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NCT02196077 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
NCT02196077 is a Phase 2 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 180 participants.
The verdict
NCT02196077, a Phase 2 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
Study Summary
This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The overall objective is to demonstrate that the combination of budesonide (BD; PT008) and formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.
Interventions
- DRUG BFF MDI 320/9.6 μg
- DRUG BFF MDI 160/9.6 μg
- DRUG FF MDI 9.6 μg
- DRUG BD MDI 320 μg
- DRUG BFF MDI 80/9.6 μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2014-08-01 |
| Est. Completion | 2015-03-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02196077
The ClinicalTrials.gov registry entry for NCT02196077 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pearl Therapeutics, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which BFF MDI 320/9.6 μg is the first listed.
NCT02196077 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02196077 about?
NCT02196077 is a clinical study titled "Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)". This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The overall objective is to demonstrate that the combination of budesonide (BD; PT008) and formoterol fumarate (FF; PT005...
What is the current status of trial NCT02196077?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2014-08-01. Estimated completion is 2015-03-01.
What interventions are being tested in trial NCT02196077?
The interventions under investigation include: BFF MDI 320/9.6 μg (DRUG), BFF MDI 160/9.6 μg (DRUG), FF MDI 9.6 μg (DRUG), BD MDI 320 μg (DRUG), BFF MDI 80/9.6 μg (DRUG).
Who is sponsoring clinical trial NCT02196077?
This trial is sponsored by Pearl Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
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