Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 3 study, sponsored by Pearl Therapeutics.
NCT01854645 is a Phase 3 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 2,103 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (172% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24
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 |
What the finished NCT01854645 record still lists
NCT01854645 is an interventional study that assigns participants to a tested intervention. Its 2,103 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (172% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo MDI is the first listed.
NCT01854645 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01854645's enrollment target sits among peer trials
2,103 98th of 2000 higher than 1,903 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05967273 · 2,106 participants · NA
CirrhosisRx CDS System
- NCT04649242 · 2,100 participants · Phase 3
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
- NCT05206331 · 2,100 participants · Phase 4
CEM to Reduce Biopsy Rates for Less Than Highly Suspicious Breast Abnormalities: a Prospective Study
- NCT05270499 · 2,100 participants
Aveir VR Real-World Evidence Post-Approval Study
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia