Trials / Completed
CompletedNCT03262012
Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With COPD Compared With Symbicort® Turbohaler®
A Randomized, Double-Blind, Parallel-Group, 28-Week, Chronic-Dosing, Multi-Center, Extension Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) Compared With Symbicort® Turbuhaler® as an Active Control
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 416 (actual)
- Sponsor
- Pearl Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A Randomized, Double-Blind, Parallel Group, 28-Week Chronic Dosing, Multi-Center Long-term Extension Study to Assess the Safety and Efficacy in Japanese Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) compared with Symbicort® Turbohaler®
Detailed description
This is a multicenter, randomized, double-blind, parallel group, chronic dosing, active-controlled, 28-week, safety extension of Study PT010006 to assess the safety and efficacy of BGF MDI, GFF MDI, BFF MDI, and Symbicort TBH as an active control over a 52-week period in Japanese subjects with moderate to very severe COPD who remain symptomatic on maintenance treatment with either an ICS and one or more bronchodilator(s) or two or more maintenance bronchodilators.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BGF MDI (PT010) | Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010 |
| DRUG | GFF MDI (PT003) | Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003 |
| DRUG | BFF MDI (PT009) | Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009 |
| DRUG | Symbicort® Turbohaler® Inhalation Powder | Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler |
Timeline
- Start date
- 2016-08-09
- Primary completion
- 2018-06-15
- Completion
- 2018-06-15
- First posted
- 2017-08-25
- Last updated
- 2020-05-13
- Results posted
- 2020-05-13
Locations
79 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03262012. Inclusion in this directory is not an endorsement.