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

NCT ID: NCT03256552

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-28
• Study Completion Date: 2015-09-05

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

GP MDI 28.8 micrograms

Glycopyrronium Metered Dose Inhaler 28.8 micrograms

Group Type: ACTIVE_COMPARATOR

Glycopyrronium MDI 28.8 micrograms

Intervention Type: DRUG

Glycopyrronium MDI 28.8 micrograms

GP MDI 14.4 micrograms

Glycopyrronium Metered Dose Inhaler 14.4 micrograms

Group Type: ACTIVE_COMPARATOR

Glycopyrronium MDI 14.4 micrograms

Intervention Type: DRUG

Glycopyrronium MDI 14.4 micrograms

GP MDI 7.2 micrograms

Glycopyrronium Metered Dose Inhaler 7.2 micrograms

Group Type: ACTIVE_COMPARATOR

Glycopyrronium MDI 7.2 micrograms

Intervention Type: DRUG

Glycopyrronium MDI 7.2 micrograms

Placebo MDI

Placebo Inhalation Aerosol

Group Type: PLACEBO_COMPARATOR

Placebo MDI

Intervention Type: DRUG

Placebo Inhalation Aerosol

Interventions

Glycopyrronium MDI 28.8 micrograms

Glycopyrronium MDI 28.8 micrograms

Intervention Type: DRUG

Glycopyrronium MDI 14.4 micrograms

Glycopyrronium MDI 14.4 micrograms

Intervention Type: DRUG

Glycopyrronium MDI 7.2 micrograms

Glycopyrronium MDI 7.2 micrograms

Intervention Type: DRUG

Placebo MDI

Placebo Inhalation Aerosol

Intervention Type: DRUG

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pearl Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pearl Investigative Site

Fukuoka, Fukuoka, Japan

Pearl Investigative Site

Iizuka-shi, Fukuoka, Japan

Pearl Investigative Site

Mizunami-shi, Gifu, Japan

Pearl Investigative Site

Sapporo, Hokkaido, Japan

Pearl Investigative Site

Ako-shi, Hyōgo, Japan

Pearl Investigative Site

Himeji-shi, Hyōgo, Japan

Pearl Investigative Site

Kakogawa-shi, Hyōgo, Japan

Pearl Investigative Site

Kobe, Hyōgo, Japan

Pearl Investigative Site

Nishinomiya-shi, Hyōgo, Japan

Pearl Investigative Site

Naka-gun, Ibaraki, Japan

Pearl Investigative Site

Kawasaki-shi, Kanagawa, Japan

Pearl Investigative Site

Kyoto, Kyoto, Japan

Pearl Investigative Site

Kasaoka-shi, Okayama-ken, Japan

Pearl Investigative Site

Kishiwada-shi, Osaka, Japan

Pearl Investigative Site

Osaka, Osaka, Japan

Pearl Investigative Site

Hamamatsu, Shizuoka, Japan

Pearl Investigative Site

Chūōku, Tokyo-To, Japan

Pearl Investigative Site

Toshima-ku, Tokyo-To, Japan

Countries

Japan

References

Fukushima Y, Nakatani Y, Ide Y, Sekino H, St Rose E, Siddiqui S, Maes A, Reisner C. Randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of three doses of co-suspension delivery technology glycopyrronium MDI in Japanese patients with moderate-to-severe COPD. Int J Chron Obstruct Pulmon Dis. 2018 Apr 13;13:1187-1194. doi: 10.2147/COPD.S159246. eCollection 2018.

Reference Type: DERIVED

PMID: 29695902 (View on PubMed)

Other Identifiers

PT001004

Identifier Type: -

Identifier Source: org_study_id