A Randomized, Double-Blind, Chronic Dosing (7-Day), Four-Period, Four-Treatment, Placebo-Controlled, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Registration Number
- JPRN-jRCT2080224022
- Lead Sponsor
- Pearl Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
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% or more and <80% predicted normal value
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method