Summary
Glycopyrronium Bromide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in COPD would be drug repurposing rather than first-in-human development. This does not mean it is approved for COPD. ClinicalTrials.gov lists 8 registered trials linking Glycopyrronium Bromide to COPD: 8 have completed. The most advanced is Phase 4 (NCT04606901). The largest enrolment is 3433 participants (NCT04320342). Registration activity spans 2009 to 2022. The literature layer holds 12 publications for this pair: 1 Cochrane review, 4 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2012 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Chronic Obstructive Pulmonary Disease ranks 505 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Effectively zero — airflow obstruction is irreversible by definition in COPD; FEV1 decline continues at 30-60 mL/year on standard care.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 80.0 (trials 30.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 8 completed, 0 other |
| Linked publications | 12 (5 clinical trial publications, 4 meta-analyses, 2 systematic reviews, 1 Cochrane review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT02233543 | A Multicenter, 4-week Crossover (Total Duration 12 Weeks) to Determine the Impact of QVA149 on Nocturnal Oxygen Levels in Chronic Obstructive Pulmonary Disease (COPD) 2014 | completed | Phase 4 | 38 |
| NCT04606901 | Comparison of Time to Extubation Using Sugammadex or Neostigmine 2021 | completed | Phase 4 | 58 |
| NCT02347072 | 24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003, Open-Label Spiriva® Respimat® as an Active Control, and Placebo 2015 | completed | Phase 3 | 80 |
| NCT01005901 | A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo 2009 | completed | Phase 3 | 1,324 |
| NCT01154127 | Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD) 2010 | completed | Phase 3 | 108 |
| NCT04320342 | A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD 2022 | completed | Phase 3 | 3,433 |
| NCT03084796 | A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease 2017 | completed | Phase 2 | 733 |
| NCT02196714 | PK Study of PT003 and PT001 in Japanese Healthy Subjects 2014 | completed | Phase 1 | 24 |
Published literature
- Cochrane review Efficacy of single-inhaler triple therapies for chronic obstructive pulmonary disease: a systematic review and network meta-analysisZhang Y, Zhao P, Zhang Y · BMC pulmonary medicine · 2026 · PMID 41998645
- Meta-analysis Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Triple Therapy Compared with Other Therapies for the Treatment of COPD: A Network Meta-AnalysisIsmaila AS, Haeussler K, Czira A et al. · Advances in therapy · 2022 · PMID 35849317
- Clinical trial publication Ethnic Sensitivity Study of the Extrafine, Single-Inhaler, Triple Therapy Beclomethasone Dipropionate, Formoterol Fumarate, and Glycopyrronium Bromide Pressurized Metered Dose Inhaler in Japanese and Caucasian Healthy Individuals: A Randomized, Double-Blind, Single-Dose Crossover StudyCella M, Täubel J, Delestre-Levai I et al. · Clinical therapeutics · 2021 · PMID 34600734
- Clinical trial publication Efficacy and Safety of Inhaled Glycopyrronium Bromide in COPD: A Randomized, Parallel Group, Dose-Ranging Study (GLIMMER)Kerwin E, Feldman G, Pearle J et al. · COPD · 2021 · PMID 33709856
- Meta-analysis Efficacy and Safety of Budesonide/Glycopyrronium/Formoterol Fumarate versus Other Triple Combinations in COPD: A Systematic Literature Review and Network Meta-analysisBourdin A, Molinari N, Ferguson GT et al. · Advances in therapy · 2021 · PMID 33929661
- Clinical trial publication Evaluation of systemic absorption and bronchodilator effect of glycopyrronium bromide delivered by nebulizer or a dry powder inhaler in subjects with chronic obstructive pulmonary diseaseLeaker BR, Singh D, Nicholson GC et al. · Respiratory research · 2019 · PMID 31253162
- Clinical trial publication Dose-response of an extrafine dry powder inhaler formulation of glycopyrronium bromide: randomized, double-blind, placebo-controlled, dose-ranging study (GlycoNEXT)Beeh KM, Emirova A, Prunier H et al. · International journal of chronic obstructive pulmonary disease · 2018 · PMID 29872288
- Clinical trial publication Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over StudiesKerwin E, Ferguson GT, Sanjar S et al. · Lung · 2017 · PMID 28993871
- Meta-analysis Role of combined indacaterol and glycopyrronium bromide (QVA149) for the treatment of COPD in JapanHorita N, Kaneko T · International journal of chronic obstructive pulmonary disease · 2015 · PMID 25960646
- Systematic review Clinical benefit of fixed-dose dual bronchodilation with glycopyrronium and indacaterol once daily in patients with chronic obstructive pulmonary disease: a systematic reviewUlrik CS · International journal of chronic obstructive pulmonary disease · 2014 · PMID 24729699
- Meta-analysis Comparative efficacy of long-acting bronchodilators for COPD: a network meta-analysisCope S, Donohue JF, Jansen JP et al. · Respiratory research · 2013 · PMID 24093477
- Systematic review Once-daily glycopyrronium bromide, a long-acting muscarinic antagonist, for chronic obstructive pulmonary disease: a systematic review of clinical benefitUlrik CS · International journal of chronic obstructive pulmonary disease · 2012 · PMID 23055716
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Glycopyrronium Bromide approved for COPD?
Glycopyrronium Bromide has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in COPD would be drug repurposing rather than first-in-human development. This does not mean it is approved for COPD. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Glycopyrronium Bromide in clinical trials for COPD?
ClinicalTrials.gov lists 8 registered trials linking Glycopyrronium Bromide to COPD: 8 have completed. The most advanced is Phase 4 (NCT04606901). The largest enrolment is 3433 participants (NCT04320342). Registration activity spans 2009 to 2022.
What does the evidence show for Glycopyrronium Bromide in COPD?
Glycopyrronium Bromide has both completed registered trials and synthesis-level publications linked to COPD. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.