Summary
Olodaterol Hydrochloride 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 2 registered trials linking Olodaterol Hydrochloride to COPD: 1 is currently recruiting; 1 has completed. The most advanced is Phase 4 (NCT02799784). It plans or enrolled 236 participants. Registration activity spans 2016 to 2025. No published literature item is linked to Olodaterol Hydrochloride and COPD in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
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 | 28.0 (trials 8.0, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 1 recruiting, 0 active / not yet recruiting, 1 completed, 0 other |
| Linked publications | 0 |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02799784 | An Efficacy Study of Umeclidinium/Vilanterol With Tiotropium/Olodaterol in COPD Patients 2016 | completed | Phase 4 | 236 |
| NCT07267130 | A Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetic Profile of TQC3302 Inhalation Spray in Healthy Adult Subjects 2025 | recruiting | Phase 1 | 57 |
Published literature
No publication is linked to this pair yet.
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 Olodaterol Hydrochloride approved for COPD?
Olodaterol Hydrochloride 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 Olodaterol Hydrochloride in clinical trials for COPD?
ClinicalTrials.gov lists 2 registered trials linking Olodaterol Hydrochloride to COPD: 1 is currently recruiting; 1 has completed. The most advanced is Phase 4 (NCT02799784). It plans or enrolled 236 participants. Registration activity spans 2016 to 2025.
What does the evidence show for Olodaterol Hydrochloride in COPD?
Olodaterol Hydrochloride has 1 completed registered trial for COPD but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. 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.