A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough (NCT03979638) | Clinical Trial Compass
TerminatedPhase 2
A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough
Stopped: Trial was terminated due to the impact of the COVID-19 on trial activities. 68 patients with refractory chronic cough were enrolled with 52 completing treatment
United States, United Kingdom68 participantsStarted 2019-07-10
Plain-language 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
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 labora…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Awake Objective Cough Frequency on Log-transformed Scale
Timeframe: 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