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.