Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06960759 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Mechanisms of Change in Behavioral Cough Suppression Therapy for Refractory Chronic Cough

Study acronym: CoughLESS
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor Start date changed from estimate of Aug 15, 2026 to Aug 13, 2026v7
  2. Notable Recruitment opened
    • Start date: Jul 29, 2026 to Aug 15, 2026
    • Site details revised at 3 of 3 sites
    v6
  3. Notable Start date: Jun 29, 2026 to Jul 29, 2026v5
  4. Notable Start date: May 15, 2026 to Jun 29, 2026
    • Interventions: Behavioral cough suppression therapy combined with capsaicin inhalation (BCS+CAP) (Combination Product), Behavioral cough suppression… to BCS+active (Combination Product), BCS+inactive (Behavioral)
    • Study description expanded, about 25 words
    v4
  5. Notable Start date: Aug 1, 2025 to May 15, 2026v3 Show 6 more changesShow less
    • Primary endpoints revised (4)
    • Enrollment target: 150 to 135
    • Interventions: Behavioral cough suppression therapy combined with capsaicin inhalation (BCS+CAP) (Combination Product), Behavioral cough suppression… to Behavioral cough suppression therapy combined with capsaicin inhalation (BCS+CAP) (Combination Product), Behavioral cough suppression…
    • Eligibility criteria expanded, about 432 words
    • Secondary endpoints: 2 to 10
    • Study description expanded, about 211 words
  6. Minor Study description expanded, about 2 wordsv2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is testing new ways to help people who have chronic cough that has not improved with typical treatments. One approach is called behavioral cough suppression (BCS) therapy, which teaches people techniques to stop themselves from coughing. Another approach uses a natural substance thought to help reduce the body's sensitivity to cough triggers. In this study, we will test two treatments and include one no-treatment control group. The control group will undergo baseline testing, cough monitoring, and an fMRI brain scan and will be offered BCS at end of study participation. The two treatments include: * BCS therapy with active inhaled treatment (BCS+active), * BCS therapy with inactive inhaled treatment (BCS+inactive), The investigators will enroll 135 adults with refractory chronic cough (RCC). 100 participants who qualify and are willing and able to complete 14 study visits in the clinic and two online study visits will be randomly assigned to one of the two treatments. The no-treatment control group (n=35) will be recruited from adults with RCC who are willing to complete baseline testing and fMRI but are not able or willing to attend 14 study clinic visits. These participants will not be randomized. The investigators want to find out how these treatments affect: * How sensitive someone is to things that make them cough, * How well they can hold back a cough when they try, * How their brain responds to things that cause an urge-to-cough, * And how much their coughing affects their quality of life. The investigators believe both treatments will reduce sensitivity to cough stimulants, reduce cough severity, and improve quality of life, but BCS+active inhaled treatment will work better than BCS+inactive inhaled treatment.
Trial Details
NCT Number NCT06960759
Lead Sponsor University of Montana
Collaborators: University of Colorado, Denver, Emory University, University of Melbourne
Conditions
(from sponsor)
Chronic Cough (CC), Refractory Chronic Cough, Unexplained Chronic Cough
Related terms Chronic Cough, cough hypersensitivity syndrome
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov