Summary
Beclomethasone Dipropionate 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 Beclomethasone Dipropionate to Asthma: 8 have completed. The most advanced is Phase 4 (NCT01520688). The largest enrolment is 815377 participants (NCT01141439). Registration activity spans 2001 to 2022. The literature layer holds 13 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2007 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 | 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 | 13 (5 Cochrane reviews, 5 clinical trial publications, 2 systematic reviews, 1 meta-analysis) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01520688 | Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth 2012 | completed | Phase 4 | 32 |
| NCT04886999 | Study in Adult Patients With Moderate to Severe Asthma 2022 | completed | Phase 3 | 78 |
| NCT01345916 | Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients 2011 | completed | Phase 3 | 932 |
| NCT00200967 | Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE) 2004 | completed | Phase 3 | 87 |
| NCT00094016 | Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children 2004 | completed | Phase 3 | 440 |
| NCT00497237 | Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate Plus Formoterol vs Fluticasone Propionate Plus Salmeterol in the 6 Months Step Down Treatment of Asthma 2007 | completed | Phase 3 | 382 |
| NCT01141439 | Real-world Effectiveness and Cost-effectiveness of Leading Inhaled Corticosteroids in Asthma Management 2001 | completed | Not applicable | 815,377 |
| NCT01287351 | Real-world Effectiveness and Cost-effectiveness of Qvar Versus FP, a US Study 2004 | completed | Not applicable | 82,903 |
Published literature
- 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 [Efficacy and safety of inhaled salbutamol sulfate combined with beclomethasone dipropionate in children with bronchial asthma: a randomized controlled study]Chen CZ, Yang Q · Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2025 · PMID 41250537
- Clinical trial publication Evaluating the impact of changing inhaler color on perception of symptoms and disease burden in patients with asthma: the FEEL studyBlasi F, D'Amato M, Patella V et al. · The Journal of asthma : official journal of the Association for the Care of Asthma · 2025 · PMID 39772981
- Clinical trial publication Comparison of extrafine beclomethasone dipropionate/formoterol fumarate dry powder inhaler and pressurized metered-dose inhaler in Chinese patients with asthma: the FORTUNE studyZheng J, Zhang J, Fu X et al. · The Journal of asthma : official journal of the Association for the Care of Asthma · 2024 · PMID 37878325
- Clinical trial publication As-Needed Use of Short-Acting β(2)-Agonists Alone Versus As-Needed Use of Short-Acting β(2)-Agonists Plus Inhaled Corticosteroids in Pediatric Patients With Mild Intermittent (Step 1) Asthma: A Cost-Effectiveness AnalysisRodríguez-Martínez CE, Sossa-Briceño MP, Buendia JA · The journal of allergy and clinical immunology. In practice · 2022 · PMID 35259534
- Systematic review Efficacy and safety of inhaled corticosteroids relative to fluticasone propionate: a systematic review of randomized controlled trials in asthmaYeo SH, Aggarwal B, Shantakumar S et al. · Expert review of respiratory medicine · 2017 · PMID 28752776
- Meta-analysis Adrenal suppression by inhaled corticosteroids in patients with asthma: A systematic review and quantitative analysisKowalski ML, Wojciechowski P, Dziewonska M et al. · Allergy and asthma proceedings · 2016 · PMID 26831841
- Systematic review Principal findings of systematic reviews for chronic treatment in childhood asthmaCastro-Rodriguez JA, Rodrigo GJ, Rodriguez-Martinez CE · The Journal of asthma : official journal of the Association for the Care of Asthma · 2015 · PMID 25275887
- 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 Omalizumab for asthma in adults and childrenNormansell R, Walker S, Milan SJ et al. · The Cochrane database of systematic reviews · 2014 · PMID 24414989
- Cochrane review Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and childrenQuon BS, Fitzgerald JM, Lemière C et al. · The Cochrane database of systematic reviews · 2010 · PMID 21154378
- Cochrane review Increased versus stable doses of inhaled corticosteroids for exacerbations of chronic asthma in adults and childrenQuon BS, Fitzgerald JM, Lemière C et al. · The Cochrane database of systematic reviews · 2010 · PMID 20927759
- Cochrane review Fluticasone versus beclomethasone or budesonide for chronic asthma in adults and childrenAdams N, Lasserson TJ, Cates CJ et al. · The Cochrane database of systematic reviews · 2007 · PMID 17943772
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 Beclomethasone Dipropionate approved for Asthma?
Beclomethasone Dipropionate 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 Beclomethasone Dipropionate in clinical trials for Asthma?
ClinicalTrials.gov lists 8 registered trials linking Beclomethasone Dipropionate to Asthma: 8 have completed. The most advanced is Phase 4 (NCT01520688). The largest enrolment is 815377 participants (NCT01141439). Registration activity spans 2001 to 2022.
What does the evidence show for Beclomethasone Dipropionate in Asthma?
Beclomethasone Dipropionate 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.