BLU-5937 for Refractory Chronic Cough: 24-Week Test in Adults (China Extension)
Official title: A Phase 3, 24-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Efficacy and Safety Study With Open-label Extension of BLU-5937 in Adult Participants With Refractory Chronic Cough Including Unexplained Chronic Cough (CALM-2) - China Extension
Run by GlaxoSmithKline · NCT07650084 · Data updated 2026-11-12
This study tests whether BLU-5937 can reduce 24-hour cough frequency in adults with refractory or unexplained chronic cough.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Locations | 38 sites (Leshan, Sichuan and 37 other locations) |
| Status | Recruiting |
| Started | November 21, 2025 |
| Main results expected | August 27, 2027 |
| Study ends | June 2, 2028 |
| Registry record updated | June 16, 2026 |
| Trial ID | NCT07650084 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates have a chronic cough lasting at least one year that has not responded to prior therapies and meet study eligibility.
✕Probably not a fit
Patients with certain respiratory conditions, recent respiratory infection, or heavy smoking history may not benefit and could be excluded from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 3, randomized, double-blind, placebo-controlled trial comparing BLU-5937 to placebo in adults with chronic cough that has not improved with other treatments. Participants are assigned to BLU-5937 or placebo for 24 weeks, with the main outcome being change in 24-hour cough frequency. The trial follows a parallel-arm design to evaluate efficacy and safety in the target population. The China extension expands sites to additional investigational locations under the lead sponsor, GlaxoSmithKline.
Why it matters
Potential benefit: If successful, participants may experience fewer daily coughs and improved quality of life.
How similar studies have gone: Previous studies of similar agents in chronic cough have shown potential benefits, supporting further evaluation in a Phase 3 setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Capable of giving signed informed consent * Refractory chronic cough (including unexplained chronic cough) for at least one year * Women of child-bearing potential must use a highly effective contraception method during the study and for at least 14 days after the last dose Exclusion Criteria: * Current smoker/vaper (all forms of smoking and inhaled substances, including, cannabis/tobacco smoke and nicotine vapors) or individuals who have given up smoking within the past 6 months, or those with \>20 pack-year smoking history * Diagnosis of chronic obstructive pulmonary disease, bronchiectasis, chronic bronchitis, cystic fibrosis, pulmonary sarcoidosis, idiopathic pulmonary fibrosis, uncontrolled asthma, or other significant or progressive airway/respiratory disorder that might affect cough based on clinician assessment * Respiratory tract infection within 4 weeks before screening * Laboratory confirmed Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection at screening * History of malignancy in the last 5 years * History of alcohol or drug abuse within the last 3 years * Has a positive serologic test for human immunodeficiency virus (HIV), hepatitis B virus surface antigen, or hepatitis C virus. * Previous participation in a BLU-5937 trial
Where it's running
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Leshan, Sichuan, China Recruiting -
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Beijing, China Recruiting -
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Changsha, China Recruiting -
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Chengdu, China Recruiting -
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Chengdu, China Recruiting -
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Chongqing, China Recruiting
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Dongguan, China Recruiting -
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Ganzhou, China Recruiting -
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Guangzhou, China Recruiting -
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Guangzhou, China Recruiting -
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Guilin, China Recruiting -
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Hangzhou, China Recruiting -
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Hefei, China Recruiting -
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Hefei, China Recruiting -
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Hohhot, China Recruiting -
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Huizhou, China Recruiting -
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Huizhou, China Recruiting -
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Jiangsu, China Recruiting -
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Jinan, China Recruiting -
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Kunming, China Recruiting -
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Liuzhou, China Recruiting -
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Meizhou, China Recruiting -
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Nanchang, China Recruiting -
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Pingxiang, China Recruiting -
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Shanghai, China Recruiting -
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Shanghai, China Recruiting -
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Shanghai, China Recruiting -
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Shenyang, China Recruiting -
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Shenzhen, China Recruiting -
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Taizhou, China Recruiting -
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Ürümqi, China Recruiting -
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Weifang, China Recruiting -
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Wuxi, China Recruiting -
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Xiamen, China Recruiting -
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Yangzhou, China Recruiting -
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Yinchuan, China Recruiting -
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Zhanjiang, China Recruiting -
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Zhengzhou, China Recruiting
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Nalbuphine ER for chronic cough in people with RCC
This study tests whether extended-release nalbuphine helps people with unexplained, long-standing cough that hasn’t improved with other treatments.
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Cough Management app for refractory or unexplained chronic cough
This trial will see if using a smartphone Cough Management program plus a smartwatch for four weeks lowers coughing and improves quality of life in adults 21–80 with refractory or unexplained chronic cough.
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Behavioral Cough Suppression Therapy with or without an inhaled aid for refractory chronic cough
This study tests whether adding an inhaled substance to behavioral cough suppression helps people with persistent chronic cough see if it works better than behavior therapy alone.
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Testing Duloxetine and Amitriptyline for Chronic Cough Relief
This study is testing if two medications, Duloxetine and Amitriptyline, can help people with a stubborn chronic cough feel better.
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Magnesium spray for refractory or unexplained chronic cough in adults
A small study tests SC0032, a magnesium salt spray you spray in your mouth, to see if it reduces coughing compared with a placebo in adults with RCC or UCC.
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Chronic Cough and Airway Remodelling in Refractory Cough Patients
This study tests whether long-lasting chronic cough damages and remodels the airways in adults who have had cough for over a year and have not responded to prior treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.