A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Chronic Refractory Cough

In brief

This is a multi-center, randomized, double-blind, placebo-controlled, crossover, dose escalation study of BLU-5937 in subjects with unexplained or refractory chronic cough

Key facts

Study ID

NCT03979638

Run by

Bellus Health Inc. - a GSK company

People needed

68

Starts

2019-07-10

Expected to finish

2020-04-23

Last updated by the study team

2021-08-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Unexplained or refractory chronic cough for at least one year
• Chest radiograph or CT thorax within the last 60 months not demonstrating any abnormality considered to be significantly contributing to the chronic cough
• Cough count of ≥ 10 per hour (Awake Cough Count) at Screening
• Score of ≥ 40mm on the Cough Severity VAS at Screening
• Women of child-bearing potential must have a negative serum pregnancy test at Screening
• Women of child-bearing potential must use a highly effective contraception method from Screening through the Follow-Up Visit
• Male subjects and their partners of child-bearing potential must use 2 methods of acceptable birth control

You may not qualify if…

• Current smoker or individuals who have given up smoking within the past 6 months, or those with >20 pack-year smoking history
• Diagnosis of COPD, bronchiectasis, idiopathic pulmonary fibrosis
• Treatment with an ACE-inhibitor as the potential cause of a subject's cough, or requiring treatment with an ACE-inhibitor during the study, or within 12 weeks prior to the Screening Visit
• FEV1/FVC < 60%
• History of upper respiratory tract infection or recent significant change in pulmonary status within 4 weeks of the Baseline Visit
• History of concurrent malignancy or recurrence of malignancy within 2 years prior to Screening
• History of a diagnosis of drug or alcohol dependency or abuse within the last 3 years
• Clinically significant abnormal electrocardiogram (ECG) or laboratory tests at Screening
• Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results

Where it is running

• Allergy Associates Medical Group Inc. — San Diego, California, United States
• Allergy & Asthma Associates of Santa Clara Valley — San Jose, California, United States
• Centre for Cough — Largo, Florida, United States
• Clinical Research Institute — Minneapolis, Minnesota, United States
• Clinical Research of Gastonia — Gastonia, North Carolina, United States
• National Allergy & Asthma Research — Charleston, South Carolina, United States
• Diagnostics Research Group — San Antonio, Texas, United States
• Allergy Asthma & Sinus Center — Greenfield, Wisconsin, United States
• Belfast City Hospital — Belfast, United Kingdom
• Castle Hill Hospital — Cottingham, United Kingdom
• University Hospitals of Leicester — Leicester, United Kingdom
• Prince Phillip Hospital — Llanelli, United Kingdom
• King's College Hospital — London, United Kingdom
• Royal Brompton Hospital — London, United Kingdom
• Manchester Clinical Research Facility — Manchester, United Kingdom
• North Tyneside General Hospital — North Shields, United Kingdom

Full record on ClinicalTrials.gov

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