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. 2017 Feb 10;2017(2):CD012066. doi: 10.1002/14651858.CD012066.pub2

NCT02497001.

Trial name or title A Randomized, Double‐blind, Parallel‐Group, 24‐Week, Chronic‐Dosing, Multi‐center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared with Symbicort® Turbuhaler® (Kronos).
Methods Design: randomised, double‐blind, parallel‐group, double‐dummy, placebo‐controlled trial.
Countries: 2 countries (US and Canada).
Site: 94 centres.
Study duration: 24 weeks.
Study start: July 2015.
Run‐in period: unclear.
Participants Key inclusion criteria: %pred FEV1 < 80%.
Estimated enrolment: 1800.
Interventions 4‐arm trial.
Budesonide + glycopyrronium + formoterol fumarate inhalation aerosol (MDI, 320/14.4/9.6 μg, PT010).
 Glycopyrronium + formoterol fumarate inhalation aerosol (MDI, 14.4/9.6 μg, PT003).
 Budesonide + formoterol fumarate inhalation aerosol (MDI, 320/9.6 μg, PT009).
 Budesonide + formoterol fumarate inhalation powder (Turbuhaler)
Outcomes Change from baseline in morning pre‐dose trough FEV1 after follow‐up.
Starting date July 2015.
Contact information Raul Lima, 862‐777‐8094.
Notes Completion date: March 2017.
Registration: NCT02497001.
COI: Sponsored by Pearl Therapeutics, Inc.