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. (part of AstraZeneca) · Phase 2, Interventional, and Treatment
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Among 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca — 14 open to participants now, 15 under way, 4 of them phase 3. Pulmonary Disease, Chronic Obstructive · AstraZeneca.
Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, this one is the 128th largest by enrollment of the 194 interventional ones that give a count, is one of 19 that started in 2015, is one of 54 in phase 2, and was the 207th registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →14 of the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Korea, Republic of
AstraZeneca · Sites in France
Ages 18–99
AstraZeneca · Sites in India
Ages 18+
AstraZeneca · Sites in Argentina, Egypt, Mexico and 4 more countries
Ages 18+
AstraZeneca · Sites in Argentina, Colombia, Egypt and 9 more countries
Ages 30–80
By country, each count listing its studies:
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 89 take healthy volunteers.
This study: 40 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
284 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 57 · Phase 3 77 · Phase 4 19
First in 1999; this study’s year is marked. 19 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 66 is close to the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 137 across the 194 interventional studies, 976 across the 89 observational. Of the 264 that completed or were terminated, 127 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
This study is registered under Pearl Therapeutics, Inc., one of the names counted as AstraZeneca. Under that name alone:
Pearl Therapeutics, Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 15 (94%) have results posted.
9 of the studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06712563AstraZenecaPooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting | 2026-12-14 |
| NCT07245576AstraZenecaAssess Accuracy of Primary Care Asthma and COPD Diagnosis Using Oscillometry and FeNO vs Specialist Diagnosis | 2027-04-30 |
| NCT07315958AstraZenecaStudy for Assessing the Prevalence of Airflow Limitation in Outpatients With History of Smoking Attending Cardiology Clinics | 2027-04-30 |
| NCT07073950AstraZenecaA Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation | 2027-05-31 |
| NCT07307781AstraZenecaStudy of Patient With Frequent Exacerbations in Moscow | 2027-06-25 |
Add all 9 to your calendar (.ics) → With an account.
Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
-Post-bronchodilator must be ≥30% and \<80% predicted normal value-
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 |
Ran from Jan 2015 to primary completion in Sep 2015, 7 months.
Results were first posted in Jan 2018, 2 years 4 months after primary completion.
Of 118 industry-sponsored phase 2 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 20. This study's 7 months is below that.
Counting every sponsor, half of 165 studies reached it within 17 months; a quarter within 10 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →