A Phase 2 interventional study of Glycopyrronium MDI 28.8 micrograms and Glycopyrronium MDI 14.4 micrograms in Chronic Obstructive Pulmonary Disease, sponsored by Pearl Therapeutics, Inc.. Completed at 18 sites in Japan. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Pearl Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
-Post-bronchodilator FEV1 must be ≥30% and \<80% predicted normal value-
Exclusion Criteria:
Glycopyrronium Metered Dose Inhaler 28.8 micrograms
Drug: Glycopyrronium MDI 28.8 micrograms
Glycopyrronium Metered Dose Inhaler 14.4 micrograms
Drug: Glycopyrronium MDI 14.4 micrograms
Glycopyrronium Metered Dose Inhaler 7.2 micrograms
Drug: Glycopyrronium MDI 7.2 micrograms
Placebo Inhalation Aerosol
Drug: Placebo MDI
Glycopyrronium MDI 28.8 micrograms
Glycopyrronium MDI 14.4 micrograms
Glycopyrronium MDI 7.2 micrograms
Placebo Inhalation Aerosol
Morning Pre-dose Trough FEV1
Change from Baseline in Morning Pre-dose Trough FEV1
Time frame: Baseline, Day 8
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.
Time frame: Day 1 and Day 8
Peak Change in FEV1
Peak Change from Baseline in FEV1
Time frame: 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.
Time frame: Baseline, Day 8
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.
| Milestone | Overall Study |
|---|---|
| Started | 66 |
| Gp mdi 28.8 µg | 61 |
| Gp mdi 14.4 µg | 63 |
| Gp mdi 7.2 µg | 62 |
| Placebo mdi | 65 |
| Completed | 61 |
| Not completed | 5 |
| Withdrew: Protocol violation | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Adverse event | 1 |
| Withdrew: Withdrawal by subject | 2 |
Change from Baseline in Morning Pre-dose Trough FEV1
| Liters | GP MDI 28.8 µg | GP MDI 14.4 µg | GP MDI 7.2 µg | Placebo MDI |
|---|---|---|---|---|
| Morning Pre-dose Trough FEV1 | 0.101 (0.068 to 0.134) | 0.098 (0.066 to 0.131) | 0.077 (0.045 to 0.110) | -0.031 (-0.064 to 0.002) |
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.
| Liters | GP MDI 28.8 µg | GP MDI 14.4 µg | GP MDI 7.2 µg | Placebo MDI |
|---|---|---|---|---|
| Day 1 | 0.176 (0.146 to 0.205) | 0.140 (0.111 to 0.170) | 0.127 (0.098 to 0.157) | 0.043 (0.014 to 0.073) |
| Day 8 | 0.194 (0.157 to 0.230) | 0.199 (0.162 to 0.236) | 0.170 (0.133 to 0.206) | 0.019 (-0.018 to 0.055) |
Peak Change from Baseline in FEV1
| Liters | GP MDI 28.8 µg | GP MDI 14.4 µg | GP MDI 7.2 µg | Placebo MDI |
|---|---|---|---|---|
| Day 1 | 0.254 (0.219 to 0.289) | 0.212 (0.177 to 0.247) | 0.192 (0.157 to 0.227) | 0.104 (0.069 to 0.139) |
| Day 8 | 0.260 (0.219 to 0.301) | 0.265 (0.224 to 0.306) | 0.238 (0.197 to 0.279) | 0.082 (0.041 to 0.124) |
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.
| Liters | GP MDI 28.8 µg | GP MDI 14.4 µg | GP MDI 7.2 µg | Placebo MDI |
|---|---|---|---|---|
| FVC AUC0-2 | 0.273 (0.207 to 0.339) | 0.265 (0.199 to 0.331) | 0.223 (0.157 to 0.288) | 0.047 (-0.019 to 0.113) |
Collected over 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.. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GP MDI 28.8 µg | — | 0/61 (0%) | 2/61 (3.3%) |
| GP MDI 14.4 µg | — | 0/63 (0%) | 2/63 (3.2%) |
| GP MDI 7.2 µg | — | 0/62 (0%) | 1/62 (1.6%) |
| Placebo MDI | — | 1/65 (1.5%) | 1/65 (1.5%) |
| Event | GP MDI 28.8 µg | GP MDI 14.4 µg | GP MDI 7.2 µg | Placebo MDI |
|---|---|---|---|---|
| PneumoniaInfections and infestations | 0/61 | 0/63 | 0/62 | 1/65 |
| Chronic Obstructive Pulmonary DiseaseRespiratory, thoracic and mediastinal disorders | 0/61 | 0/63 | 0/62 | 1/65 |
| Event | GP MDI 28.8 µg | GP MDI 14.4 µg | GP MDI 7.2 µg | Placebo MDI |
|---|---|---|---|---|
| RashSkin and subcutaneous tissue disorders | 2/61 | 0/63 | 0/62 | 0/65 |
| NasopharyngitisInfections and infestations | 0/61 | 2/63 | 1/62 | 1/65 |
MITT Population defined as all subjects who received treatment and had post-treatment efficacy data from at least two treatment periods.
| Age, Continuous(Years) | All Subjects |
|---|---|
| Mean | 67.5 ± 7.0 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 3 |
| Male | 59 |
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pearl Therapeutics, Inc.