Evaluation of the Efficacy and Safety of BLU-5937 in Adults With Refractory Chronic Cough (SOOTHE)

Bellus Health

Status and phase: Completed; Phase 2

Conditions: Refractory Chronic Cough

Treatments: Drug: Placebo; Drug: BLU-5937

Study type: Interventional

Funder types: Industry

Identifiers

NCT04678206

BUS-P2-02

2020-004136-17 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

The primary objective of this study is to determine the therapeutic dose of BLU-5937 in patients with refractory chronic cough by assessing the change from baseline to week 4 in the 24-hour cough frequency with BLU-5937 relative to placebo.

Enrollment: 310 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 (COPD), bronchiectasis, idiopathic pulmonary fibrosis or uncontrolled asthma
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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310 participants in 6 patient groups, including a placebo group

BLU-5937 Dose A

Experimental group

Description:

BLU-5937 oral dose A twice a day.

Treatment:

Drug: BLU-5937

BLU-5937 Dose B

Experimental group

Description:

BLU-5937 oral dose B twice a day.

Treatment:

Drug: BLU-5937

BLU-5937 Dose C

Experimental group

Description:

BLU-5937 oral dose C twice a day.

Treatment:

Drug: BLU-5937

Placebo

Placebo Comparator group

Description:

Matching Placebo for BLU-5937 oral dose twice a day.

Treatment:

Drug: Placebo

BLU-5937 Dose A (Population with baseline cough < 25 coughs/hour)

Experimental group

Description:

BLU-5937 oral dose A twice a day.

Treatment:

Drug: BLU-5937

Placebo (Population with baseline cough < 25 coughs/hour)

Placebo Comparator group

Description:

Matching Placebo for BLU-5937 oral dose twice a day.

Treatment:

Drug: Placebo