Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 2 study, sponsored by Pearl Therapeutics.
NCT02196077 is a Phase 2 study that has completed, run by Pearl Therapeutics. The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change from Baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12)
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 |
What the finished NCT02196077 record still lists
NCT02196077 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 5 interventions - of which BFF MDI 320/9.6 μg is the first listed.
NCT02196077 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02196077's enrollment target sits among peer trials
180 365th of 2000 higher than 1,610 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
- NCT01558804 · 180 participants
GRoup A StrePtococcus
- NCT02932176 · 180 participants
Machine Learning for Handheld Vascular Studies
- NCT03384563 · 180 participants · Phase 4
Effect of Dexmedetomidine on the Minimum Alveolar Concentration of Sevoflurane
- NCT03423628 · 180 participants · Phase 1
A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI