Summary
Formoterol Fumarate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Asthma would be drug repurposing rather than first-in-human development. This does not mean it is approved for Asthma. ClinicalTrials.gov lists 8 registered trials linking Formoterol Fumarate to Asthma: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02388373). The largest enrolment is 12460 participants (NCT01444430). Registration activity spans 2003 to 2022. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2003 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 Asthma ranks 642 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: 26% of childhood-onset asthma in clinical remission by adulthood; <20% adult-onset achieves sustained remission; 65% long-term remission in mild-moderate vs 16% in severe.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 78.0 (trials 28.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 1 systematic 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02388373 | A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down 2014 | completed | Phase 4 | 225 |
| NCT04886999 | Study in Adult Patients With Moderate to Severe Asthma 2022 | completed | Phase 3 | 78 |
| NCT04609904 | Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (LOGOS) 2021 | completed | Phase 3 | 2,187 |
| NCT00235911 | Symbicort Single Inhaler Therapy for Asthma in a General Practice Setting 2003 | completed | Phase 3 | 100 |
| NCT01444430 | A 6 Month Safety Study Comparing Symbicort With Inhaled Corticosteroid Only in Asthmatic Adults and Adolescents 2011 | completed | Phase 3 | 12,460 |
| NCT00746330 | Single Dose Study of the Effect of Formoterol Fumarate in Combination With Mometasone Furoate Inhaled Via a Pressurized Metered Dose Inhaler (pMDI) in Children Aged 5-11 Years Old With Persistent Asthma 2008 | completed | Phase 2 | 32 |
| NCT01711086 | Safety and Efficacy of the Inspiromatic Inhaler in Comparison to the Aerolizer Inhaler When Delivering Formoterol 2012 | status unknown | PHASE1, PHASE2 | 30 |
| NCT03319043 | Observation of Cough Variant Asthma Treated in Combination of Chanqin Granules. 2017 | status unknown | PHASE1, PHASE2 | 120 |
Published literature
- Clinical trial publication Safety and tolerability of the low global warming potential propellant HFA-152a in patients with asthma receiving beclometasone dipropionate/formoterol fumarate/glycopyrronium: The TRECOS studySingh D, Mancini L, Melis G et al. · Respiratory medicine · 2026 · PMID 41951188
- Clinical trial publication Budesonide-glycopyrronium-formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trialsPapi A, Wise RA, Jackson DJ et al. · The Lancet. Respiratory medicine · 2026 · PMID 41692019
- Clinical trial publication Improved lung function with beclomethasone/formoterol versus beclomethasone alone in asthma: the FORCE2 studyWeinstein S, Legramandi L, Mathews KS et al. · The Journal of asthma : official journal of the Association for the Care of Asthma · 2026 · PMID 41231513
- 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 Efficacy and safety of Once-Daily Vilanterol/Fluticasone furoate MDI in persistent asthma: Phase 3 OD-INHALE StudyKumar A, Jain MK, Barge VB et al. · The Journal of asthma : official journal of the Association for the Care of Asthma · 2024 · PMID 38488853
- 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
- Cochrane review Long-Term Fluticasone Propionate/Formoterol Fumarate Combination Therapy Is Associated with a Low Incidence of Severe Asthma ExacerbationsPapi A, Mansur AH, Pertseva T et al. · Journal of aerosol medicine and pulmonary drug delivery · 2016 · PMID 27104231
- Meta-analysis Appraisal of lens opacity with mometasone furoate/formoterol fumarate combination in patients with COPD or asthmaMaspero J, Cherrez I, Doherty DE et al. · Respiratory medicine · 2014 · PMID 25044280
- Cochrane review Formoterol for acute asthma in the emergency department: a systematic review with meta-analysisRodrigo GJ, Neffen H, Colodenco FD et al. · Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2010 · PMID 20377114
- Systematic review Inhaled corticosteroids or long-acting beta-agonists alone or in fixed-dose combinations in asthma treatment: a systematic review of fluticasone/budesonide and formoterol/salmeterolFrois C, Wu EQ, Ray S et al. · Clinical therapeutics · 2009 · PMID 20110019
- Meta-analysis Systematic review and economic analysis of the comparative effectiveness of different inhaled corticosteroids and their usage with long-acting beta2 agonists for the treatment of chronic asthma in children under the age of 12 yearsMain C, Shepherd J, Anderson R et al. · Health technology assessment (Winchester, England) · 2008 · PMID 18485272
- Meta-analysis Systematic review and economic analysis of the comparative effectiveness of different inhaled corticosteroids and their usage with long-acting beta2 agonists for the treatment of chronic asthma in adults and children aged 12 years and overShepherd J, Rogers G, Anderson R et al. · Health technology assessment (Winchester, England) · 2008 · PMID 18485271
- Cochrane review Long-acting beta2-agonists for chronic asthma in adults and children where background therapy contains varied or no inhaled corticosteroidWalters EH, Gibson PG, Lasserson TJ et al. · The Cochrane database of systematic reviews · 2007 · PMID 17253458
- Cochrane review Inhaled long acting beta agonists for stable chronic asthmaWalters EH, Walters JA, Gibson MD · The Cochrane database of systematic reviews · 2003 · PMID 14583933
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 Asthma?
Formoterol Fumarate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Asthma would be drug repurposing rather than first-in-human development. This does not mean it is approved for Asthma. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Formoterol Fumarate in clinical trials for Asthma?
ClinicalTrials.gov lists 8 registered trials linking Formoterol Fumarate to Asthma: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02388373). The largest enrolment is 12460 participants (NCT01444430). Registration activity spans 2003 to 2022.
What does the evidence show for Formoterol Fumarate in Asthma?
Formoterol Fumarate has both completed registered trials and synthesis-level publications linked to Asthma. 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.