Phase II study to evaluate efficacy & safety of new treatment for COPD

• Research type

  Research Study

• Full title

  A multicentre, randomised, double-blind, active-controlled, 4-way cross-over study to evaluate the efficacy and safety of a free combination of 3 doses of Glycopyrrolate with fixed combination Beclomethasone Diproprionate plus Formoterol (Foster®) in a metered dose inhaler for the treatment of patients with Chronic Obstructive Pumlonary Disease (COPD)

• IRAS ID

  94813

• Contact name

  Dave Singh

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2011-003588-31

• Clinicaltrials.gov Identifier

  NCT01476813

• Research summary

  Chronic obstructive pulmonary disease (COPD) is a partially treatable disease that has varying severities in individual patients. Chronic cigarette smoking is the major cause of the disease, which is characterized by lung damage leading to airflow restrictions which are not fully reversible. The aim of treatment for the disease is to therefore reverse some of this airway obstruction if possible. Current treatments for stable COPD include the regular use of one or more bronchodilators (act to open the airways and relieve symptoms) as first line therapy with the addition of inhaled corticosteroids (ICS) depending on disease severity and repeated exacerbations. The main classes of bronchodilators include Ç?2-agonists such as long acting a Ç?2-agonists (LABA??s) and anti-cholingeric agents such as long acting muscarinic antagonists (LAMA??s). Current guidelines highlight that, for patients uncontrolled with bronchodilator monotherapy, combination therapy is recommended. Triple therapy with LABA, LAMA and ICS is widely used in clinical practice and it has been shown that ??triple therapy?? is more effective in terms of pulmonary function improvement and symptoms control as compared to bronchodilator monotherapy or ICS/LABA. This study will therefore involve the use of a LAMA (Glycopyrrolate bromide) and a ICS/LABA (Foster© - fixed combination of beclomethasone dipropionate (BDP) and formoterol fumarate (FF)), which are being developed by CHIESI Farmaceutici S.p.A. as a pressurised metered dose inhaler in a triple combination for the treatment of COPD. Both compounds have been or are currently already studied in patients suffering from COPD. Chiesi intends to develop a fixed dose combination of BDP/FF/Glycopyrrolate for COPD patients that would benefit from ICS/LABA and LAMA combined therapy. The aim of the study is to evaluate the additional bronchodilator effect of Glycopyrrolate when combined to Foster© at different doses after 1 week of treatment per dose.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  12/NW/0027

• Date of REC Opinion

  3 Feb 2012

• REC opinion

  Further Information Favourable Opinion