Summary
Nicotine 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 Nicotine to COPD: 1 is currently recruiting; 7 have completed. The most advanced is Phase 3 (NCT02148445). The largest enrolment is 1500 participants (NCT05919511). Registration activity spans 2014 to 2023. The literature layer holds 15 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 2 systematic reviews and 5 clinical trial publications. Publication years run from 2004 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 | 73.5 (trials 23.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 0 active / not yet recruiting, 7 completed, 0 other |
| Linked publications | 15 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 2 systematic reviews) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
| Linked via biomarker / target | ADCY5 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02148445 | Smoking Cessation Versus Long-term Nicotine Replacement Among High-risk Smokers 2014 | completed | Phase 3 | 398 |
| NCT05610514 | Pulmonary and Cardiac Effects of E-Cigarette Use in Pulmonary Patients Who Smoke Cigarettes 2022 | completed | Phase 2 | 21 |
| NCT05374629 | Study on the Effect of Smoking Cessation in COPD Patients After Shared Decision Making Intervention 2020 | completed | Not applicable | 88 |
| NCT04043728 | Addressing Psychological Risk Factors Underlying Smoking Persistence in COPD Patients: The Fresh Start Study 2019 | completed | Not applicable | 18 |
| NCT02612389 | Meditative Movement for COPD Symptoms in Non-Smoking Flight Attendants 2015 | completed | Not applicable | 220 |
| NCT02892396 | Influence of Electronic Cigarettes in the Evaluation of the Inflammatory Response in Patients With a Diagnosis of COPD 2016 | completed | Not applicable | 10 |
| NCT04223362 | PICk-UP: PersonalIsed CommUnity-based Physical Activities for Patients With Chronic Obstructive Pulmonary Disease 2020 | completed | Not applicable | 61 |
| NCT05919511 | Observational Study for Patients at Risk for Chronic Graft-Versus-Host Disease 2023 | recruiting | Not applicable | 1,500 |
Published literature
- Clinical trial publication Impact of the POPulation Medicine Multimorbidity Intervention in Xishui County (POPMIX) on people at high risk for COPD who smoke: protocol for the POPMIX-Smoking cluster randomised controlled trialChen S, Huang K, Zheng Z et al. · BMJ open · 2026 · PMID 42091148
- Clinical trial publication Cardiopulmonary effects of combustible cigarettes and e-cigarettes in individuals with chronic obstructive pulmonary diseaseKatz BR, Menson KE, Medina N et al. · Experimental and clinical psychopharmacology · 2026 · PMID 41343367
- Clinical trial publication Cytisinicline for smoking cessation in individuals with self-reported COPD: a post hoc analysis of the ORCA-2 and ORCA-3 trialsProchaska J, Rubinstein M, Perdok R et al. · Thorax · 2026 · PMID 40962497
- Clinical trial publication E-cigarette puff topography instruction to enhance switching among COPD patients who smokeLeavens ELS, Wagener TL, Lambart L et al. · Frontiers in public health · 2025 · PMID 41112651
- Meta-analysis Assessing the impact of electronic nicotine delivery systems on chronic obstructive pulmonary disease: A systematic review and meta-analysisMalvi A, Khatib MN, Ganesan S et al. · Respiratory medicine · 2025 · PMID 40157397
- Clinical trial publication Switching to E-cigarettes as Harm Reduction Among Individuals With Chronic Disease Who Currently Smoke: Results of a Pilot Randomized Controlled TrialVojjala M, Stevens ER, Nicholson A et al. · Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco · 2024 · PMID 38995184
- Cochrane review The effectiveness of theory-based smoking cessation interventions in patients with chronic obstructive pulmonary disease: a meta-analysisHan M, Fu Y, Ji Q et al. · BMC public health · 2023 · PMID 37559043
- Meta-analysis Tar level of cigarettes smoked and risk of smoking-related diseasesLee PN · Inhalation toxicology · 2018 · PMID 29488428
- Cochrane review Smoking cessation for people with chronic obstructive pulmonary diseasevan Eerd EA, van der Meer RM, van Schayck OC et al. · The Cochrane database of systematic reviews · 2016 · PMID 27545342
- Cochrane review Smoking cessation for patients with chronic obstructive pulmonary disease (COPD): an evidence-based analysisThabane M, COPD Working Group · Ontario health technology assessment series · 2012 · PMID 23074432
- Meta-analysis Multiple independent loci at chromosome 15q25.1 affect smoking quantity: a meta-analysis and comparison with lung cancer and COPDSaccone NL, Culverhouse RC, Schwantes-An TH et al. · PLoS genetics · 2010 · PMID 20700436
- Systematic review Systematic review of the evidence relating FEV1 decline to giving up smokingLee PN, Fry JS · BMC medicine · 2010 · PMID 21156048
- Cochrane review [Smoking cessation with special focus on primary health care]Bredesen H, Lous J · Ugeskrift for laeger · 2009 · PMID 19257992
- Cochrane review Grey lungs and blue moods: smoking cessation in the context of lifetime depression historyWilhelm K, Arnold K, Niven H et al. · The Australian and New Zealand journal of psychiatry · 2004 · PMID 15555023
- Systematic review The efficacy of smoking cessation strategies in people with chronic obstructive pulmonary disease: results from a systematic reviewWagena EJ, van der Meer RM, Ostelo RJ et al. · Respiratory medicine · 2004 · PMID 15338790
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, in this case via the biomarker or target ADCY5. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Nicotine approved for COPD?
Nicotine 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 Nicotine in clinical trials for COPD?
ClinicalTrials.gov lists 8 registered trials linking Nicotine to COPD: 1 is currently recruiting; 7 have completed. The most advanced is Phase 3 (NCT02148445). The largest enrolment is 1500 participants (NCT05919511). Registration activity spans 2014 to 2023.
What does the evidence show for Nicotine in COPD?
Nicotine 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, in this case via the biomarker or target ADCY5. 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.