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

Pearl Therapeutics, Inc.1 site in 1 country66 target enrollmentJanuary 28, 2015

ConditionsChronic Obstructive Pulmonary Disease

InterventionsGlycopyrronium MDI 28.8 micrograms Glycopyrronium MDI 14.4 micrograms Glycopyrronium MDI 7.2 micrograms Placebo MDI

DrugsGlycopyrronium MDI 28.8 micrograms Glycopyrronium MDI 14.4 micrograms Glycopyrronium MDI 7.2 micrograms Placebo MDI

Overview

Phase: Phase 2
Intervention: Glycopyrronium MDI 28.8 micrograms
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Pearl Therapeutics, Inc.
Enrollment: 66
Locations: 1
Primary Endpoint: Morning Pre-dose Trough FEV1
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

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, 14.4, and 7.2 μg ex-actuator, BID) in Japanese subjects with moderate to severe COPD. Subjects who met the entry criteria had their maintenance therapy for COPD adjusted, as specified in the protocol. To allow for an adequate washout of previous maintenance medications, subjects underwent a washout period of at least 7 days, but not greater than 28 days duration prior to returning to the clinic for Visit 2 (Randomization Visit; Day 1 of Treatment Period 1). The 4 study treatments were GP MDI 28.8, 14.4, and 7.2 μg ex-actuator, and Placebo MDI BID. Subjects were randomly assigned to 1 of the following 4 treatment sequences (ABCD, BDAC, CADB, DCBA) in a 1:1:1:1 ratio using an Interactive Web Response System where each letter represented 1 of the 4 treatments included in the study by random assignment. Subjects were to complete 7 days of dosing in each of the 4 Treatment Periods, with each Treatment Period separated by a washout period of 5 to 21 days.

Registry

clinicaltrials.gov

Start Date

January 28, 2015

End Date

September 5, 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pearl Therapeutics, Inc.

Responsible Party

Sponsor

Eligibility 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.