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)
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ClinicalTrials.gov Identifier: NCT01085045 |
Recruitment Status
:
Completed
First Posted
: March 11, 2010
Results First Posted
: April 26, 2017
Last Update Posted
: April 26, 2017
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Sponsor:
Pearl Therapeutics, Inc.
Information provided by (Responsible Party):
Pearl Therapeutics, Inc.
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Tracking Information | ||||
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First Submitted Date ICMJE | March 9, 2010 | |||
First Posted Date ICMJE | March 11, 2010 | |||
Results First Submitted Date | May 24, 2016 | |||
Results First Posted Date | April 26, 2017 | |||
Last Update Posted Date | April 26, 2017 | |||
Study Start Date ICMJE | March 2010 | |||
Actual Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
FEV1 AUC 0-12 on Day 7 [ Time Frame: "Pre-dose, 15 minutes, 30 minutes, 1, 2, 4, 6, 8, 10, 11.5, and 12 hours post-dose on Day 7 ] Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 (normalized) relative to baseline FEV1 following 7-day dose administration
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Original Primary Outcome Measures ICMJE |
Change in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline [ Time Frame: Day 7 ] Day 7 time points for FEV1 are measured over 12 hrs
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Change History | Complete list of historical versions of study NCT01085045 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | 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) | |||
Official Title ICMJE | A Randomized, Double-Blind (Test Products and Placebo), Chronic Dosing (7 Days), Four-Period, Eight-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Two Doses of PT003, Two Doses of PT005 and One Dose of PT001 in Patients With Moderate to Very Severe COPD, Compared With Foradil® Aerolizer® (12 μg, Open-Label) and Spiriva® Handihaler® (18 μg, Open-Label) as Active Controls | |||
Brief 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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Obstructive Pulmonary Disease | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
118 | |||
Original Estimated Enrollment ICMJE |
84 | |||
Actual Study Completion Date | November 2010 | |||
Actual Primary Completion Date | November 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria may apply |
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Sex/Gender |
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Ages | 40 Years to 80 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Australia, New Zealand, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01085045 | |||
Other Study ID Numbers ICMJE | PT0031002 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pearl Therapeutics, Inc. | |||
Study Sponsor ICMJE | Pearl Therapeutics, Inc. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pearl Therapeutics, Inc. | |||
Verification Date | March 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |