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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

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

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080224022
Enrollment
Unknown
Registered
2018-08-24
Start date
2018-08-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

investigational material(s) Generic name etc : Drug: Glycopyrronium MDI 28.8 micrograms, Drug: Glycopyrronium MDI 14.4 micrograms, Drug: Glycopyrronium MDI 7.2 micrograms INN of investigational mate

Sponsors

Pearl Therapeutics, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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% or more and <80% predicted normal value

Exclusion criteria

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026