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

Conditions

• Chronic Cough (CC)
• Refractory Chronic Cough
• Unexplained Chronic Cough

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• BCS+inactive — BEHAVIORAL
  Behavioral cough suppression therapy plus inactive inhaled drug. Treatment given twice per week for 12 sessions.
• BCS+active — COMBINATION_PRODUCT
  Behavioral cough suppression therapy combined with inhaled natural substance known to desensitize sensory nerves. Treatment given twice per week for 12 sessions.

Study Details

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.

Key Dates

Start date

Jun 29, 2026

Status verified

Jun 2026

Primary completion

Jun 30, 2029

Completion

Mar 31, 2030

Study Design

Enrollment

135 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Behavioral treatment plus inactive drug
  Participants receive behavioral cough suppression therapy (BCST) combined with an inactive inhaled substance.
• Experimental: Behavioral treatment plus inhaled drug
  Participants receive behavioral cough suppression (BCS) therapy combined with inhaled drug designed to enhance BCS therapy
• No Intervention: fMRI Control
  Participants will undergo assessments without treatment

Primary Outcome Measure

Cough threshold sensory testing (CTT) [ Time Frame: From enrollment to 4 weeks following enrollment ]

Central Contacts

• Laurie J Slovarp, PhD
  406-243-2107
  [email protected]
• Marie Jetté, PhD
  [email protected]

Locations (3)

Find similar trials in Aurora, CO

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