AFFIRM- COPD Aclidinim and Formoterol Findings in Respiratory Medicine

• Research type

  Research Study

• Full title

  A randomised, double-blind, double-dummy, active-controlled study evaluating the efficacy, safety and tolerability of twice-daily Aclidinium bromide/Formoterol fumarate compared with twice-daily Salmeterol/Fluticasone propionate for 24 weeks treatment in symptomatic patients with chronic obstructive pulmonary disease (COPD)

• IRAS ID

  130139

• Contact name

  Alyn Morice

• Sponsor organisation

  Almirall, S.A.

• Eudract number

  2013-000116-14

• ISRCTN Number

  NP

• Clinicaltrials.gov Identifier

  NP

• Research summary

  Chronic obstructive pulmonary disease (COPD), a common preventable and treatable disease, is characterised by persistent airflow limitation that is usually progressive caused by structural changes in the airways resulting from repeated injury and repair and by constriction of the airway and lungs. Shortness of breath, chronic cough and coughing up mucus are the most common symptoms.

  Although there is no cure for COPD, the symptoms are treatable. The most common are bronchodilators, which relax smooth muscle around the airways, and corticosteroids, which interfere in the immune system that turns inflammation down. There are two types of bronchodilators; LABAs (Long Acting Beta2-agonists) which stimulate the β2 receptors (a molecule that receives chemical signals) and LAMAs (Long-acting Muscarinic Antagonist) which block stimulation from cholinergic nerves (transmits through nervous system), both LABAs and LAMAs cause the airways to relax by different mechanisms.

  Almirall, S.A. and Forest Laboratories, Inc., are developing a fixed dose combination (FDC) of Aclidinium Bromide, a novel LAMA, combined with Formoterol Fumarate, a LABA, for the treatment of COPD.

  Almirall, S.A. is sponsoring this study to see whether a FDC of a LABA and LAMA together is superior in the treatment of COPD for men and women aged 40 and older. The novel LABA/LAMA combination (Genuair®) is being compared to a LABA/Corticosteroid combination of Salmeterol/Fluticasone propionate (Seretide®).

  This study is randomised and double-blind meaning that the treatment a participant will receive is allocated randomly, like tossing a coin, and neither the patient nor the study doctor will know whether the patient receives Genuair® or Seretide®. The study is double-dummy meaning there are 2 placebos involved.

  Participants will be allocated to one of 2 treatment groups using a ratio of 1:1:
  1. Aclidinium Bromide 400 µg / Formoterol Fumarate 12 µg and Placebo Salmeterol 50 µg / Fluticasone Propionate 500 µg
  2. Salmeterol 50 µg / Fluticasone Propionate 500 µg and Placebo Aclidinium Bromide 400 µg / Formoterol Fumarate 12 µg

  About 900 participants in approximately 170 centres in 15 countries will participate in this multicentre and multinational clinical trial.

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  13/LO/1024

• Date of REC Opinion

  16 Aug 2013

• REC opinion

  Further Information Favourable Opinion