Assessing Efficacy & Safety of PT010 versus PT003 & PT009 in COPD
Research type
Research Study
Full title
A Randomised, Double Blind, Multi Centre, Parallel Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations over a 52 Week Treatment Period in Subjects With Moderate to Very Severe COPD
IRAS ID
179908
Contact name
Elizabeth Sapey
Contact email
Eudract number
2014-005671-92
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 9 months, 0 days
Research summary
This is a medical research study to test investigational drugs for the treatment of chronic obstructive pulmonary disease (COPD).
Investigational or experimental means that the study drugs are not yet approved for sale or for use.
Chronic obstructive pulmonary disease (COPD) is a progressive and debilitating lung disease that makes breathing difficult. It is an increasing cause of illness and death caused by multiple factors and worsens with age. Typical COPD symptoms include, chronic cough, wheezing, dyspnoea or shortness of breath, fatigue and recurrent respiratory infections.
The study drugs being developed by the study sponsor, (Pearl Therapeutics Inc.) are combination products that are orally inhaled (i.e. breathed through the mouth):
• [PT010]: a combination of Budesonide, Glycopyrronium and Formoterol Fumarate BGF inhalation aerosol hereafter referred to as BGF MDI (Metered Dose Inhaler)
• [PT003]: a combination of Glycopyrronium and Formoterol Fumarate referred to as (GFF MDI)
• [PT009]: a combination of Budesonide and Formoterol Fumarate referred to as (BFF MDI)
The main objective of this study is to assess the effect of BGF MDI relative to GFF MDI and BFF MDI on the rate of moderate or severe COPD exacerbations (i.e. “flare-ups”)
Other aims include:
Evaluation of:
• Safety
• COPD symptoms
• Quality of life
• All-cause mortality
• Overall and COPD-specific healthcare resource utilisation (HRU)
• Lung function and cardiovascular (sub-studies)Research design: A Phase 3, randomised, double-blind multi-centre, parallel-group study with a treatment period of 52 weeks
Approximately 8,000 to 12,000 patients will be randomised into one of four groups worldwide.
The study also comprises of follow-up and optional sub-studies.
A participant information sheet describing the study will be provided.
Participation in this study is entirely voluntary. Signed and dated informed consent will be obtained from each participant before any study procedures are performed.
REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
16/EM/0167
Date of REC Opinion
21 May 2016
REC opinion
Further Information Favourable Opinion