Summary
Flunisolide 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 3 registered trials linking Flunisolide to Asthma: 3 have completed. The most advanced is Phase 1 (NCT00203684). The largest enrolment is 17448 participants (NCT01347060). Registration activity spans 2009 to 2015. The literature layer holds 16 publications for this pair: 4 Cochrane reviews, 3 meta-analyses, 1 systematic review, 3 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2001 to 2016. 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 | 58.0 (trials 8.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 3 total: 0 recruiting, 0 active / not yet recruiting, 3 completed, 0 other |
| Linked publications | 16 (5 clinical trial publications, 4 Cochrane reviews, 3 meta-analyses, 3 randomised controlled trial publications, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00203684 | Mentored Patient-Oriented Research Career Development Award | completed | Phase 1 | 57 |
| NCT02404103 | Flunisolide HFA in Children With Small Airway Disease 2015 | completed | Not applicable | 26 |
| NCT01347060 | Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy 2009 | completed | Not applicable | 17,448 |
Published literature
- 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
- Cochrane review Effectiveness of inhaled corticosteroids in the treatment of acute asthma in children in the emergency department: a meta-analysisSu XM, Yu N, Kong LF et al. · Annals of medicine · 2014 · PMID 24328420
- Systematic review Inhaled versus systemic corticosteroids for acute asthma in children. A systematic reviewBeckhaus AA, Riutort MC, Castro-Rodriguez JA · Pediatric pulmonology · 2014 · PMID 23929666
- Clinical trial publication Linear growth and bone maturation are unaffected by 1 year of therapy with inhaled flunisolide hydrofluoroalkane in prepubescent children with mild persistent asthma: a randomized, double-blind, placebo-controlled trialBensch GW, Greos LS, Gawchik S et al. · Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2011 · PMID 21962092
- Clinical trial publication High-dose inhaled flunisolide versus budesonide in the treatment of acute asthma exacerbations in preschool-age childrenDecimo F, Maiello N, Miraglia Del Giudice M et al. · International journal of immunopathology and pharmacology · 2009 · PMID 19505390
- Meta-analysis Relative oral corticosteroid-sparing effect of 7 inhaled corticosteroids in chronic asthma: a meta-analysisAbdullah AK, Khan S · Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2008 · PMID 18681088
- Clinical trial publication Flunisolide decreases exhaled nitric oxide and nitrotyrosine levels in asthmatic childrenBodini A, Peroni DG, Zardini F et al. · Mediators of inflammation · 2006 · PMID 17047290
- Clinical trial publication Effects of long-term inhaled corticosteroids on adrenal function in patients with asthmaWhite M, Crisalida T, Li H et al. · Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2006 · PMID 16597078
- Meta-analysis Meta-analysis finds use of inhaled corticosteroids during pregnancy safe: a systematic meta-analysis reviewRahimi R, Nikfar S, Abdollahi M · Human & experimental toxicology · 2006 · PMID 16937916
- Clinical trial publication Evidence of remodeling in peripheral airways of patients with mild to moderate asthma: effect of hydrofluoroalkane-flunisolideBergeron C, Hauber HP, Gotfried M et al. · The Journal of allergy and clinical immunology · 2005 · PMID 16275364
- Randomized controlled trial Effects of drug treatment on inflammation and hyperreactivity of airways and on immune variables in cats with experimentally induced asthmaReinero CR, Decile KC, Byerly JR et al. · American journal of veterinary research · 2005 · PMID 16111148
- Randomized controlled trial Comparison of patient preference and ease of teaching inhaler technique for Pulmicort Turbuhaler versus pressurized metered-dose inhalersWelch MJ, Nelson HS, Shapiro G et al. · Journal of aerosol medicine : the official journal of the International Society for Aerosols in Medicine · 2004 · PMID 15294063
- Randomized controlled trial A randomized controlled trial of inhaled flunisolide in the management of acute asthma in childrenNakanishi AK, Klasner AK, Rubin BK · Chest · 2003 · PMID 12969999
- Meta-analysis Improved asthma control after changing from low-to-medium doses of other inhaled corticosteroids to low-dose fluticasone propionateStoloff SW, Srebro SH, Edwards LD et al. · MedGenMed : Medscape general medicine · 2001 · PMID 11549975
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 Flunisolide approved for Asthma?
Flunisolide 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 Flunisolide in clinical trials for Asthma?
ClinicalTrials.gov lists 3 registered trials linking Flunisolide to Asthma: 3 have completed. The most advanced is Phase 1 (NCT00203684). The largest enrolment is 17448 participants (NCT01347060). Registration activity spans 2009 to 2015.
What does the evidence show for Flunisolide in Asthma?
Flunisolide 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.