Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GP MDI 28.8 micrograms | Active Comparator | Glycopyrronium Metered Dose Inhaler 28.8 micrograms |
|
| GP MDI 14.4 micrograms | Active Comparator | Glycopyrronium Metered Dose Inhaler 14.4 micrograms |
|
| GP MDI 7.2 micrograms | Active Comparator | Glycopyrronium Metered Dose Inhaler 7.2 micrograms |
|
| Placebo MDI | Placebo Comparator | Placebo Inhalation Aerosol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrronium MDI 28.8 micrograms | Drug | Glycopyrronium MDI 28.8 micrograms |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Morning Pre-dose Trough FEV1 | Change from Baseline in Morning Pre-dose Trough FEV1 | Baseline, Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Peak Change in FEV1 | Peak Change from Baseline in FEV1 |
Not provided
Inclusion Criteria:
-Post-bronchodilator FEV1 must be ≥30% and <80% predicted normal value-
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pearl Investigative Site | Fukuoka | Fukuoka | Japan | |||
| Pearl Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29695902 | Derived | 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. |
Not provided
Not provided
This was a chronic dosing (7 days), 4-period, 4-treatment, placebo-controlled, crossover study. Each subject was randomized to 1 of 4 sequences. Each sequence included the four treatment groups. By-treatment sequence tabulations of the data were not pre-specified.
Conducted at 20 sites in Japan from January-September 2015. Entire period of study participation per subject was a maximum of 19 weeks. Planned target enrollment of 60 subjects.
| ID | Title | Description |
|---|---|---|
| FG000 | Overall Study | All Subjects Randomized |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
randomized, double-blind, chronic-dosing (7-day), four-period, four-treatment, placebo-controlled, crossover, multi-center
Not provided
Not provided
Not provided
| Glycopyrronium MDI 14.4 micrograms |
| Drug |
Glycopyrronium MDI 14.4 micrograms |
|
| Glycopyrronium MDI 7.2 micrograms | Drug | Glycopyrronium MDI 7.2 micrograms |
|
| Placebo MDI | Drug | Placebo Inhalation Aerosol |
|
| Day 1 and Day 8 |
| 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 |
| 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 |
| GP MDI 28.8 µg | Glycopyrronium Metered Dose Inhaler (MDI) 28.8 µg BID |
|
| GP MDI 14.4 µg | Glycopyrronium Metered Dose Inhaler (MDI) 14.4 µg BID |
|
| GP MDI 7.2 µg | Glycopyrronium Metered Dose Inhaler (MDI) 7.2 µg BID |
|
| Placebo MDI | Placebo Metered Dose Inhaler BID |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | All Subjects in the MITT Population |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Morning Pre-dose Trough FEV1 | Change from Baseline in Morning Pre-dose Trough FEV1 | MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | 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. | MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Day 1 and Day 8 |
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Peak Change in FEV1 | Peak Change from Baseline in FEV1 | MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | 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. | MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods. | Posted | Least Squares Mean | 95% Confidence Interval | Liters | Baseline, Day 8 |
|
|
Adverse events were collected from the time the subject signed consent up to the follow-up visit 7-14 days after last dose of study drug.
Safety population included all participants who received at least one dose of investigational drug and had safety data available; participants were included in safety population according to the investigational drug received
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GP MDI 28.8 µg | Glycopyrronium MDI 28.8 µg | 0 | 61 | 2 | 61 | ||
| EG001 | GP MDI 14.4 µg | Glycopyrronium 14.4 µg | 0 | 63 | 2 | 63 | ||
| EG002 | GP MDI 7.2 µg | Glycopyrronium 7.2 µg | 0 | 62 | 1 | 62 | ||
| EG003 | Placebo MDI | Placebo MDI | 1 | 65 | 1 | 65 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colin Reisner, MD, FCCP, FAAAAI | Pearl Therapeutics, Inc | 650-305-2600 | creisner@pearltherapeutics.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
|
|
|
|
|