Summary
Fluticasone Propionate 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 Fluticasone Propionate to Asthma: 8 have completed. The most advanced is Phase 4 (NCT02388373). The largest enrolment is 815377 participants (NCT01141439). Registration activity spans 2001 to 2014. The literature layer holds 17 publications for this pair: 5 Cochrane reviews, 5 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2014 to 2025. 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 | 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 | 17 (5 Cochrane reviews, 5 meta-analyses, 5 clinical trial publications, 2 systematic reviews) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
| NCT01520688 | Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth 2012 | completed | Phase 4 | 32 |
| NCT01165138 | Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics 2010 | completed | Phase 3 | 612 |
| NCT00163371 | Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208) 2005 | completed | Phase 3 | 28 |
| NCT00400855 | Study on the Effects of an AMP Challenge on Asthmatic Patients Following Treatment With Fluticasone Propionate 2005 | completed | Phase 2 | 49 |
| NCT01516073 | 12-Week Study in Adult Subjects With Asthma 2012 | completed | Phase 2 | 629 |
| NCT01669070 | A Four-way Crossover, Single and Repeat Dose Study to Determine the Dose Proportionality and Absolute Bioavailability of Fluticasone Furoate Inhalation Powder Administered by Novel Dry Powder Inhaler (NDPI) 2012 | completed | Phase 1 | 36 |
| NCT01141439 | Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management 2001 | completed | Not applicable | 815,377 |
Published literature
- Systematic review Local and systemic adverse effects of inhaled corticosteroids - Does ciclesonide differ from other inhaled corticosteroids?Ottesen TG, Rovsing AH, Ulrik CS · Respiratory medicine · 2025 · PMID 39921068
- Clinical trial publication Correlation Analysis of Serum 25-Hydroxyvitamin D Levels With Immune Function and Calcium-Phosphate Metabolism in Patients With Bronchial Asthma Treated With Combination TherapyWu D, Wang J, Wei Y et al. · Physiological research · 2024 · PMID 39560193
- Clinical trial publication Once-daily fluticasone furoate/vilanterol vs once-daily fluticasone furoate in patients with asthma aged 5 to 17 yearsBareille P, Forth R, Imber V et al. · Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2024 · PMID 38936466
- 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
- Clinical trial publication Effectiveness of a Maintenance and Reliever Digihaler System in Asthma: 24-Week Randomized Study (CONNECT2)Mosnaim GS, Hoyte FCL, Safioti G et al. · The journal of allergy and clinical immunology. In practice · 2024 · PMID 38040117
- Meta-analysis Clinical efficacy of montelukast sodium combination therapy for cough variant asthma in children: A meta-analysisYang S, He X, Zhang R · Pediatric pulmonology · 2024 · PMID 38501316
- Meta-analysis Efficacy and safety of fluticasone propionate/salmeterol and fluticasone propionate monotherapy in step-up treatment of childhood asthma: A systematic review and meta-analysisLi H, Dong T, Luan J · Heart & lung : the journal of critical care · 2024 · PMID 37740997
- Systematic review Exploring the Relationship between Inhaled Corticosteroid Usage, Asthma Severity, and Sleep-Disordered Breathing: A Systematic Literature ReviewZaffanello M, Ferrante G, Piazza M et al. · Advances in respiratory medicine · 2024 · PMID 39194421
- Clinical trial publication Comparing Budesonide and Fluticasone Propionate in Children with Moderate to Severe Asthma: A Pilot Randomized Controlled TrialSadeghzadeh M, Khoshnevisasl P, Ahmadiafshar A et al. · Iranian journal of allergy, asthma, and immunology · 2023 · PMID 38477950
- Meta-analysis An efficacy and safety evaluation of montelukast + fluticasone propionate vs. fluticasone propionate in the treatment of cough variant asthma in children: a meta-analysisWei Z, Li S · BMC pulmonary medicine · 2023 · PMID 38053076
- 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 Impact of inhaled fluticasone propionate/salmeterol on health-related quality of life in asthma: A network meta-analysisManeechotesuwan K, Singh D, Fritscher LG et al. · Respiratory medicine · 2022 · PMID 36257125
- Meta-analysis Quantitative comparison of dose-effect and time-course of fluticasone furoate and fluticasone propionate in adult and adolescent patients with persistent asthma: A systematic review and meta-analysisZhong Y, Li L, Chen R et al. · Respirology (Carlton, Vic.) · 2022 · PMID 35043513
- Cochrane review The efficacy and safety of fluticasone propionate/formoterol compared with fluticasone propionate/salmeterol in treating pediatric asthma: a systematic review and meta-analysisGuan R, Liu Y, Ren D et al. · The Journal of international medical research · 2020 · PMID 31852314
- 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
- Cochrane review Stopping long-acting beta2-agonists (LABA) for children with asthma well controlled on LABA and inhaled corticosteroidsKew KM, Beggs S, Ahmad S · The Cochrane database of systematic reviews · 2015 · PMID 25997166
- Cochrane review Inhaled corticosteroids in children with persistent asthma: effects on growthZhang L, Prietsch SO, Ducharme FM · The Cochrane database of systematic reviews · 2014 · PMID 25030198
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 Fluticasone Propionate approved for Asthma?
Fluticasone Propionate 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 Fluticasone Propionate in clinical trials for Asthma?
ClinicalTrials.gov lists 8 registered trials linking Fluticasone Propionate to Asthma: 8 have completed. The most advanced is Phase 4 (NCT02388373). The largest enrolment is 815377 participants (NCT01141439). Registration activity spans 2001 to 2014.
What does the evidence show for Fluticasone Propionate in Asthma?
Fluticasone Propionate 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.