PT009 vs PT005 treatment of Moderate to Very Severe COPD (SOPHOS)
Research type
Research Study
Full title
A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 compared to PT005 on COPD Exacerbations over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD
IRAS ID
212039
Contact name
Paul Dorinsky
Sponsor organisation
Pearl Therapeutics, Inc. (Pearl)
Eudract number
2016-000155-28
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
122166, IND number
Duration of Study in the UK
2 years, 3 months, 2 days
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a common problem that often results in sudden episodes of worsening symptoms beyond normal day-to-day variations which are called exacerbations, which leads to a change in medication. Metered dose inhalers (MDIs) are the most common type of device to deliver inhaled drugs to patients with COPD. Yet, many COPD treatments, particularly dual and triple combinations of well-known inhaled medicines, have proven to be difficult to develop in an MDI for many reasons. The Sponsor, Pearl Therapeutics Inc., has overcome these challenges and has developed a new MDI formulation for the treatment of COPD.
The purpose of the study is to assess the effects of PT009 (Budesonide + Formoterol Fumarate MDI combination) versus PT005 (Formoterol Fumarate MDI alone) on COPD exacerbation rate and lung function in symptomatic patients with moderate to very severe COPD.
The study will examine COPD patients currently being treated with at least one or more approved COPD standard of care inhaled therapy and within the previous 12 months are classified as having either i) severe COPD with a documented history of ≥1 moderate or severe COPD exacerbation or ii) moderate COPD with a documented history of ≥ 2 moderate exacerbations or ≥1 severe COPD exacerbation.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
16/YH/0506
Date of REC Opinion
25 Jan 2017
REC opinion
Further Information Favourable Opinion