Summary
Umeclidinium 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 ClinicalTrials.gov lists 8 registered trials linking Umeclidinium Bromide to COPD: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03474081). The largest enrolment is 11316 participants (NCT05127304). Registration activity spans 2007 to 2021. The literature layer holds 7 publications for this pair: 1 Cochrane review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2014 to 2021. 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 | 68.0 (trials 30.0, literature 18.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 7 (5 clinical trial publications, 1 Cochrane review, 1 randomised controlled trial publication) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT03474081 | A Comparative Study Between Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) Single Inhaler Triple Therapy Versus Tiotropium Monotherapy in Subjects With Chronic Obstructive Pulmonary Disease (COPD) 2018 | completed | Phase 4 | 800 |
| NCT03949842 | Legend: TRELEGY Real World Chronic Obstructive Pulmonary Disease (COPD) Effectiveness Study 2019 | withdrawn | Phase 4 | — |
| NCT01313637 | A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD 2011 | completed | Phase 3 | 1,493 |
| NCT01822899 | A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD) 2013 | completed | Phase 3 | 717 |
| NCT02487446 | Efficacy and Safety Study of QVA149 in COPD Patients 2015 | completed | Phase 3 | 357 |
| NCT01372410 | A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD) 2011 | completed | Phase 2 | 163 |
| NCT00515502 | Safety Study Using GSK573719 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease 2007 | completed | Phase 2 | 24 |
| NCT05127304 | A Study Using US Medical and Pharmacy Claim Records to Compare the Resource Use, Cost, and Outcomes of People With COPD Who Take Either Tiotropium + Olodaterol or Fluticasone + Umeclidinium + Vilanterol 2021 | completed | Not applicable | 11,316 |
Published literature
- Clinical trial publication Population Pharmacokinetic Modeling of Fluticasone Furoate, Umeclidinium Bromide, and Vilanterol in Patients with Asthma, Using Data from a Phase IIIA Study (CAPTAIN)Yang S, Lee LA, Sule N et al. · Clinical pharmacokinetics · 2021 · PMID 33598874
- Clinical trial publication Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary DiseaseMehta R, Farrell C, Hayes S et al. · Clinical pharmacokinetics · 2020 · PMID 31321713
- Clinical trial publication Cost-effectiveness analysis of umeclidinium bromide/vilanterol 62.5/25 mcg versus tiotropium/olodaterol 5/5 mcg in symptomatic patients with chronic obstructive pulmonary disease: a Spanish National Healthcare System perspectiveDriessen MT, Whalen J, Seewoodharry Buguth B et al. · Respiratory research · 2018 · PMID 30458866
- 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
- Cochrane review Umeclidinium bromide versus placebo for people with chronic obstructive pulmonary disease (COPD)Ni H, Htet A, Moe S · The Cochrane database of systematic reviews · 2017 · PMID 28631387
- Clinical trial publication Long-term (52 weeks) safety and tolerability of umeclidinium in Japanese patients with chronic obstructive pulmonary diseaseYamagata E, Soutome T, Hashimoto K et al. · Current medical research and opinion · 2016 · PMID 26782971
- Randomized controlled trial Efficacy and safety of umeclidinium/vilanterol 62.5/25 mcg and tiotropium 18 mcg in chronic obstructive pulmonary disease: results of a 24-week, randomized, controlled trialMaleki-Yazdi MR, Kaelin T, Richard N et al. · Respiratory medicine · 2014 · PMID 25458157
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 Umeclidinium Bromide approved for COPD?
Umeclidinium 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 Umeclidinium Bromide in clinical trials for COPD?
ClinicalTrials.gov lists 8 registered trials linking Umeclidinium Bromide to COPD: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT03474081). The largest enrolment is 11316 participants (NCT05127304). Registration activity spans 2007 to 2021.
What does the evidence show for Umeclidinium Bromide in COPD?
Umeclidinium 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.