Summary
Tiotropium Bromide 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 ClinicalTrials.gov lists 8 registered trials linking Tiotropium Bromide to COPD: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01465906). The largest enrolment is 983 participants (NCT00168844). Registration activity spans 2003 to 2023. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2009 to 2026. 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, 6 completed, 2 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01656005 | Beta Blocker Therapy in Moderate to Severe COPD 2012 | completed | Phase 4 | 18 |
| NCT01465906 | Efficacy and Safety of Tulobuterol Patch Combined With Tiotropium Bromide for Relieving Dyspnea Symptom of Chronic Obstructive Pulmonary Disease 2010 | status unknown | Phase 4 | 160 |
| NCT01462929 | Efficacy and Safety of Aclidinium Bromide 400 µg Compared to Placebo and to Tiotropium Bromide in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) 2011 | completed | Phase 3 | 414 |
| NCT05161156 | Bioequivalence Study of Tiotropium Bromide Inhalation Powder 2022 | completed | Phase 3 | 306 |
| NCT00168844 | Tiotropium / Respimat One-Year Study 2003 | completed | Phase 3 | 983 |
| NCT02347072 | 24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003, Open-Label Spiriva® Respimat® as an Active Control, and Placebo 2015 | completed | Phase 3 | 80 |
| NCT03084796 | A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease 2017 | completed | Phase 2 | 733 |
| NCT05748977 | Short Acting Agents Vs Long Acting in Frequent Excerbator COPD Patients 2023 | status unknown | Early Phase 1 | 80 |
Published literature
- Clinical trial publication A multicenter randomized controlled trial and metabolomics exploration of Traditional Chinese Medicine pattern-based therapy for stable chronic obstructive pulmonary diseaseHuanzhang D, Hui W, Qinjun Y et al. · Journal of traditional Chinese medicine = Chung i tsa chih ying wen pan · 2026 · PMID 42365412
- Clinical trial publication A placebo-controlled, crossover trial to investigate the efficacy of tiotropium bromide or placebo added to usual care in stable symptomatic post-hematopoietic stem cell transplantation (HSCT) bronchiolitis obliterans syndrome (BOS)Dini N, Khoshbin AP, Aliannejad R et al. · Trials · 2024 · PMID 38582877
- Clinical trial publication Tiotropium Bromide Attenuates Mucus Hypersecretion in Patients with Stable Chronic Obstructive Pulmonary DiseaseYu S, Zhang C, Yan Z et al. · Computational and mathematical methods in medicine · 2021 · PMID 34650619
- Clinical trial publication Pharmacokinetics and safety of tiotropium+olodaterol 5 μg/5 μg fixed-dose combination in Chinese patients with COPDWang Z, Tadayasu Y, Hu N et al. · Pulmonary pharmacology & therapeutics · 2020 · PMID 32916296
- Cochrane review [Systematic review and Meta-analysis on efficacy and safety of Buzhong Yiqi Decoction for stable chronic obstructive pulmonary disease]Yi-Ling F, Qing M, Xing L et al. · Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica · 2020 · PMID 33350193
- Clinical trial publication Clinical benefit of two-times-per-day aclidinium bromide compared with once-a-day tiotropium bromide hydrate in COPD: a multicentre, open-label, randomised studyKamei T, Nakamura H Dr, Nanki N Dr et al. · BMJ open · 2019 · PMID 31350236
- Randomized controlled trial Inhaled Glucocorticoid with or without Tiotropium Bromide for Asthma-Chronic Obstructive Pulmonary Disease Overlap SyndromeXu H, Lu X · Journal of the College of Physicians and Surgeons--Pakistan : JCPSP · 2019 · PMID 30823952
- Meta-analysis Long-acting muscarinic antagonists vs. long-acting β 2 agonists in COPD exacerbations: a systematic review and meta-analysisMaia IS, Pincelli MP, Leite VF et al. · Jornal brasileiro de pneumologia : publicacao oficial da Sociedade Brasileira de Pneumologia e Tisilogia · 2017 · PMID 28767773
- Cochrane review Comparative mortality risk of tiotropium administered via handihaler or respimat in COPD patients: are they equivalent?Mathioudakis AG, Chatzimavridou-Grigoriadou V, Evangelopoulou E et al. · Pulmonary pharmacology & therapeutics · 2014 · PMID 24846455
- Cochrane review Combination inhaled steroid and long-acting beta2-agonist versus tiotropium for chronic obstructive pulmonary diseaseWelsh EJ, Cates CJ, Poole P · The Cochrane database of systematic reviews · 2013 · PMID 23728670
- Meta-analysis Comparative efficacy of long-acting bronchodilators for COPD: a network meta-analysisCope S, Donohue JF, Jansen JP et al. · Respiratory research · 2013 · PMID 24093477
- Cochrane review Tiotropium versus long-acting beta-agonists for stable chronic obstructive pulmonary diseaseChong J, Karner C, Poole P · The Cochrane database of systematic reviews · 2012 · PMID 22972134
- Cochrane review The cardiovascular risk of tiotropium: is it real?Cazzola M, Calzetta L, Matera MG · Expert opinion on drug safety · 2010 · PMID 20565229
- Meta-analysis Tiotropium and risk for fatal and nonfatal cardiovascular events in patients with chronic obstructive pulmonary disease: systematic review with meta-analysisRodrigo GJ, Castro-Rodriguez JA, Nannini LJ et al. · Respiratory medicine · 2009 · PMID 19556116
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 Tiotropium Bromide approved for COPD?
Tiotropium Bromide 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 Tiotropium Bromide in clinical trials for COPD?
ClinicalTrials.gov lists 8 registered trials linking Tiotropium Bromide to COPD: 6 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT01465906). The largest enrolment is 983 participants (NCT00168844). Registration activity spans 2003 to 2023.
What does the evidence show for Tiotropium Bromide in COPD?
Tiotropium Bromide 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.