A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough - China Extension

Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT07650084

Acronym / sponsor ID

CALM-2 / 221851-CHN

Conditions

Refractory Chronic Cough

Keywords

Cough, Chronic Cough

Phase

Phase 3

Study type

Interventional

Recruitment status

Recruiting

Enrolment

75 participants (estimated)

Lead sponsor

GlaxoSmithKlineIndustry (pharma, biotech, devices)

Study start

21 Nov 2025 (actual)

Primary completion

27 Aug 2027 (estimated)

Study completion

2 Jun 2028 (estimated)

First posted

16 Jun 2026 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Quadruple blind (participant, care provider, investigator, outcomes assessor)

Number of arms

3

Who may qualify

Ages

18 to 80 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

1. 24-Hour Cough Frequency

   Time frame: Week 24

   Assessed using an ambulatory cough monitor

2. Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to Week 24

   Time frame: Up to Week 24

   An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

3. Number of Participants with Adverse Events of Medical Interest (AEMIs) up to Week 24

   Time frame: Up to Week 24

   An AEMI is an event of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring is appropriate. The following are AEMIs for this study: taste disturbance, oral hypoesthesia, oral paresthesia, and new or worsening findings of the cornea.

4. Number of Participants with Study Treatment Discontinuation due to AEs and SAEs up to Week 24

   Time frame: Up to Week 24

   An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

5. Number of Participants with AEs and SAEs Leading to Study Withdrawal up to Week 24

   Time frame: Up to Week 24

   An AE is any untoward medical occurrence in a clinical study participant administered a medicinal product and which does not necessarily have a causal relationship with that product. An SAE is defined as any untoward medical occurrence that, at any dose, meets one or more of the criteria listed: results in death, is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect in the offspring of a study participant; or other situations as per the medical or scientific judgment of the Investigator.

6. Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (millimeters of mercury [mm Hg]) at Week 24

   Time frame: Baseline, Week 24

7. Change from Baseline in Vital Sign: Pulse (beats per minute) at Week 24

   Time frame: Baseline, Week 24

8. Change from Baseline in Vital Sign: Respiratory Rate (breaths per minute) at Week 24

   Time frame: Baseline, Week 24

9. Change from Baseline in Vital Sign: Body Temperature (degrees Celsius) at Week 24

   Time frame: Baseline, Week 24

10. Change from Baseline in Vital Sign: Weight (kilograms [kg]) at Week 24

    Time frame: Baseline, Week 24

11. Change from Baseline in Male Reproductive Hormone: Total Testosterone (nanomoles per liter [nmol/L]) at Week 24

    Time frame: Baseline, Week 24

12. Change from Baseline in Male Reproductive Hormones: Follicle-Stimulating Hormone [FSH] and Luteinizing Hormone [LH] (international units per liter [IU/L]) at Week 24

    Time frame: Baseline, Week 24

13. Change from Baseline in Male Reproductive Hormone: Inhibin B (nanograms per liter [ng/L]) at Week 24

    Time frame: Baseline, Week 24

14. Change from Baseline in Hematology Parameter: Red Blood Cell (RBC) Count (10^12 cells per liter) at Week 24

    Time frame: Baseline, Week 24

15. Change from Baseline in Hematology Parameters: Hemoglobin and Mean Corpuscular Hemoglobin Concentration (MCHC) (grams per liter [g/L]) at Week 24

    Time frame: Baseline, Week 24

16. Change from Baseline in Hematology Parameter: Hematocrit (percentage) at Week 24

    Time frame: Baseline, Week 24

17. Change from Baseline in Hematology Parameter: Mean Corpuscular Volume (MCV) (femtoliters [fL]) at Week 24

    Time frame: Baseline, Week 24

18. Change from Baseline in Hematology Parameter: Mean Corpuscular Hemoglobin (MCH) (picograms per cell [pg/cell]) at Week 24

    Time frame: Baseline, Week 24

19. Change from Baseline in Hematology Parameter: Red Cell Distribution Width (RDW) (percentage) at Week 24

    Time frame: Baseline, Week 24

20. Change from Baseline in Hematology Parameters: White Blood Cell (WBC) Count (neutrophils, lymphocytes, monocytes, eosinophils, and basophils) and Platelet Count (10^9 cells per liter) at Week 24

    Time frame: Baseline, Week 24

21. Change from Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), and Gamma-Glutamyl Transferase (GGT) (units per liter [U/L]) at Week 24

    Time frame: Baseline, Week 24

22. Change from Baseline in Clinical Chemistry Parameters: Alkaline Phosphatase (ALP) and Creatine Kinase (CK) (international units per liter [IU/L]) at Week 24

    Time frame: Baseline, Week 24

23. Change from Baseline in Clinical Chemistry Parameters: Total Bilirubin, Direct and Indirect Bilirubin, and Creatinine (micromoles per liter) at Week 24

    Time frame: Baseline, Week 24

24. Change from Baseline in Clinical Chemistry Parameters: Sodium, Potassium, Chloride, Calcium, Magnesium, Bicarbonate, Glucose, and Blood Urea Nitrogen (BUN) (millimoles per liter [mmol/L]) at Week 24

    Time frame: Baseline, Week 24

25. Change from Baseline in Clinical Chemistry Parameters: Protein and Albumin (grams per liter [g/L]) at Week 24

    Time frame: Baseline, Week 24

26. Change from Baseline in Clinical Chemistry Parameter: Estimated Glomerular Filtration Rate (eGFR) (milliliters per minute per 1.73 meters squared [mL/min/1.73 m^2]) at Week 24

    Time frame: Baseline, Week 24

27. Change from Baseline in Clinical Chemistry Parameters: Prothrombin Time (PT) and Activated Partial Thromboplastin Time (aPTT) (seconds) at Week 24

    Time frame: Baseline, Week 24

28. Change from Baseline in Electrocardiogram (ECG) Value: Heart Rate (beats per minute) at Week 24

    Time frame: Baseline, Week 24

29. Change from Baseline in ECG Value: PR Interval, QT Interval, RR Interval, QRS Interval, and Corrected QT Interval Using Fridericia's Formula (QTcF) (milliseconds) at Week 24

    Time frame: Baseline, Week 24

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
• Individual participant dataSharing planned: Yes. Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk.com/en-gb/innovation/trials/data-transparency/

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• Active, not recruitingPhase 3

  A 24-Week Study of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

38 sites in 1 country: see every site and its status.