10 completed. 5 Phase 2, 3 Phase 3, 1 Phase 1, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 5 | Completed 5 |
| Phase 3 | 3 | Completed 3 |
| Phase 1 | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Clinical Study to Investigate if a Single Dose of an Approved Drug Product (Glycopyrrolate Inhalation Solution) Reduces Trapped Air in the Lungs of Participants With Chronic Obstructive Pulmonary Disease. Glyocopyrrolate Inhalation Solution administered by Magnair, Placebo administered by Magnair - Chronic Obstructive Pulmonary Disease (COPD) | Phase 4 | Completed | Sunovion Respiratory Development Inc. | 44 | 2019-11-07 | 2021-05-10 |
| Study to Determine the Amount of Glycopyrrolate Absorbed in the Lungs After Taking the Medicine With a eFlow Nebulizer and Seebri® Breezhaler® With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD). SUN-101 via eFlow nebulizer, SUN-101 via eFlow nebulizer with activated charcoal, Seebri® Breezhaler® - COPD | Phase 1 | Completed | Sunovion Respiratory Development Inc. | 30 | 2015-10-01 | 2018-10-25 |
| Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD SUN-101 50 mcg BID eFlow (CS) nebulizer, SUN-101 25 mcg BID eFlow (CS) nebulizer, Placebo BID eFlow Closed System (CS) nebulizer - COPD | Phase 3 | Completed | Sunovion Respiratory Development Inc. | 653 | 2015-02-01 | 2018-03-22 |
| Efficacy and Safety Trial of 12 Weeks of Treatment With Nebulized SUN-101 in Patients With COPD (GOLDEN-4) SUN-101 50 mcg BID eFlow (CS) nebulizer, SUN-101 25 mcg BID eFlow (CS) nebulizer, Placebo eFlow (CS) nebulizer - COPD, Chronic Obstructive Pulmonary Disease | Phase 3 | Completed | Sunovion Respiratory Development Inc. | 641 | 2015-02-01 | 2018-03-13 |
| A Long-Term Safety Trial of Treatment With Nebulized SUN-101 in Patients With COPD SUN-101 50 mcg BID eFlow (CS) nebulizer, Spiriva® 18 mcg QD Handihaler - Chronic Obstructive Pulmonary Disease (COPD) | Phase 3 | Completed | Sunovion Respiratory Development Inc. | 1087 | 2014-10-01 | 2018-03-13 |
| A Dose-Range Finding Study of SUN-101 in Subjects With Moderate to Severe COPD Placebo, SUN101 3 mcg, SUN-101 6.25 mcg - COPD | Phase 2 | Completed | Sunovion Respiratory Development Inc. | 96 | 2014-01-01 | 2018-04-10 |
| A Study of the Efficacy and Safety of EP-101 ( (SUN101) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease Placebo, EP-101 12.5 mcg, EP-101 25 mcg - COPD | Phase 2 | Completed | Sunovion Respiratory Development Inc. | 275 | 2012-10-01 | 2018-03-08 |
| Study to Investigate the Dose Response, Safety and Efficacy of Nebulized EP-101(SUN101) in Patients With Chronic Obstructive Pulmonary Disease (COPD): GOLDEN-1 Study EP-101 via nebulizer (eFlow®) 25 ug, EP-101 via nebulizer (eFlow®) 50 ug, EP-101 via nebulizer (eFlow®) 100 ug - Chronic Obstructive Pulmonary Disease | Phase 2 | Completed | Sunovion Respiratory Development Inc. | 140 | 2011-08-01 | 2018-05-09 |
| Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD) Glycopyrrolate Inhalation Solution12.5μg, Glycopyrrolate Inhalation Solution 50μg, Glycopyrrolate Inhalation Solution 100μg - Chronic Obstructive Pulmonary Disease | Phase 2 | Completed | Sunovion Respiratory Development Inc. | 42 | 2010-07-01 | 2018-03-12 |
| Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered With an Electronic eFlow Nebulizer System in Patients With Chronic Obstructive Pulmonary Disease (COPD) Glycopyrrolate Inhalation Solution 25mg, Glycopyrrolate Inhalation Solution 75mg, Glycopyrrolate Inhalation Solution 200mg - Chronic Obstructive Pulmonary Disease | Phase 2 | Completed | Sunovion Respiratory Development Inc. | 12 | 2009-05-01 | 2018-04-30 |
Pulmonary Disease, Chronic Obstructive (10) · Bronchitis, Chronic (2) · Emphysema (2)
Nebulizers and Vaporizers (3) · Glycopyrrolate (2) · Tiotropium Bromide (2) · Charcoal (1) · Ipratropium (1) · aclidinium bromide (1)
United States (7) · United Kingdom (2) · Czechia (1) · Hungary (1) · Russia (1)
Ahmet Tutuncu, MD, PhD (2) · Ahmet Tutuncu, M.D., Ph.D. (1)
PMID 30584583, PMID 28838685, PMID 29202767, PMID 30587959, PMID 25243340, PMID 28919143, PMID 31253162, PMID 34232493
2009 (1)