Summary
Ciclesonide 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 Ciclesonide to Asthma: 8 have completed. The most advanced is Phase 4 (NCT06272370). The largest enrolment is 520 participants (NCT01455194). Registration activity spans 2001 to 2024. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 3 systematic reviews and 5 clinical trial publications. Publication years run from 2013 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 | 16 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 3 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT06272370 | Individualizing Treatment for Asthma in Primary Care 2024 | completed | Phase 4 | 103 |
| NCT03839433 | The Mannitol-Asthma-Ciclesonide-Study 2007 | completed | Phase 4 | 72 |
| 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 |
| NCT01455194 | Effect of High Dose Ciclesonide on Asthma Control 2011 | completed | Phase 3 | 520 |
| NCT00163397 | Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137) 2004 | completed | Phase 3 | 120 |
| NCT00174733 | Efficacy of Ciclesonide Versus Placebo Administered Either as Once Daily or Twice Daily in Patients Treated Previously With an Inhaled Corticosteroid 2005 | completed | Phase 3 | 456 |
| NCT00525772 | Effect of Ciclesonide on Exercise Induced Bronchoconstriction 2001 | completed | Phase 3 | 26 |
| NCT00163293 | Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101) 2005 | completed | Phase 3 | 240 |
Published literature
- Cochrane review Adverse events of inhaled corticosteroids in adult patients with asthma or chronic obstructive pulmonary disease: pairwise, network and dose-response meta-analysesPu X, Zhang Y, Peng L et al. · BMJ evidence-based medicine · 2026 · PMID 41241409
- 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 Inhaled ciclesonide does not affect production of antibodies or elimination of virus in patients with COVID-19: Subanalysis of a multicenter, open-label randomized trialSuzuki M, Matsunaga A, Miyoshi-Akiyama T et al. · Drug discoveries & therapeutics · 2023 · PMID 37899206
- Systematic review Quantitative comparison of different inhaled corticosteroids in the treatment of asthma in childrenZhu H, Liu H, Sui Z et al. · Pediatric research · 2023 · PMID 35545660
- Clinical trial publication A randomized clinical trial on inhaled ciclesonide for managing acute asthma in the emergency roomMartins DT, Carlos K, Carvalho LB et al. · Sao Paulo medical journal = Revista paulista de medicina · 2022 · PMID 35508008
- Meta-analysis Inhaled ciclesonide for outpatients with COVID-19: A meta-analysisHsu CK, Chao CM, Lai CC · Journal of microbiology, immunology, and infection = Wei mian yu gan ran za zhi · 2022 · PMID 35995666
- Meta-analysis Extrafine Versus Fine Inhaled Corticosteroids in Relation to Asthma Control: A Systematic Review and Meta-Analysis of Observational Real-Life StudiesSonnappa S, McQueen B, Postma DS et al. · The journal of allergy and clinical immunology. In practice · 2018 · PMID 28941668
- 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
- Clinical trial publication New insights into treatment of children with exercise-induced asthma symptomsStelmach I, Sztafiska A, Jerzyska J et al. · Allergy and asthma proceedings · 2016 · PMID 27931302
- Clinical trial publication Effect of once-daily generic ciclesonide on exhaled nitric oxide in atopic children with persistent asthmaMallol J, Aguirre V, Gallardo A et al. · Allergologia et immunopathologia · 2016 · PMID 26001339
- 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
- Clinical trial publication A randomised controlled trial of small particle inhaled steroids in refractory eosinophilic asthma (SPIRA)Hodgson D, Anderson J, Reynolds C et al. · Thorax · 2015 · PMID 25858909
- 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: dose-response effects on growthPruteanu AI, Chauhan BF, Zhang L et al. · The Cochrane database of systematic reviews · 2014 · PMID 25030199
- 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 Ciclesonide: long-term treatment of persistent asthma--no clear progressPrescrire international · 2013 · PMID 24171213
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 Ciclesonide approved for Asthma?
Ciclesonide 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 Ciclesonide in clinical trials for Asthma?
ClinicalTrials.gov lists 8 registered trials linking Ciclesonide to Asthma: 8 have completed. The most advanced is Phase 4 (NCT06272370). The largest enrolment is 520 participants (NCT01455194). Registration activity spans 2001 to 2024.
What does the evidence show for Ciclesonide in Asthma?
Ciclesonide 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.