Behavioral Cough Suppression Therapy for Chronic Cough

Recruiting at 2 trial locations

Overseen By Marie Jetté, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Montana

Must not be taking: ACE-inhibitors

Disqualifiers: Smoking, Upper respiratory infection, Hemoptysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have used an ACE-inhibitor in the past 60 days, you cannot participate.

What data supports the effectiveness of the treatment Behavioral Cough Suppression Therapy for chronic cough?

Research shows that Behavioral Cough Suppression Therapy (BCST) is effective for chronic cough, with studies indicating up to 88% effectiveness in treating refractory chronic cough. Additionally, 87% of patients reported significant improvement in their cough symptoms after BCST, suggesting it can be a beneficial treatment option. ^{1 2 3 4 5}

Is Behavioral Cough Suppression Therapy safe for humans?

Behavioral Cough Suppression Therapy (BCST) is generally considered safe as it involves non-drug techniques to help manage chronic cough, and there are no reports of harmful effects in the studies reviewed. ^{1 3 6 7 8}

How is Behavioral Cough Suppression Therapy different from other treatments for chronic cough?

Behavioral Cough Suppression Therapy is unique because it is a non-drug treatment that focuses on teaching patients techniques to control their cough through education, breathing exercises, and counseling. Unlike medications, it aims to reduce cough reflex sensitivity and improve cough-related quality of life without the use of drugs. ^{1 2 5 9 10}

What is the purpose of this trial?

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 capsaicin, the substance that makes chili peppers hot, to help reduce the body's sensitivity to cough triggers. In this study, we will test three treatments: * BCS therapy with capsaicin (BCS+CAP), * BCS therapy with a placebo (BCS+Sham), * Capsaicin stimulation alone (CAP). The investigators will enroll 150 adults with chronic cough and randomly assign them to one of the three treatments. Each person will attend 12 treatment sessions. 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 all treatments may reduce sensitivity to cough stimulants, but BCS treatments will also improve how people sense and control the urge to cough. The investigators think combining BCS with capsaicin will work the best overall.

Research Team

Laurie J Slovarp, PhD

Principal Investigator

University of Montana

Marie Jetté, PhD

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

This trial is for adults with chronic cough that hasn't improved with standard treatments. Participants will be taught techniques to suppress coughing and may inhale capsaicin or a placebo. They must attend 12 sessions.

Inclusion Criteria

Willing to use contraception during the study (if applicable)

Proficient reader/speaker of English

Willing to take a pregnancy test before enrollment (if applicable)

Exclusion Criteria

Currently a smoker of any substance

Live with or work with anyone with chronic cough

Pregnant or trying to become pregnant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three treatments: BCS therapy with capsaicin, BCS therapy with placebo, or capsaicin stimulation alone, over 12 sessions

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cough sensitivity and suppression ability

9 weeks

Treatment Details

Interventions

• Behavioral Cough Suppression Therapy
• Capsaicin

Trial Overview The study tests three methods: behavioral cough suppression therapy (BCS) combined with either capsaicin (BCS+CAP) or a sham treatment (BCS+Sham), and capsaicin inhalation alone (CAP). It aims to see how these affect cough sensitivity, control, brain response, and quality of life.

Participant Groups

Group I: Inhaled drug Experimental Treatment 1 Intervention

Participants inhale a drug designed to desensitize the cough reflex.

Group II: Behavioral treatment plus inhaled drug Experimental Treatment 1 Intervention

Participants receive behavioral cough suppression therapy (BCST) combined with inhaled vaporized drug designed to enhance BCST

Group III: Behavioral treatment plus inactive drug Active Control 1 Intervention

Participants receive behavioral cough suppression therapy (BCST) combined with an inactive inhaled substance.

Who Is Running the Clinical Trial?

University of Montana

Lead Sponsor

Trials

29

Recruited

4,700+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

University of Melbourne

Collaborator

Trials

193

Recruited

1,287,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Factors influencing behavioral cough suppression therapy in children with nonspecific chronic cough. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Treatment of Chronic Cough. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Integration of Behavioral Cough Suppression Therapy Into Lung Cancer Care: Nonpharmacologic Interventions for Chronic Cough. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Assessing referral and practice patterns of patients with chronic cough referred for behavioral cough suppression therapy. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Behavioral Cough Suppression Therapy Delivered via Telehealth. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Recommendations for the proper use of nonprescription cough suppressants and expectorants in solid-organ transplant recipients. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Currently available antitussives. [2009]

8. India pubmed.ncbi.nlm.nih.gov

Decreasing Target Behavior in a Child Using Functional Behavior Assessment and Differential Reinforcement. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Cough suppression therapy: does it work? [2022]

10. England pubmed.ncbi.nlm.nih.gov

Review series: chronic cough: behaviour modification therapies for chronic cough. [2022]