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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03256552
• Other study ID #: PT001004
• Status: Completed
• Phase: Phase 2
• First received: August 17, 2017
• Last updated: December 22, 2017
• Start date: January 28, 2015
• Est. completion date: September 5, 2015

Study information

• Verified date: December 2017
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: September 5, 2015
• Est. primary completion date: September 5, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Glycopyrronium MDI 28.8 micrograms
Glycopyrronium MDI 28.8 micrograms
• Glycopyrronium MDI 14.4 micrograms
Glycopyrronium MDI 14.4 micrograms
• Glycopyrronium MDI 7.2 micrograms
Glycopyrronium MDI 7.2 micrograms
• Placebo MDI
Placebo Inhalation Aerosol

Locations

Country	Name	City	State
Japan	Pearl Investigative Site	Ako-shi	Hyogo-Ken
Japan	Pearl Investigative Site	Chuo-ku	Tokyo-To
Japan	Pearl Investigative Site	Fukuoka-shi	Fukuoka-Ken
Japan	Pearl Investigative Site	Hamamatsu-shi	Shizuoka-Ken
Japan	Pearl Investigative Site	Himeji-shi	Hyogo
Japan	Pearl Investigative Site	Iizuka-shi	Fukuoka-Ken
Japan	Pearl Investigative Site	Kakogawa-shi	Hyogo-Ken
Japan	Pearl Investigative Site	Kasaoka-shi	Okayama-Ken
Japan	Pearl Investigative Site	Kawasaki-shi	Kanagawa-Ken
Japan	Pearl Investigative Site	Kishiwada-shi	Osaka-Fu
Japan	Pearl Investigative Site	Kobe-Shi	Hyogo-Ken
Japan	Pearl Investigative Site	Kyoto-shi	Kyoto-Fu
Japan	Pearl Investigative Site	Mizunami-shi	Gifu-Ken
Japan	Pearl Investigative Site	Naka-gun	Ibaraki-Ken
Japan	Pearl Investigative Site	Nishinomiya-shi	Hyogo-Ken
Japan	Pearl Investigative Site	Osaka-shi	Osaka-Fu
Japan	Pearl Investigative Site	Sapporo-shi	Hokkaido
Japan	Pearl Investigative Site	Toshima-ku	Tokyo-To

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morning Pre-dose Trough FEV1	Change from Baseline in Morning Pre-dose Trough FEV1	Baseline, Day 8
Secondary	FEV1 AUC0-2	Change from Baseline in FEV1 AUC0-2 normalized for length of follow-up. FEV1 was measured at 15 min, 30 min, 1 hour, and 2 hours post dose.	Day 1 and Day 8
Secondary	Peak Change in FEV1	Peak Change from Baseline in FEV1	Day 1 and Day 8
Secondary	FVC AUC0-2	Change from Baseline in FVC AUC0-2 on Day 8 normalized for length of follow-up. FVC was measured at 15 min, 30 min, 1 hour, and 2 hours post dose.	Baseline, Day 8