Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomized, Double-Blind, Chronic Dosing (7 Days), Three-Period, Six-Treatment, Placebo-Controlled, Incomplete Block, Cross-Over, Multi-Center Study to Assess Efficacy and Safety of Four Doses of PT001 in Patients With Moderate to Severe COPD, Compared With Atrovent® HFA Inhalation Aerosol (Open-Label) as An Active Control
Verified date | May 2018 |
Source | Pearl Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overall objective of this study is to determine an optimal dose and dosing regimen of PT001 MDI for further evaluation in later stage studies.
Status | Completed |
Enrollment | 103 |
Est. completion date | October 1, 2011 |
Est. primary completion date | October 1, 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Key Inclusion Criteria: - Signed written informed consent - 40 - 80 years of age - Clinical history of COPD with airflow limitation that is not fully reversible - Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods - Current/former smokers with at least a 10 pack-year history of cigarette smoking - A measured post- bronchodilator FEV1/FVC ratio of < or = 0.70 - A measured post- bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values - Able to change COPD treatment as required by protocol Key Exclusion Criteria: - Women who are pregnant or lactating - Primary diagnosis of asthma - Alpha-1 antitrypsin deficiency as the cause of COPD - Active pulmonary diseases - Prior lung volume reduction surgery - Abnormal chest X-ray (or CT scan) not due to the presence of COPD - Hospitalized due to poorly controlled COPD within 3 months of Screening - Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy) - Cancer that has not been in complete remission for at least 5 years - Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives Other inclusion/exclusion criteria as defined in the protocol |
Country | Name | City | State |
---|---|---|---|
United States | Pearl Investigative Site | Charlotte | North Carolina |
United States | Pearl Investigative Site | Cherry Hill | New Jersey |
United States | Pearl Investigative Site | Longview | Texas |
United States | Pearl Investigative Site | Medford | Oregon |
United States | Pearl Investigative Site | Panama City | Florida |
United States | Pearl Investigative Site | Richmond | Virginia |
United States | Pearl Investigative Site | Summit | New Jersey |
United States | Pearl Investigative Site | Winter Park | Florida |
Lead Sponsor | Collaborator |
---|---|
Pearl Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FEV1 AUC0-12 | FEV1 AUC0-12 following chronic dosing (1 week), normalized. | Day 7 ( -1 hour, -30 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 5.5 hours, 6.5 hours, 8 hours, 10 hours, 11.5 hours, and 12 hours) | |
Secondary | Peak Change From Baseline in FEV1 on Day 1 | Highest value of FEV1 post-dose minus baseline on Day 1 (baseline-adjusted) | Day 1 | |
Secondary | Time to Onset of Action ( =10% Improvement in FEV1) on Day 1 | Time to onset of action ( =10% improvement in FEV1) | Day 1 (15 min, 30 min, 1 hour, 2 hours) | |
Secondary | Proportion of Subjects Achieving at Least 12% Improvement in FEV1 on Day 1 | Proportion of subjects achieving at least 12% improvement in FEV1 (relative to baseline) | Day 1 | |
Secondary | Peak Change From Baseline in IC on Day 1 | Peak change from baseline in Inspiratory Capacity (IC) on Day 1 (mean of 1 and 2 hours post-dose minus baseline on Day 1) | Day 1 | |
Secondary | Change From Baseline in Morning Pre-dose FEV1 on Day 7 | Change from baseline in morning pre-dose FEV1 | Day 7 | |
Secondary | Peak Change From Baseline in FEV1 on Day 7 | Peak change from baseline in FEV1 | Day 7 | |
Secondary | Peak Change From Baseline in IC on Day 7 | Peak change from baseline in IC | Day 7 | |
Secondary | Change From Baseline in 12-hour Post-dose Trough FEV1 on Day 7 | Change from baseline in 12-hour post-dose trough FEV1 | Day 7 |
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