Trials / Completed
CompletedNCT02497001
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)
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® as an Active Control in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,902 (actual)
- Sponsor
- Pearl Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.
Detailed description
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® as an Active Control in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease This study includes the following 3 sub-studies: 12-hour Pulmonary Function Test (PFT), Pharmacokinetic (PK) Profile, and Hypothalamic-pituitary-adrenal Axis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BGF MDI 320/14.4/9.6 μg | Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler \[MDI\]) |
| DRUG | GFF MDI (PT003) 14.4/9.6 μg | Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI) |
| DRUG | BFF MDI (PT009) 320/9.6 μg | Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI) |
| DRUG | Symbicort® Turbuhaler® (TBH) Inhalation Powder |
Timeline
- Start date
- 2015-08-10
- Primary completion
- 2018-01-05
- Completion
- 2018-01-05
- First posted
- 2015-07-14
- Last updated
- 2020-12-24
- Results posted
- 2020-12-24
Locations
190 sites across 4 countries: United States, Canada, China, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02497001. Inclusion in this directory is not an endorsement.