Study to Assess the Efficacy and Safety of Three Doses of PT001 in Japanese Subjects With Moderate to Severe COPD
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
1 other identifier
interventional
66
1 country
18
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 chronic-obstructive-pulmonary-disease
Started Jan 2015
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2015
CompletedFirst Submitted
Initial submission to the registry
August 17, 2017
CompletedFirst Posted
Study publicly available on registry
August 22, 2017
CompletedResults Posted
Study results publicly available
January 23, 2018
CompletedJanuary 23, 2018
December 1, 2017
7 months
August 17, 2017
November 13, 2017
December 22, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Morning Pre-dose Trough FEV1
Change from Baseline in Morning Pre-dose Trough FEV1
Baseline, Day 8
Secondary Outcomes (3)
FEV1 AUC0-2
Day 1 and Day 8
Peak Change in FEV1
Day 1 and Day 8
FVC AUC0-2
Baseline, Day 8
Study Arms (4)
GP MDI 28.8 micrograms
ACTIVE COMPARATORGlycopyrronium Metered Dose Inhaler 28.8 micrograms
GP MDI 14.4 micrograms
ACTIVE COMPARATORGlycopyrronium Metered Dose Inhaler 14.4 micrograms
GP MDI 7.2 micrograms
ACTIVE COMPARATORGlycopyrronium Metered Dose Inhaler 7.2 micrograms
Placebo MDI
PLACEBO COMPARATORPlacebo Inhalation Aerosol
Interventions
Eligibility Criteria
You may qualify if:
- 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-
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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
Related Publications (1)
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.
PMID: 29695902DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Colin Reisner, MD, FCCP, FAAAAI
- Organization
- Pearl Therapeutics, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2017
First Posted
August 22, 2017
Study Start
January 28, 2015
Primary Completion
September 5, 2015
Study Completion
September 5, 2015
Last Updated
January 23, 2018
Results First Posted
January 23, 2018
Record last verified: 2017-12