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

A Randomized, Double-Blind, Placebo-Controlled, Crossover, Dose Escalation Study of BLU-5937 in Subjects With Unexplained or Refractory Chronic Cough (RELIEF)

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

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.

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