Clinical trial NCT03256552: Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-22
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Morning Pre-dose Trough FEV1
timeFrame: Baseline, Day 8
Secondary outcomes:
measure: FEV1 AUC0-2
timeFrame: Day 1 and Day 8
measure: Peak Change in FEV1
timeFrame: Day 1 and Day 8
measure: FVC AUC0-2
timeFrame: Baseline, Day 8
Other outcomes:
Locations:
city: Fukuoka-shi
country: Japan
facility: Pearl Investigative Site
state: Fukuoka-Ken
city: Iizuka-shi
country: Japan
facility: Pearl Investigative Site
state: Fukuoka-Ken
city: Mizunami-shi
country: Japan
facility: Pearl Investigative Site
state: Gifu-Ken
city: Sapporo-shi
country: Japan
facility: Pearl Investigative Site
state: Hokkaido
city: Ako-shi
country: Japan
facility: Pearl Investigative Site
state: Hyogo-Ken
city: Kakogawa-shi
country: Japan
facility: Pearl Investigative Site
state: Hyogo-Ken
city: Kobe-Shi
country: Japan
facility: Pearl Investigative Site
state: Hyogo-Ken
city: Nishinomiya-shi
country: Japan
facility: Pearl Investigative Site
state: Hyogo-Ken
city: Himeji-shi
country: Japan
facility: Pearl Investigative Site
state: Hyogo
city: Naka-gun
country: Japan
facility: Pearl Investigative Site
state: Ibaraki-Ken
city: Kawasaki-shi
country: Japan
facility: Pearl Investigative Site
state: Kanagawa-Ken
city: Kyoto-shi
country: Japan
facility: Pearl Investigative Site
state: Kyoto-Fu
city: Kasaoka-shi
country: Japan
facility: Pearl Investigative Site
state: Okayama-Ken
city: Kishiwada-shi
country: Japan
facility: Pearl Investigative Site
state: Osaka-Fu
city: Osaka-shi
country: Japan
facility: Pearl Investigative Site
state: Osaka-Fu
city: Hamamatsu-shi
country: Japan
facility: Pearl Investigative Site
state: Shizuoka-Ken
city: Chuo-ku
country: Japan
facility: Pearl Investigative Site
state: Tokyo-To
city: Toshima-ku
country: Japan
facility: Pearl Investigative Site
state: Tokyo-To
Study officials:
References:
citation: 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.