Summary
Albuterol Sulfate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in COPD would be drug repurposing rather than first-in-human development. This does not mean it is approved for COPD. ClinicalTrials.gov lists 8 registered trials linking Albuterol Sulfate to COPD: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00379028). The largest enrolment is 1480 participants (NCT00400153). Registration activity spans 2006 to 2017. The literature layer holds 6 publications for this pair: 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2008 to 2025. These are primary trial reports rather than syntheses, so results have not yet been pooled or graded independently.
The RepurpOS disease-intelligence file for Chronic Obstructive Pulmonary Disease ranks 505 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: Effectively zero — airflow obstruction is irreversible by definition in COPD; FEV1 decline continues at 30-60 mL/year on standard care.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 63.0 (trials 30.0, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02576626 | Single Dose Ultibro Breezhaler by Sd-DPI Versus Ipratropium/Salbutamol by Nebulizer in COPD 2015 | completed | Phase 4 | 40 |
| NCT00379028 | Airway Clearance Study 2006 | completed | Phase 4 | 54 |
| NCT00400153 | Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD) 2006 | completed | Phase 3 | 1,480 |
| NCT02126839 | A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics 2014 | completed | Phase 3 | 186 |
| NCT01005901 | A Study to Assess the Safety, Tolerability and Efficacy of NVA237 Versus Placebo 2009 | completed | Phase 3 | 1,324 |
| NCT01154127 | Effect of NVA237 on Exercise Endurance in Patients With Chronic Obstructive Pulmonary Disease (COPD) 2010 | completed | Phase 3 | 108 |
| NCT03170232 | A Pilot Study of Danirixin for Disease Progression in Chronic Obstructive Pulmonary Disease (COPD) 2017 | terminated | Phase 2 | 54 |
| 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 Albuterol Digihaler in COPD Disease Management: A Real-World Study to Assess Digihaler Inhalation Parameters, Thresholds and Their Use to Identify Deterioration in Clinical PracticeFerguson GT, Boe A, Hill TD et al. · International journal of chronic obstructive pulmonary disease · 2025 · PMID 40384948
- Clinical trial publication Development of a novel digital breath-activated inhaler: Initial particle size characterization and clinical testingKesten S, Israel E, Li G et al. · Pulmonary pharmacology & therapeutics · 2018 · PMID 30201410
- 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 Randomized controlled trial of a breath-activated nebulizer in patients with exacerbation of COPDHaynes JM · Respiratory care · 2012 · PMID 22348309
- Clinical trial publication Lack of protective effect of tiotropium vs induced dynamic hyperinflation in moderate COPDGelb AF, Fraser C, Zamel N · Respiratory medicine · 2011 · PMID 21159499
- Randomized controlled trial A double-blind crossover study comparing the safety and efficacy of three weeks of Flu/Sal 250/50 bid plus albuterol 180 ug prn q4 hours to Flu/Sal 250/50 bid plus albuterol/Ipratropium bromide 2 puffs prn q4 hours in patients with chronic obstructive pulmonary diseaseBalkissoon R, Make B · COPD · 2008 · PMID 18671147
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 COPD?
Albuterol Sulfate has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in COPD would be drug repurposing rather than first-in-human development. This does not mean it is approved for COPD. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Albuterol Sulfate in clinical trials for COPD?
ClinicalTrials.gov lists 8 registered trials linking Albuterol Sulfate to COPD: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00379028). The largest enrolment is 1480 participants (NCT00400153). Registration activity spans 2006 to 2017.
What does the evidence show for Albuterol Sulfate in COPD?
Albuterol Sulfate has 7 completed trials and 6 linked publications for COPD. 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.