Summary
Albuterol 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 ClinicalTrials.gov lists 8 registered trials linking Albuterol to COPD: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status.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 12 publications for this pair: 3 Cochrane reviews, 2 meta-analyses, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2001 to 2025. 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 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 | 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, 7 completed, 1 other |
| Linked publications | 12 (5 clinical trial publications, 3 Cochrane reviews, 2 meta-analyses, 2 randomised controlled trial publications) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 Predictive machine learning algorithm for COPD exacerbations using a digital inhaler with integrated sensorsSnyder LD, DePietro M, Reich M et al. · BMJ open respiratory research · 2025 · PMID 40355297
- Clinical trial publication Effect of twice daily inhaled albuterol on cardiopulmonary exercise outcomes, dynamic hyperinflation, and symptoms in secondhand tobacco-exposed persons with preserved spirometry and air trapping: a randomized controlled trialZeng S, Nishihama M, Weldemichael L et al. · BMC pulmonary medicine · 2024 · PMID 38245665
- Clinical trial publication The Effect of Albuterol Spray on Hypoxia and Bronchospasm in Patients with Chronic Obstructive Pulmonary Disease (COPD) under General Anesthesia: A bouble-Blind Randomized Clinical TrialMaddah SA, Barzegari A · Ethiopian journal of health sciences · 2023 · PMID 37576161
- Clinical trial publication Improvements in lung function with budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler versus dual therapies in patients with COPD: a sub-study of the ETHOS trialRabe KF, Martinez FJ, Singh D et al. · Therapeutic advances in respiratory disease · 2021 · PMID 34428980
- Randomized controlled trial Efficacy and Safety of Once-Daily Inhaled Umeclidinium in Asian Patients with COPD: Results from a Randomized, Placebo-Controlled StudyZhong N, Zheng J, Lee SH et al. · International journal of chronic obstructive pulmonary disease · 2020 · PMID 32368027
- Randomized controlled trial Nebulized heparin and salbutamol versus salbutamol alone in acute exacerbations of chronic obstructive pulmonary disease requiring mechanical ventilation: a double-blind randomized controlled trialAshoor TM, Hasseb AM, Esmat IM · Korean journal of anesthesiology · 2020 · PMID 32106642
- Meta-analysis Impact of prior and concurrent medication on exacerbation risk with long-acting bronchodilators in chronic obstructive pulmonary disease: a post hoc analysisNaya I, Tombs L, Lipson DA et al. · Respiratory research · 2019 · PMID 30914064
- Cochrane review Umeclidinium Plus Vilanterol Versus Placebo, Umeclidinium, or Vilanterol Monotherapies for Chronic Obstructive Pulmonary Disease: A Meta-Analysis of Randomized Controlled TrialsWang L, Zhai CJ, Liu Y et al. · Clinical drug investigation · 2016 · PMID 27539612
- Meta-analysis Bronchodilator efficacy and safety of indacaterol 150 μg once daily in patients with COPD: an analysis of pooled dataBleecker ER, Siler T, Owen R et al. · International journal of chronic obstructive pulmonary disease · 2011 · PMID 22003288
- Cochrane review Heliox for treatment of exacerbations of chronic obstructive pulmonary diseaseRodrigo G, Pollack C, Rodrigo C et al. · The Cochrane database of systematic reviews · 2002 · PMID 12076487
- Cochrane review Inhaled short-acting beta2-agonists versus ipratropium for acute exacerbations of chronic obstructive pulmonary diseaseMcCrory DC, Brown CD · The Cochrane database of systematic reviews · 2001 · PMID 11406052
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 approved for COPD?
Albuterol 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 in clinical trials for COPD?
ClinicalTrials.gov lists 8 registered trials linking Albuterol 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 in COPD?
Albuterol has both completed registered trials and synthesis-level publications linked to COPD. 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.