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NCT01854645 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)
A Phase 3 study, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,103
- Enrollment target
NCT01854645 is a Phase 3 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 2,103 participants.
The verdict
NCT01854645, a Phase 3 study, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,103 participants
- Enrollment target
Study Summary
The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.
Interventions
- DRUG Placebo MDI
- DRUG GFF MDI
- DRUG GP MDI
- DRUG FF MDI
- DRUG Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,103 participants |
| Start Date | 2013-05 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01854645
The ClinicalTrials.gov registry entry for NCT01854645 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 2,103 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 Placebo MDI is the first listed.
NCT01854645 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01854645 about?
NCT01854645 is a clinical study titled "Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)". The overall objective of this study is to assess the efficacy and safety of treatment with PT003 (GFF MDI), PT005 (FF MDI), PT001 (GP MDI), and open-label tiotropium bromide inhalation powder compared with each other and Placebo MDI over 24 weeks in subjects with moderate to very severe COPD.
What is the current status of trial NCT01854645?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,103 participants. The study started on 2013-05. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01854645?
The interventions under investigation include: Placebo MDI (DRUG), GFF MDI (DRUG), GP MDI (DRUG), FF MDI (DRUG), Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®) (DRUG).
Who is sponsoring clinical trial NCT01854645?
This trial is sponsored by Pearl Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
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