Status:
COMPLETED
Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD
Lead Sponsor:
Pearl Therapeutics, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
The overall objective of this study was to assess the efficacy and safety of GP MDI relative to placebo in Japanese subjects with moderate to severe COPD. Each subject received the 4 separate study tr...
Detailed Description
This was a randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center study to assess the efficacy and safety of 3 doses of GP MDI (28.8...
Eligibility Criteria
Inclusion
- Clinical history of COPD with a moderate to severe classification
- Current and former smokers with a history of at least 10 pack-years of cigarette smoking.
- Post-bronchodilator FEV1 must be ≥30% and \<80% predicted normal value-
Exclusion
- Pregnancy
- Primary asthma diagnosis; Poorly controlled COPD defined as acute worsening of COPD that required treatment with corticosteroids or antibiotics in the 6-week interval prior to Screening or between Screening and Visit 2;
- Clinically significant abnormal ECG
- Other active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, and uncontrolled sleep apnea; Cancer that was not in complete remission for at least 5 years;
- Diagnosis of angle closure glaucoma
- A documented myocardial infarction within 1 year of Screening.
Key Trial Info
Start Date :
January 28 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2015
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT03256552
Start Date
January 28 2015
End Date
September 5 2015
Last Update
January 23 2018
Active Locations (18)
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1
Pearl Investigative Site
Fukuoka, Fukuoka, Japan
2
Pearl Investigative Site
Iizuka-shi, Fukuoka, Japan
3
Pearl Investigative Site
Mizunami-shi, Gifu, Japan
4
Pearl Investigative Site
Sapporo, Hokkaido, Japan