trial - and to establish the patients?? baseline characteristics. The run-in period will be preceded by a wash-out period in case patient was on prior treatment with any of the medications prohibited for this trial purposes (1 day to 1 month long, depending on the specific medication to be washed-out). The run-in period will be followed by a 24-week double-blind treatment period. Two weeks following each patient??s last dose of study drug, patients will complete a follow-up contact with the investigative site.The duration of the trial for each patient will be approximately 29 weeks (from Screening Visit to Follow-up Contact), in addition to the wash-out period prior to Screening Visit when needed.Two subsets of patients, each with 20% of the total trial population, will participate in either substudy (24hour Holter or Spirometry) involving additional visits and/or assessments.ry not yet available

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/NW/0482

• Date of REC Opinion

  23 Sep 2011

• REC opinion

  Further Information Favourable Opinion