Summary
Indacaterol Maleate 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 ClinicalTrials.gov lists 8 registered trials linking Indacaterol Maleate to COPD: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02125734). The largest enrolment is 357 participants (NCT02487446). Registration activity spans 2008 to 2024. The literature layer holds 4 publications for this pair: 4 clinical trial publications. Publication years run from 2013 to 2020. 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 | 57.0 (trials 29.0, literature 8.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 6 completed, 2 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01437748 | Closing Volume Interpretation and Bronchodilators Effect 2011 | completed | Phase 4 | 40 |
| NCT02125734 | Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients 2014 | completed | Phase 4 | 88 |
| NCT02442206 | Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients 2015 | completed | Phase 4 | 62 |
| NCT02487446 | Efficacy and Safety Study of QVA149 in COPD Patients 2015 | completed | Phase 3 | 357 |
| NCT01529632 | Comparison of Safety and Efficacy of the Combination Product QVA149A Against the Concurrent Administration of the Individual Components, QAB149 and NVA237, in Patients With Chronic Obstructive Pulmonary Disease (COPD) 2012 | completed | Phase 3 | 193 |
| NCT03379233 | A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence 2018 | terminated | Phase 3 | 7 |
| NCT00636961 | An Exploratory Study, to Assess the Effect of Repeat-dose Inhaled Indacaterol Maleate (300 μg) on Dynamic and Static Lung Hyperinflation, Subjective Breathlessness and Health Status in Patients With Chronic Obstructive Pulmonary Disease(COPD) 2008 | completed | Phase 2 | 27 |
| NCT07541378 | Comparative Efficacy of Once-daily LAMA/LABA Combinations Versus Tiotropium on Constant-work-rate Cycle Endurance in COPD 2024 | suspended | Not applicable | 100 |
Published literature
- Clinical trial publication Bioequivalence studies of inhaled indacaterol maleate in healthy Chinese volunteers under gastrointestinal non-blocking or blocking with concomitant charcoal administrationZou C, Yang Q, Yang S et al. · Pulmonary pharmacology & therapeutics · 2020 · PMID 32045673
- Clinical trial publication Dual Bronchodilation with Indacaterol Maleate/Glycopyrronium Bromide Compared with Umeclidinium Bromide/Vilanterol in Patients with Moderate-to-Severe COPD: Results from Two Randomized, Controlled, Cross-over StudiesKerwin E, Ferguson GT, Sanjar S et al. · Lung · 2017 · PMID 28993871
- Clinical trial publication Indacaterol and glycopyrronium versus indacaterol on body plethysmography measurements in COPD-a randomised controlled studySalomon J, Stolz D, Domenighetti G et al. · Respiratory research · 2017 · PMID 28077140
- Clinical trial publication The effect of indacaterol during an acute exacerbation of COPDSegreti A, Fiori E, Calzetta L et al. · Pulmonary pharmacology & therapeutics · 2013 · PMID 23578980
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 Indacaterol Maleate approved for COPD?
Indacaterol Maleate 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 Indacaterol Maleate in clinical trials for COPD?
ClinicalTrials.gov lists 8 registered trials linking Indacaterol Maleate to COPD: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT02125734). The largest enrolment is 357 participants (NCT02487446). Registration activity spans 2008 to 2024.
What does the evidence show for Indacaterol Maleate in COPD?
Indacaterol Maleate has 6 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.