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NCT01085045 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
A Phase 2 study of Chronic Obstructive Pulmonary Disease, sponsored by Pearl Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
- 16
- Study locations
NCT01085045: Completed Phase 2 study of Chronic Obstructive Pulmonary Disease, sponsored by Pearl Therapeutics.
NCT01085045 is a Phase 2 study of Chronic Obstructive Pulmonary Disease that has completed, run by Pearl Therapeutics. The registered enrollment target is 118 participants, below the 1,753-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (93% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01085045, a Phase 2 study of Chronic Obstructive Pulmonary Disease, has completed, sponsored by Pearl Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
- 16
- Study locations
Study Summary
The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.
Primary Outcome
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration
Conditions Studied
Interventions
- DRUG PT003 MDI
- DRUG PT005 MDI
- DRUG Placebo MDI
- DRUG Tiotropium bromide 18 μg (Spiriva Handihaler®)
- DRUG Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Study Locations (16)
New South Wales
- Austrials - Caringbah
- Woolcock - Glebe
- Austrials - Hornsby
Queensland
- Austrials - Auchenflower
- Q-Pharm - Herston
Auckland
- Greenlane Clinical Centre - Epsom
- NZ Respiratory & Sleep Institute - Greenlane East
Florida
- Clinical Research of West Florida, Inc. - Clearwater
North Carolina
- American Health Research - Charlotte
Oregon
- Clinical Research Institute of Southern Oregon, PC - Medford
South Carolina
- Spartanburg Medical Research - Spartanburg
South Australia
- Respiratory Research Foundation - Burnside War Memorial Hospital - Adelaide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-11 |
| Phase | Phase 2 |
What the finished NCT01085045 record still lists
NCT01085045 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 1,753-participant average among 86 other Chronic Obstructive Pulmonary Disease trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Chronic Obstructive Pulmonary Disease appearing as the primary indexed condition, and to 5 interventions - of which PT003 MDI is the first listed.
NCT01085045 lists 16 locations in 12 states (New South Wales, Queensland, Auckland).
Frequently Asked Questions
What is clinical trial NCT01085045 about?
NCT01085045 is a clinical study titled "Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)". The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of...
What is the current status of trial NCT01085045?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2010-03. Estimated completion is 2010-11.
What conditions does trial NCT01085045 study?
This clinical trial studies the following conditions: Chronic Obstructive Pulmonary Disease.
What interventions are being tested in trial NCT01085045?
The interventions under investigation include: PT003 MDI (DRUG), PT005 MDI (DRUG), Placebo MDI (DRUG), Tiotropium bromide 18 μg (Spiriva Handihaler®) (DRUG), Formoterol Fumarate 12 μg (Foradil® Aerolizer®) (DRUG).
Who is sponsoring clinical trial NCT01085045?
This trial is sponsored by Pearl Therapeutics, which has 31 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01085045 being conducted?
This trial has 16 study locations across Florida, North Carolina, Oregon, South Carolina, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Obstructive Pulmonary Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01085045's enrollment target sits among peer trials
118 49th of 86 higher than 38 of 86 other Chronic Obstructive Pulmonary Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Obstructive Pulmonary Disease 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.
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