Summary
Arformoterol Tartrate 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ClinicalTrials.gov lists 8 registered trials linking Arformoterol Tartrate to COPD: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00424528). The largest enrolment is 741 participants (NCT00064402). Registration activity spans 2002 to 2011. The literature layer holds 4 publications for this pair: 4 clinical trial publications. Publication years run from 2007 to 2017. 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 | 57.5 (trials 29.5, literature 8.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 4 (4 clinical 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00424528 | Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD) 2006 | completed | Phase 4 | 235 |
| NCT00571428 | Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD 2007 | completed | Phase 4 | 33 |
| NCT01361984 | Sunovion Brovana Versus Serevent Inspiratory Capacity High Resolution Computed Tomography 2011 | status unknown | Phase 4 | 20 |
| NCT00064402 | Determine the Safety and Efficacy of (R,R)-Formoterol in the Treatment of Subjects With COPD 2002 | completed | Phase 3 | 741 |
| NCT00685841 | A Pivotal Study of the Safety and Effectiveness of Arformoterol in Subjects With Chronic Obstructive Pulmonary Disease (COPD) 2002 | completed | Phase 3 | 717 |
| NCT00685529 | Study of Arformoterol Tartrate Inhalation Solution and Racemic Formoterol in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease (COPD) 2005 | completed | Phase 2 | 24 |
| NCT01391559 | Efficacy of Inhaling Bronchodilator Medications in Chronic Obstructive Pulmonary Disease 2011 | completed | Not applicable | 20 |
| NCT00846287 | Assessment of Arformoterol for Chronic Obstructive Pulmonary Disease (COPD) Using Hyperpolarized 3He MRI 2008 | completed | Not applicable | 16 |
Published literature
- Clinical trial publication Health Status of Patients with Moderate to Severe COPD after Treatment with Nebulized Arformoterol Tartrate or Placebo for 1 YearDonohue JF, Ganapathy V, Bollu V et al. · Clinical therapeutics · 2017 · PMID 28011247
- Clinical trial publication One-year safety and efficacy study of arformoterol tartrate in patients with moderate to severe COPDDonohue JF, Hanania NA, Make B et al. · Chest · 2014 · PMID 25451347
- Clinical trial publication A pharmacokinetic/pharmacodynamic study comparing arformoterol tartrate inhalation solution and racemic formoterol dry powder inhaler in subjects with chronic obstructive pulmonary diseaseKharidia J, Fogarty CM, Laforce CF et al. · Pulmonary pharmacology & therapeutics · 2008 · PMID 18501650
- Clinical trial publication Nebulized arformoterol in patients with COPD: a 12-week, multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled trialBaumgartner RA, Hanania NA, Calhoun WJ et al. · Clinical therapeutics · 2007 · PMID 17472819
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 Arformoterol Tartrate approved for COPD?
Arformoterol Tartrate 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 Arformoterol Tartrate in clinical trials for COPD?
ClinicalTrials.gov lists 8 registered trials linking Arformoterol Tartrate to COPD: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00424528). The largest enrolment is 741 participants (NCT00064402). Registration activity spans 2002 to 2011.
What does the evidence show for Arformoterol Tartrate in COPD?
Arformoterol Tartrate has 7 completed trials and 4 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.