Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomized, Double Blind, Chronic Dosing (7 Days), Two Period, Six Treatment, Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Four Doses of PT003 MDI in Patients With Moderate to Severe COPD, Compared With Its Individual Components (PT005 MDI and PT001 MDI) as Active Controls
Verified date | April 2017 |
Source | Pearl Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary objective of this study is to demonstrate efficacy of PT003 MDI relative to its individual components (PT001 MDI and PT005 MDI) in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Status | Completed |
Enrollment | 185 |
Est. completion date | November 2011 |
Est. primary completion date | November 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 | Brooklyn | New York |
United States | Pearl Investigative Site | Charlotte | North Carolina |
United States | Pearl Investigative Site | Cincinnati | Ohio |
United States | Pearl Investigative Site | Clearwater | Florida |
United States | Pearl Investigative Site | Colorado Springs | Colorado |
United States | Pearl Investigative Site | Medford | Oregon |
United States | Pearl Investigative Site | Minneapolis | Minnesota |
United States | Pearl Investigative Site | Pensacola | Florida |
United States | Pearl Investigative Site | Rancho Mirage | California |
United States | Pearl Investigative Site | Spartanburg | South Carolina |
United States | Pearl Investigative Site | Stockbridge | Georgia |
United States | Pearl Investigative Site | Waterbury | Connecticut |
United States | Pearl Investigative Site | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Pearl Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | FEV1 AUC0-12 | Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week). | Day 7 | |
Secondary | Peak Change From Baseline in FEV1 | Peak change from baseline in FEV1 through 2 hours | Day 1 | |
Secondary | Time to Onset of Action | At least 10% improvement in mean FEV1 | Day 1 | |
Secondary | At Least 12% Improvement in FEV1 | Proportion of subjects achieving >=12% improvement in FEV1 relative to baseline | Day 1 | |
Secondary | Peak Change in IC | Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline | Day 1 | |
Secondary | Morning Pre-dose FEV1 | Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7) | Day 7 | |
Secondary | FEV1 Through 6 Hours | Peak change from baseline in FEV1 through 6 hours | Day 7 | |
Secondary | Peak Change From Baseline in IC | Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline) | Day 7 | |
Secondary | Mean Evening Trough FEV1 | Change from baseline in mean evening 12-hour post-dose trough FEV1 | Day 7 |
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