Efficacy & safety of PT003, PT005 and PT001 in moderate to severe COPD
Research type
Research Study
Full title
A Randomized, Double Blind, Chronic Dosing (24 Weeks), Placebo-Controlled, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects with Moderate to Very Severe COPD, Compared with Placebo
IRAS ID
167822
Contact name
David Collier
Contact email
Sponsor organisation
Pearl Therapeutics, Inc.
Eudract number
2014-004712-10
Duration of Study in the UK
1 years, 5 months, 25 days
Research summary
Chronic obstructive pulmonary disease (COPD) is an increasing cause of illness and death caused by multiple factors and worsens with age. It is characterised by air-flow limitation that is progressive in nature. Pearl Therapeutics, the sponsor of this study is developing a combination product, Glycopyrronium and Formoterol Fumarate (GFF) Inhalation Aerosol, hereafter referred to as GFF MDI (metered dose inhaler), as a maintenance inhaler treatment in patients with COPD. Pearl Therapeutics is also developing the individual products, Glycopyrronium (GP) Inhalation Aerosol, hereafter referred to as GP MDI and Formoterol Fumarate (FF) Inhalation Aerosol, hereafter referred to as FF MDI as maintenance bronchodilator treatments in patients with COPD.
The overall objective of this study is to assess the efficacy and safety of treatment with GFF MDI, FF MDI, and GP MDI compared with each other and with Placebo (substance that has no medicinal value) MDI over 24 weeks in subjects with moderate to very severe COPD. The study also evaluates the effects of study drug on lung function, on flare-up of COPD and compares the change in use of rescue medication.
Approximately 1614 participants will be enrolled into the study. Participants will receive one of the study drugs or the placebo in a 7:6:6:3 (GFF MDI, FF MDI, GP MDI, and Placebo MDI) ratio. Each participant will be in the study for approximately 30 weeks from the time of screening. During this period, lung function tests, laboratory tests and questionnaires will be used to assess the efficacy and safety of the study drug in participants.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
15/LO/0523
Date of REC Opinion
5 Jun 2015
REC opinion
Further Information Favourable Opinion