Summary
Budesonide 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 ClinicalTrials.gov lists 8 registered trials linking Budesonide to Asthma: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00641446). The largest enrolment is 12460 participants (NCT01444430). Registration activity spans 2001 to 2022. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2022 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 | 77.0 (trials 27.0, 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 | 15 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01520688 | Effect of Flovent Discus vs QVAR vs Pulmicort Flexhaler on Short Term Growth 2012 | completed | Phase 4 | 32 |
| NCT00641446 | Varicella Vaccination With Pulmicort 2001 | completed | Phase 4 | 250 |
| 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 |
| NCT03788057 | Inflammatory Indices in Predicting the Failure of Inhaled Corticosteroids Reduction in Young Participants With Asthma 2016 | completed | Not applicable | 58 |
| NCT06080945 | Tailored Pharmacist-led Intervention to Improve Adherence to Budesonide 2022 | status unknown | Not applicable | 102 |
| NCT03319043 | Observation of Cough Variant Asthma Treated in Combination of Chanqin Granules. 2017 | status unknown | PHASE1, PHASE2 | 120 |
Published literature
- 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 Analysis of risk factors for recurrence in children with asthmatic bronchopneumonia during remission and discussion on the therapeutic effect of diprophylline combined with budesonideHou G · Pakistan journal of pharmaceutical sciences · 2026 · PMID 41546592
- Clinical trial publication Budesonide-formoterol versus terbutaline reliever in adults with asthma using maintenance inhaled corticosteroids in New Zealand (INFORM ASTHMA): an open-label, parallel-group, randomised, controlled, phase 4 trialNoble JH, Bean O, Perry M et al. · The Lancet. Respiratory medicine · 2026 · PMID 41520676
- Clinical trial publication Randomised Controlled Trial Comparing Single Maintenance and Reliever Therapy (SMART) with Inhaled Budesonide-Formoterol Combination, Versus Conventional Budesonide and Additional As-Needed Levo-Salbutamol, in Children with Persistent Bronchial AsthmaBasson A, Dhawan D, Mathew JL · Indian journal of pediatrics · 2026 · PMID 41405824
- 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
- Clinical trial publication Budesonide-formoterol versus salbutamol as reliever therapy in children with mild asthma (CARE): a 52-week, open-label, multicentre, superiority, randomised controlled trialHatter L, Holliday M, Oldfield K et al. · Lancet (London, England) · 2025 · PMID 41033330
- Cochrane review Efficacy and safety profile of doxofylline in asthma: a meta-analysisGao F, Li J, Hou Y et al. · The Journal of asthma : official journal of the Association for the Care of Asthma · 2025 · PMID 39264111
- Systematic review [IS AS NEEDED THERAPY WITH AN INHALED BUDESONIDE/FORMOTEROL COMBINATION ONLY WHEN SYMPTOMATIC AS AN OPTION IN THE MANAGEMENT OF PATIENTS WITH MILD ASTHMA?]Inui T, Hira D, Takaku Y et al. · Arerugi = [Allergy] · 2025 · PMID 41083350
- Meta-analysis Effect of aerosol inhalation of budesonide on respiratory symptoms and inflammatory factors in patients with asthma: a meta-analysisXu J, Kou L, Bai D et al. · The Journal of asthma : official journal of the Association for the Care of Asthma · 2024 · PMID 38889078
- 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 Effect of Montelukast Combined with Budesonide on Inflammatory Response and Pulmonary Function in Children with Cough Variant Asthma: A Meta-analysisWu Q, Wang L, Wu M et al. · Journal of the College of Physicians and Surgeons--Pakistan : JCPSP · 2023 · PMID 37691368
- 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
- Cochrane review Single maintenance and reliever therapy in treatment of asthma exacerbationsImam SF, Zafar S, Oppenheimer JJ · Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology · 2022 · PMID 35914659
- 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 Combination fixed-dose β agonist and steroid inhaler as required for adults or children with mild asthma: a Cochrane systematic reviewCrossingham I, Turner S, Ramakrishnan S et al. · BMJ evidence-based medicine · 2022 · PMID 34282031
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 Budesonide approved for Asthma?
Budesonide 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 Budesonide in clinical trials for Asthma?
ClinicalTrials.gov lists 8 registered trials linking Budesonide to Asthma: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00641446). The largest enrolment is 12460 participants (NCT01444430). Registration activity spans 2001 to 2022.
What does the evidence show for Budesonide in Asthma?
Budesonide 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.