Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD

• Status: Completed
• Trial end date: 2015-09-05
• Target enrollment: 0
• Participant gender: All

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 treatments, scheduled as four, 7-day, treatment periods for a total treatment duration of 28 days.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pearl Therapeutics, Inc.
• Treatments: Glycopyrrolate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.