Summary
Albuterol Sulfate 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 ClinicalTrials.gov lists 8 registered trials linking Albuterol Sulfate to Asthma: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00529529). It plans or enrolled 805 participants. Registration activity spans 2000 to 2016. The literature layer holds 6 publications for this pair: 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2000 to 2021. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
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 | 62.0 (trials 29.0, literature 13.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 6 (5 clinical trial publications, 1 randomised controlled trial publication) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02126839 | A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics 2014 | completed | Phase 3 | 186 |
| NCT00529529 | Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma 2007 | completed | Phase 3 | 805 |
| NCT00667407 | Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma 2000 | completed | Phase 3 | 627 |
| NCT00200967 | Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE) 2004 | completed | Phase 3 | 87 |
| NCT02479412 | A Multiple Dosing (14 Days) Study to Assess Efficacy and Safety of Three Dose Levels of AZD7594, Given Once Daily by Inhalation, in Patients With Mild to Moderate Asthma 2015 | completed | Phase 2 | 54 |
| NCT00096616 | Combivent® CFC Metered Dose Inhaler (MDI) in Moderate to Severe Asthma 2004 | completed | Phase 2 | 113 |
| NCT02794519 | A Phase 2a Study to Evaluate the Effects of Sirukumab in Subjects With Severe Poorly Controlled Asthma 2016 | withdrawn | Phase 2 | — |
| NCT01302587 | A Study to Evaluate the Integrated Dose Counter on an Albuterol Hydrofluoroalkane (HFA) Metered Dose Inhaler (MDI) 2011 | completed | Not applicable | 306 |
Published literature
- Clinical trial publication Dose-Ranging and Cumulative Dose Studies of Albuterol Sulfate MDI in Co-Suspension Delivery™ Technology (AS MDI; PT007) in Patients with Asthma: the ASPEN and ANTORA TrialsCappelletti C, Maes A, Rossman K et al. · Clinical drug investigation · 2021 · PMID 34089147
- Clinical trial publication Effect of heliox- and air-driven nebulized bronchodilator therapy on lung function in patients with asthmaEl-Khatib MF, Jamaleddine G, Kanj N et al. · Lung · 2014 · PMID 24643901
- Clinical trial publication Prospective, open-label assessment of albuterol sulfate hydrofluoroalkane metered-dose inhaler with new integrated dose counterGiven J, Taveras H, Iverson H et al. · Allergy and asthma proceedings · 2013 · PMID 23265285
- Clinical trial publication The effect of heliox-driven bronchodilator aerosol therapy on pulmonary function tests in patients with asthmaBag R, Bandi V, Fromm RE Jr et al. · The Journal of asthma : official journal of the Association for the Care of Asthma · 2002 · PMID 12442956
- Clinical trial publication Long-acting beta2-agonist monotherapy vs continued therapy with inhaled corticosteroids in patients with persistent asthma: a randomized controlled trialLazarus SC, Boushey HA, Fahy JV et al. · JAMA · 2001 · PMID 11368732
- Randomized controlled trial Clinical comparability of ventolin formulated with hydrofluoroalkane or conventional chlorofluorocarbon propellants in children with asthmaShapiro G, Bronsky E, Murray A et al. · Archives of pediatrics & adolescent medicine · 2000 · PMID 11115306
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 Albuterol Sulfate approved for Asthma?
Albuterol Sulfate 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 Albuterol Sulfate in clinical trials for Asthma?
ClinicalTrials.gov lists 8 registered trials linking Albuterol Sulfate to Asthma: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00529529). It plans or enrolled 805 participants. Registration activity spans 2000 to 2016.
What does the evidence show for Albuterol Sulfate in Asthma?
Albuterol Sulfate has 7 completed trials and 6 linked publications for Asthma. Completed trials may or may not have posted results; follow the NCT links to check. 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.