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

Phase 2

Terminated

Brief Summary: 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

Detailed 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Placebo oral tablet BID	Placebo	Randomized crossover design of matching placebo tablets to be administered orally BID
BLU-5937 oral tablet BID	BLU-5937	Randomized crossover design of 4 different doses (25, 50, 100, 200 mg BID) of BLU-5937 tablets to be administered orally BID

Primary Outcome Measures

Name	Time	Method
Change in Awake Objective Cough Frequency on Log-transformed Scale	Period 1: baseline (Day 0) and 24 hours after Day 4, 8, 12, 16 doses ; Period 2: baseline (Day 30) and 24 hours after Day 34, 38, 42, 46 doses	Change in awake cough frequency (average hourly cough frequency while the subject is awake ) evaluated using the VitaloJAK cough monitor with 24-hour sound recordings collected

Secondary Outcome Measures

Name	Time	Method

Locations (16): 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
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Allergy Associates Medical Group Inc.
🇺🇸San Diego, California, United States