Summary
Salmeterol Xinafoate 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 Salmeterol Xinafoate to Asthma: 8 have completed. The most advanced is Phase 4 (NCT00452348). The largest enrolment is 805 participants (NCT00529529). Registration activity spans 2003 to 2014. The literature layer holds 12 publications for this pair: 2 Cochrane reviews, 3 meta-analyses, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2001 to 2020. 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 | 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, 8 completed, 0 other |
| Linked publications | 12 (5 clinical trial publications, 3 meta-analyses, 2 Cochrane reviews, 1 systematic review, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02388373 | A Guideline Approach to Therapy Step-down Utilising Flutiform Change and Step-down 2014 | completed | Phase 4 | 225 |
| NCT00169546 | Study In Airway Physiology In Children SERETIDE DISKUS ® Inhlaer and FLIXOTIDE® Inhaler Are Trademarks of GSK Group of Companies. 2003 | completed | Phase 4 | 64 |
| NCT00452348 | A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients With Asthma 2007 | completed | Phase 4 | 628 |
| NCT00529529 | Safety of Indacaterol in Patients (≥ 12 Years) With Moderate to Severe Persistent Asthma 2007 | completed | Phase 3 | 805 |
| NCT00200967 | Asthma Clinical Research Network (ACRN) Trial - Long-Acting Beta Agonist Response by Genotype (LARGE) 2004 | completed | Phase 3 | 87 |
| NCT02251379 | Environmental Control as Add-on Therapy in Childhood Asthma 2014 | completed | Phase 2 | 155 |
| NCT00364442 | Repeat Dose Study of Fluticasone Propionate/Salmeterol Versus Fluticasone Propionate + Salmeterol In Asthmatics 2005 | completed | Phase 1 | 12 |
| NCT05459194 | Efficacy and Safety Study of Fluticasone/Salmeterol Administered With Elpenhaler 2008 | completed | Not applicable | 42 |
Published literature
- Clinical trial publication Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 studyvan Zyl-Smit RN, Krüll M, Gessner C et al. · The Lancet. Respiratory medicine · 2020 · PMID 32653075
- Clinical trial publication The efficacy and safety of fluticasone/salmeterol compared to fluticasone in children younger than four years of ageYoshihara S, Tsubaki T, Ikeda M et al. · Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology · 2019 · PMID 30556939
- Clinical trial publication Video education versus face-to-face education on inhaler technique for patients with well-controlled or partly-controlled asthma: A phase IV, open-label, non-inferiority, multicenter, randomized, controlled trialPark HJ, Byun MK, Kwon JW et al. · PloS one · 2018 · PMID 30067737
- Clinical trial publication Pharmacokinetic analysis of inhaled salmeterol in asthma patients: Evidence from two dry powder inhalersSoulele K, Macheras P, Karalis V · Biopharmaceutics & drug disposition · 2017 · PMID 28374512
- Clinical trial publication A Randomized Pragmatic Trial of Changing to and Stepping Down Fluticasone/Formoterol in AsthmaUsmani OS, Kemppinen A, Gardener E et al. · The journal of allergy and clinical immunology. In practice · 2017 · PMID 28351782
- Randomized controlled trial Clinical Bioequivalence of OT329 SOLIS and ADVAIR DISKUS in Adults with AsthmaLongphre MV, Getz EB, Fuller R · Annals of the American Thoracic Society · 2017 · PMID 27849125
- Meta-analysis COST-effectiveness of salmeterol/fluticasone propionate combination (Advair(®)) in uncontrolled asthma in CanadaIsmaila AS, Risebrough N, Li C et al. · Respiratory medicine · 2014 · PMID 25175480
- Systematic review Inhaled corticosteroids or long-acting beta-agonists alone or in fixed-dose combinations in asthma treatment: a systematic review of fluticasone/budesonide and formoterol/salmeterolFrois C, Wu EQ, Ray S et al. · Clinical therapeutics · 2009 · PMID 20110019
- Meta-analysis Cost-effectiveness of salmeterol xinafoate/fluticasone propionate combination inhaler in chronic asthmaDoull I, Price D, Thomas M et al. · Current medical research and opinion · 2007 · PMID 17519082
- Cochrane review Inhaled long acting beta agonists for stable chronic asthmaWalters EH, Walters JA, Gibson MD · The Cochrane database of systematic reviews · 2003 · PMID 14583933
- Cochrane review Regular treatment with long acting beta agonists versus daily regular treatment with short acting beta agonists in adults and children with stable asthmaWalters EH, Walters JA, Gibson PW · The Cochrane database of systematic reviews · 2002 · PMID 12519616
- Meta-analysis Comparison of inhaled salmeterol and oral zafirlukast in asthmatic patients using concomitant inhaled corticosteroidsNelson HS, Nathan RA, Kalberg C et al. · MedGenMed : Medscape general medicine · 2001 · PMID 11549982
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 Salmeterol Xinafoate approved for Asthma?
Salmeterol Xinafoate 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 Salmeterol Xinafoate in clinical trials for Asthma?
ClinicalTrials.gov lists 8 registered trials linking Salmeterol Xinafoate to Asthma: 8 have completed. The most advanced is Phase 4 (NCT00452348). The largest enrolment is 805 participants (NCT00529529). Registration activity spans 2003 to 2014.
What does the evidence show for Salmeterol Xinafoate in Asthma?
Salmeterol Xinafoate 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.