Summary
Formoterol Fumarate 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 Formoterol Fumarate to COPD: 8 have completed. The most advanced is Phase 4 (NCT00379028). The largest enrolment is 3433 participants (NCT04320342). Registration activity spans 2006 to 2024. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2020 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 | 14 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00379028 | Airway Clearance Study 2006 | completed | Phase 4 | 54 |
| NCT01656005 | Beta Blocker Therapy in Moderate to Severe COPD 2012 | completed | Phase 4 | 18 |
| NCT00929851 | BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate) 2009 | completed | Phase 3 | 1,199 |
| 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 |
| NCT02497001 | A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos) 2015 | completed | Phase 3 | 1,902 |
| 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 |
| NCT01555099 | Multi-centre Study to Assess the Efficacy and Safety of AZD5423 in COPD Patients on a Background Therapy of Formoterol 2012 | completed | Phase 2 | 353 |
| NCT07103642 | EXACERBATIONS AND REAL-WORLD OUTOMES AMONG PATIENTS WITH COPD INITIATING BREZTRI (EROS+CP Japan Study) 2024 | completed | Not applicable | 3,402 |
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
- Cochrane review Safety and efficacy of budesonide/glycopyrrolate/formoterol fumarate compared with glycopyrrolate/formoterol fumarate for the treatment of COPD: A systematic review and meta-analysisThathera P, Garg A, Ahmed S et al. · Journal of the American Pharmacists Association : JAPhA · 2026 · PMID 40840693
- Clinical trial publication Effectiveness and Safety of Glycopyrronium-Formoterol-Budesonide Triple Therapy in Chronic Obstructive Pulmonary Disease (AIR-FORCE): An Open-Label Multi-Centric Phase 4 StudyNath AR, Kumar A, Bhate AS et al. · Advances in respiratory medicine · 2025 · PMID 41439854
- Clinical trial publication Frequent productive cough in COPD relates to exacerbation risk and treatment benefit from budesonide/glycopyrrolate/formoterol fumarate: a post hoc analysis of KRONOSPatel M, Marshall J, Martinez FJ et al. · Respiratory medicine · 2025 · PMID 41237914
- Clinical trial publication Step up to triple therapy versus switch to dual bronchodilator therapy in patients with COPD on an inhaled corticosteroid/long-acting β(2)-agonist: post-hoc analyses of KRONOSSingh D, Bafadhel M, Arya N et al. · Respiratory research · 2025 · PMID 40340809
- Meta-analysis Real-World Effectiveness of Triple Extrafine Fixed-Dose Combination with Beclomethasone/Formoterol/Glycopyrronium on Symptoms and Lung Function in COPD: A Systematic Review and Meta-AnalysisRogliani P, Manzetti GM, Cazzola M et al. · International journal of chronic obstructive pulmonary disease · 2025 · PMID 40453981
- Clinical trial publication Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate versus Dual Therapies for Patients with COPD and Phenotypic Features of Asthma: A Pooled Post Hoc Analysis of KRONOS and ETHOSMuro S, Seki M, Hurst JR et al. · International journal of chronic obstructive pulmonary disease · 2024 · PMID 39691156
- Clinical trial publication Beclometasone Dipropionate/Formoterol Fumarate is Similarly Effective to Budesonide/Formoterol Fumarate in Chinese Patients with COPD: The FORSYYN Double-Blind, Randomised StudyWen F, Wu Y, Xing C et al. · COPD · 2024 · PMID 39529298
- Randomized controlled trial Effects of inhaled beclometasone dipropionate/formoterol fumarate/glycopyrronium vs. beclometasone dipropionate/formoterol fumarate and placebo on lung hyperinflation and exercise endurance in chronic obstructive pulmonary disease: a randomised controlled trialWatz H, Kirsten AM, Ludwig-Sengpiel A et al. · Respiratory research · 2024 · PMID 39420338
- Meta-analysis Mortality risk reduction with budesonide/glycopyrrolate/formoterol fumarate versus fluticasone furoate/umeclidinium/vilanterol in COPD: a matching-adjusted indirect comparison based on ETHOS and IMPACTStolz D, Hermansson E, Ouwens M et al. · Current medical research and opinion · 2023 · PMID 37583267
- Cochrane review The Efficacy and Safety of Budesonide/Glycopyrronium/Formoterol in the Treatment of COPD in the ElderlyGuo M, Yu C, Li Z · Contrast media & molecular imaging · 2022 · PMID 36072633
- Cochrane review A review of the efficacy and safety of fluticasone propionate/formoterol fixed-dose combinationKilaru SC, Bansal AG, Naik VS et al. · Expert review of respiratory medicine · 2022 · PMID 35727177
- 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
- Cochrane review A comparison of the efficacy and safety of combined aclidinium bromide and formoterol fumarate in the treatment of chronic obstructive pulmonary disease: A protocol for systematic review and meta-analysisLu H, Huang YT, Chen HJ et al. · Medicine · 2020 · PMID 33217787
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 Formoterol Fumarate approved for COPD?
Formoterol Fumarate 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 Formoterol Fumarate in clinical trials for COPD?
ClinicalTrials.gov lists 8 registered trials linking Formoterol Fumarate to COPD: 8 have completed. The most advanced is Phase 4 (NCT00379028). The largest enrolment is 3433 participants (NCT04320342). Registration activity spans 2006 to 2024.
What does the evidence show for Formoterol Fumarate in COPD?
Formoterol Fumarate 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.