39 completed, 1 unknown, 1 withdrawn. 20 Phase 3, 10 Phase 4, 8 Phase 2, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 20 | Completed 20 |
| Phase 4 | 10 | Completed 8, Unknown 1, Withdrawn 1 |
| Phase 2 | 8 | Completed 8 |
| Phase 1 | 1 | Completed 1 |
Follow aclidinium bromide: new trials by email Literature Review of aclidinium bromide trials Research Report on aclidinium bromide
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 Phase I, Open-Label, Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Aclidinium Bromide in Healthy Chinese Participants Aclidinium Bromide 400 μg - Healthy Volunteers | Phase 1 | Completed | AstraZeneca | 20 | 2021-10-14 | 2023-12-11 |
| To Evaluate Effectiveness of Aclidinium Bromide/Formoterol Fumarate Dihydrate in Chronic Obstructive Pulmonary Disease Aclidinium bromide/formoterol fumarate combination, Standard of Care - Chronic Obstructive Pulmonary Disease | Phase 4 | Withdrawn | AstraZeneca | 2017-12-04 | 2017-07-02 | |
| Pharmacokinetics, Safety and Tolerability of Twice-Daily Aclidinium Bromide/Formoterol Fumarate Fixed Dose Combination in Chinese Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Aclidinium Bromide/Formoterol Fumarate 400/12μg BID - Pulmonary Disease, Chronic Obstructive | Phase 2 | Completed | AstraZeneca | 20 | 2017-11-23 | 2019-07-22 |
| The Effect of Twice Daily vs. Once Daily Bronchodilation on Hyperinflation in COPD Patients During 24 Hours. Tiotropium 'Respimat' 5 mcg, Aclidinium Bromide/Formoterol Fumarate 340/12 mcg - Chronic Obstructive Airway Disease | Phase 4 | Unknown | Maastricht University Medical Center | 49 | 2017-07-07 | 2020-03-10 |
| The Effects of Inhaled Aclidinium Bromide/Formoterol Fumarate on Inspiratory Pleural Pressures in Smokers Aclidinium bromide/formoterol fumarate dihydrate, Placebo - Smoking | Phase 3 | Completed | McGill University Health Centre/Research Institute of the McGill University Health Centre | 43 | 2017-05-01 | 2019-04-08 |
| Aclidinium Bromide Post-Authorisation Safety Study to Evaluate the Risk of Cardiovascular Endpoints Aclidinium bromide, Other COPD medication - Pulmonary Disease, Chronic Obstructive | Completed | AstraZeneca | 26839 | 2017-03-01 | 2023-01-31 | |
| Study to Assess Efficacy and Safety of Aclidinium Bromide and Aclidinium Bromide/Formoterol Fumarate in Stabile COPD Patients Aclidinium bromide/formoterol Fixed-Dose Combination, Aclidinium bromide, Formoterol Fumarate - COPD | Phase 3 | Completed | AstraZeneca | 1625 | 2017-02-02 | 2025-03-26 |
| Microbiome Use to Stratify Use of Inhaled Corticosteroids: MUSIC Trial Budesonide & formoterol fumarate and Aclidinium bromide, Fluticasone 500 & salmeterol and Aclidinium bromide, Fluticasone 250 & salmeterol and Aclidinium bromide - Chronic Obstructive Pulmonary Disease | Phase 4 | Completed | University of Dundee | 158 | 2016-12-01 | 2020-07-20 |
| AMPLIFY - D6571C00001 Duaklir USA Phase III Study Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg), Aclidinium bromide 400 μg (AB 400 μg), Formoterol fumarate 12 μg (FF 12 μg) - Chronic Obstructive Pulmonary Disease | Phase 3 | Completed | AstraZeneca | 1595 | 2016-07-05 | 2018-11-09 |
| Effect of Aclidinium/Formoterol on Nighttime Lung Function and Morning Symptoms in Chronic Obstructive Pulmonary Disease ACL/FOR, Placebo - COPD | Phase 4 | Completed | Queen's University | 40 | 2015-10-01 | 2019-07-12 |
| A Drug Utilisation Post-authorisation Study of New Users of Aclidinium Bromide (Monotherapy or in Combination) Aclidinium bromide, Aclidinium bromide/formoterol, Other COPD medication - Pulmonary Disease, Chronic Obstructive | Completed | AstraZeneca | 22155 | 2015-07-06 | 2018-02-22 | |
| Effect of Aclidinium/Formoterol on Lung Hyperinflation, Exercise Capacity and Physical Activity in Moderate to Severe COPD Patients Aclidinium/Formoterol, Placebo - Pulmonary Disease, Chronic Obstructive | Phase 4 | Completed | AstraZeneca | 267 | 2015-04-27 | 2018-10-09 |
