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NCT04678206: SOOTHE
Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough
Completed
Phase 2
Last updated 13 December 2021
What this trial tests
Phase 2 trial testing BLU-5937 in Refractory Chronic Cough in 310 participants. Completed in 2 November 2021.
Timeline
7 December 2020
Primary endpoint
21 October 2021
21 October 2021
2 November 2021
Quick facts
| Lead sponsor | Bellus Health Inc. - a GSK company |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 310 |
| Start date | 7 December 2020 |
| Primary completion | 21 October 2021 |
| Estimated completion | 2 November 2021 |
| Sites | 116 locations across United Kingdom, Germany, Hungary, Poland, Canada, United States, Czechia |
Drugs / interventions tested
- BLU-5937 — full drug profile →
- Placebo
Conditions studied
- Refractory Chronic Cough — all drugs for Refractory Chronic Cough →
Sponsor
Bellus Health Inc. - a GSK company — full company profile →
Who can join
Adults 18 to 80, any sex, with Refractory Chronic Cough. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a randomized, double-blind, placebo-controlled, parallel-arm, Phase 2b adaptive dose-finding study of BLU-5937 in participants with Refractory Chronic Cough (RCC).
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Camlipixant in Refractory Chronic Cough: A Phase 2b, Randomized, Placebo-controlled Trial (SOOTHE).
Smith JA, Birring SS, Blaiss MS, McGarvey L, et al · · 2025 · cited 13× · PMID 40043302 · DOI 10.1164/rccm.202409-1752oc -
From bench to bedside: The role of cough hypersensitivity in chronic cough.
Drake MG, McGarvey LP, Morice AH. · · 2023 · cited 13× · PMID 37501282 · DOI 10.1002/ctm2.1343 -
The developmental journey of therapies targeting purine receptors: from basic science to clinical trials.
Han S, Suzuki-Kerr H, Vlajkovic SM, Thorne PR. · · 2022 · cited 9× · PMID 36173587 · DOI 10.1007/s11302-022-09896-w -
Camlipixant in Refractory Chronic Cough: A Phase 2a, Randomized Controlled Trial (RELIEF).
Smith JA, Morice AH, Birring SS, Parker SM, et al · · 2025 · cited 6× · PMID 40043304 · DOI 10.1164/rccm.202501-0093rl -
Decoding the impact of the placebo response in clinical trials for chronic cough.
Zhang M, Zhang B, Morice AH. · · 2024 · cited 6× · PMID 39469270 · DOI 10.1183/23120541.00335-2024 -
Reply to Zeng: the SOOTHE trial of camlipixant in RCC: a cautionary note on stratification and relevance.
Smith JA. · · 2026 · PMID 41052428 · DOI 10.1164/rccm.202507-1640le -
Reply to Rui and Chen: Initial Success: Camlipixant in Refractory Chronic Cough.
Smith JA. · · 2025 · PMID 40479589 · DOI 10.1164/rccm.202504-0861le
Verify or expand the search:
- PubMed search for NCT04678206
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of BLU-5937
Trials testing the same drug.
- NCT05600777 — A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough · Phase 3 · active not recruiting
- NCT05599191 — A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough · Phase 3 · active not recruiting
- NCT06179537 — Evaluation of the Pharmacokinetics and Safety of BLU-5937 in Healthy Adult Japanese and Caucasian Subjects · Phase 1 · completed
- NCT04693195 — A Multiple-Dose Study of BLU-5937 in Chronic Pruritus Associated With Atopic Dermatitis · Phase 2 · completed
- NCT03979638 — A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough · Phase 2 · terminated
Other recruiting trials for Refractory Chronic Cough
Currently open trials in the same condition.
- NCT06706765 — Group Telehealth Behavioral Cough Suppression Therapy · EARLY_PHASE1 · recruiting
- NCT05600777 — A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough · Phase 3 · active not recruiting
- NCT05599191 — A 52-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough · Phase 3 · active not recruiting
Other Bellus Health Inc. - a GSK company trials
Trials by the same sponsor.
- NCT06497517 — A Study to Investigate the Effect of Food on Camlipixant Concentrations in Healthy Participants · Phase 1 · completed
- NCT06222892 — A Study of Camlipixant in Male and Female Healthy Participants and Participants With Hepatic Impairment Aged 18-75 Years · Phase 1 · completed
- NCT05959447 — Evaluation of the Potential Drug-drug Interactions Between Gemfibrozil or Dabigatran Etexilate and Camlipixant · Phase 1 · completed
- NCT05899829 — Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant · Phase 1 · completed
- NCT05600777 — A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough · Phase 3 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04678206 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Bellus Health Inc. - a GSK company
- Last refreshed: 13 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04678206.
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