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

Bellus Health

Status and phase

Terminated

Phase 2

Conditions

Chronic Refractory Cough

Treatments

Drug: Placebo

Drug: BLU-5937

Study type

Interventional

Funder types

Industry

Identifiers

NCT03979638

BUS-P2-01

2019-000375-16 (EudraCT Number)

Details and patient eligibility

About

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

Full description

This study will have two 16-day treatment periods (four escalating doses or matching placebo at four days interval) separated by a 10 to 14-day washout period. There will be a 14-day follow-up period.

Enrollment

68 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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