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

Pearl Therapeutics

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Glycopyrronium MDI 28.8 micrograms; Drug: Placebo MDI; Drug: Glycopyrronium MDI 14.4 micrograms; Drug: Glycopyrronium MDI 7.2 micrograms

Study type: Interventional

Funder types: Industry

Identifiers

NCT03256552

PT001004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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66 participants in 4 patient groups, including a placebo group

GP MDI 28.8 micrograms

Active Comparator group

Description:

Glycopyrronium Metered Dose Inhaler 28.8 micrograms

Treatment:

Drug: Glycopyrronium MDI 28.8 micrograms

GP MDI 14.4 micrograms

Active Comparator group

Description:

Glycopyrronium Metered Dose Inhaler 14.4 micrograms

Treatment:

Drug: Glycopyrronium MDI 14.4 micrograms

GP MDI 7.2 micrograms

Active Comparator group

Description:

Glycopyrronium Metered Dose Inhaler 7.2 micrograms

Treatment:

Drug: Glycopyrronium MDI 7.2 micrograms

Placebo MDI

Placebo Comparator group

Description:

Placebo Inhalation Aerosol

Treatment:

Drug: Placebo MDI