Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control
Verified date | October 2013 |
Source | Pearl Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD
Status | Completed |
Enrollment | 159 |
Est. completion date | October 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
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 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Pearl Investigative Site | Cincinnati | Ohio |
United States | Pearl Investigative Site | Clearwater | Florida |
United States | Pearl Investigative Site | Clearwater | Florida |
United States | Pearl Investigative Site | Fridley | Minnesota |
United States | Pearl Investigative Site | Glendale | Arizona |
United States | Pearl Investigative Site | Lafayette | Louisiana |
United States | Pearl Investigative Site | Medford | Oregon |
United States | Pearl Investigative Site | Medford | Oregon |
United States | Pearl Investigative Site | Morgantown | West Virginia |
United States | Pearl Investigative Site | North Dartmouth | Massachusetts |
United States | Pearl Investigative Site | Pensacola | Florida |
United States | Pearl Investigative Site | Rancho Mirage | California |
United States | Pearl Investigative Site | Rock Hill | South Carolina |
United States | Pearl Investigative Site | San Antonio | Texas |
United States | Pearl Investigative Site | Spartanburg | South Carolina |
United States | Pearl Investigative Site | St. Louis | Missouri |
United States | Pearl Investigative Site | Summit | New Jersey |
United States | Pearl Investigative Site | Waterbury | Connecticut |
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 relative to baseline following chronic dosing (1 week). | 7 days | No |
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