| BENEFITS OF ACLIDINIUM BROMIDE IN THE RELIEF OF COPD SYMPTOMS INCLUDING COUGH Aclidinium Bromide, Placebo - Pulmonary Disease, Chronic Obstructive | Phase 4 | Completed | AstraZeneca | 300 | 2015-03-01 | 2017-04-21 |
| Acute Effect of Aclidinium on Hyperinflation and Ventilation Inhomogeneity in Severe COPD Patients Aclidinium Bromide, Glycopyrronium Bromide - Chronic Obstructive Pulmonary Disease | Phase 4 | Completed | University of Milan | 37 | 2014-06-01 | 2014-10-29 |
| A Double-blind, Placebo-controlled, Crossover Study to Assess the Effect of Aclidinium Bromide 400 μg Bid on COPD Symptoms and Sleep Quality After 3 Weeks of Treatment in Patients With Stable Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD) Aclidinium bromide, Placebo - Chronic Obstructive Pulmonary Disease (COPD) | Phase 4 | Completed | AstraZeneca | 30 | 2014-04-01 | 2016-11-09 |
| Evaluation of Long-Acting Muscarinic Antagonists in COPD Tiotropium, Aclidinium - Pulmonary Disease, Chronic Obstructive | Phase 4 | Completed | University of Dundee | 15 | 2014-02-01 | 2019-04-12 |
| 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 |
| Evaluate the Effect of Aclidinium Bromide on Long-term Cardiovascular Safety and Exacerbations in Moderate to Very Severe COPD Patients. Aclidinium Bromide, Placebo - COPD, Chronic Obstructive Pulmonary Disease | Phase 4 | Completed | AstraZeneca | 3635 | 2013-10-16 | 2018-12-06 |
| Study of Aclidinium Bromide/Formoterol Fumarate Compared With Salmeterol/Fluticasone Propionate in Patients With Chronic Obstructive Pulmonary Disease (COPD) Aclidinium Bromide / Formoterol Fumarate, Salmeterol / Fluticasone - Chronic Obstructive Pulmonary Disease (COPD) | Phase 3 | Completed | AstraZeneca | 933 | 2013-09-01 | 2016-03-07 |
| Efficacy and Safety of 400 μg Twice Daily of Aclidinium Bromide vs. Placebo When Administered to Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) aclidinium bromide 400 μg, aclidinium bromide placebo - COPD | Phase 3 | Completed | Daewoong Pharmaceutical Co. LTD. | 2012-08-01 | 2013-08-21 |
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Pulmonary Disease, Chronic Obstructive (39) · Emphysema (13) · Bronchitis, Chronic (9) · Bronchiolitis Obliterans Syndrome (4) · Bronchitis (4) · Motor Activity (1) · Sleep Initiation and Maintenance Disorders (1) · Smoking (1) · Smoking Cessation (1)
AstraZeneca (33) · University of Dundee (2) · Daewoong Pharmaceutical Co. LTD. (1) · Maastricht University Medical Center (1) · McGill University Health Centre/Research Institute of the McGill University Health Centre (1) · Queen's University (1) · Sunovion Respiratory Development Inc. (1) · University of Milan (1)
United States (14) · Canada (13) · Germany (13) · United Kingdom (11) · Czechia (8) · Hungary (8) · Spain (8) · Poland (7) · Italy (6) · Australia (4) · Bulgaria (4) · France (4) · Netherlands (4) · Russia (4) · South Africa (4)
Esther Garcia, MD (17) · Esther Garcia, Ph.D. (4) · Anna Ribera (1) · Anna Ribera, PhD (1) · Arvind Deva Manoharan, MBChB (1) · B M Smith, MD (1) · Brina Lipworth, MD (1) · Denis E O'Donnell, MD, FRCPC (1) · Esther Garcia, Ph. D. (1) · James Chalmers, MBChB, MRCP (1) · Jordi Castellsague, MD, MPH (1) · Kenneth R. Chapman, MD MSc FRCPC FACP FCCP (1) · Lowie Vanfleteren, MD, PhD (1) · Pierachille Santus, MD, PhD (1) · Robert Wise, MD (1)
PMID 28074135, PMID 21518460, PMID 26233481, PMID 27215749, PMID 28558833, PMID 31827323, PMID 42551404, PMID 21183326, PMID 21903737, PMID 22320148, PMID 22441743, PMID 22497752, PMID 23679347, PMID 24085591, PMID 25234803, PMID 25404569, PMID 25539654, PMID 25756831, PMID 26370136, PMID 26549785, PMID 26758884, PMID 27296819, PMID 27492833, PMID 28340861, PMID 28642315, PMID 29202767, PMID 30962681, PMID 31063575, PMID 32603714, PMID 33776428, PMID 34528220, PMID 34686204, PMID 35034195, PMID 35133636, PMID 35342289
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