Behavioral Cough Suppression Therapy for Chronic Cough

Not yet recruiting at 2 trial locations
LJ
MJ
Overseen ByMarie Jetté, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to assist individuals with chronic cough unresponsive to standard treatments. It tests three approaches: Behavioral Cough Suppression Therapy, a hot pepper extract called capsaicin that may reduce cough sensitivity, and a combination of both. Participants will attend 12 sessions to evaluate the treatments' effects on cough sensitivity, cough control, brain response to cough triggers, and overall quality of life. The trial seeks adults with a long-term cough not explained by other health issues and unchanged despite normal lung tests in the past two years. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both behavioral cough suppression therapy (BCST) and capsaicin inhalation are generally safe for people with chronic cough. Studies have found that BCST can improve cough symptoms in up to 87% of patients. This therapy typically requires no more than four sessions and is considered effective and affordable.

For capsaicin inhalation, research suggests it is safe and well tolerated. Capsaicin, the ingredient that makes chili peppers spicy, has been used in various forms to reduce cough sensitivity. One study found that inhaling capsaicin is safe and tolerable, even for people with sensitive airways.

While both treatments are generally well tolerated, individual experiences may vary. Consulting a healthcare provider before joining a clinical trial is always advisable.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Behavioral Cough Suppression Therapy (BCST) because it offers a non-drug approach to managing chronic cough, differing from typical treatments like cough syrups and medications that primarily aim to suppress symptoms. This method focuses on training individuals to consciously control their cough reflex through specific behavioral techniques. Additionally, when combined with an inhaled vaporized drug, it potentially enhances the therapy's effectiveness by working to desensitize the cough reflex itself. This approach not only targets symptom relief but also addresses the underlying mechanism, potentially providing a more sustainable solution for chronic cough sufferers.

What evidence suggests that this trial's treatments could be effective for chronic cough?

Studies have shown that behavioral cough suppression therapy (BCS) is effective for individuals with chronic cough. Many patients experience a significant reduction in cough frequency, with some studies indicating success up to 88% of the time. Research indicates that BCS helps patients better control their urge to cough and enhances their quality of life.

In this trial, participants will receive different treatments. One group will receive behavioral cough suppression therapy combined with an inactive inhaled substance. Another group will receive behavioral cough suppression therapy combined with an inhaled vaporized drug designed to enhance BCS. Capsaicin, the active ingredient in chili peppers, has been studied for its effects on chronic cough and is known to reduce the sensitivity of the cough reflex, leading to fewer and milder coughing episodes. In this trial, one group will inhale a drug designed to desensitize the cough reflex, potentially including capsaicin. Combining BCS with such a drug may yield the best results by both improving cough control and reducing sensitivity to cough triggers.12678

Who Is on the Research Team?

LJ

Laurie J Slovarp, PhD

Principal Investigator

University of Montana

MJ

Marie Jetté, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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)
See 6 more

Exclusion Criteria

Currently a smoker of any substance
Live with or work with anyone with chronic cough
Pregnant or trying to become pregnant
See 7 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Inhaled drugExperimental Treatment1 Intervention
Group II: Behavioral treatment plus inhaled drugExperimental Treatment1 Intervention
Group III: Behavioral treatment plus inactive drugActive Control1 Intervention

Find a Clinic Near You

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+

Citations

Efficacy of behavioral cough suppression therapy for refractory ...Results showed a statistically significant reduction in cough frequency among patients with chronic cough compared to those receiving simple ...
Effect of Behavioral Cough Suppression Therapy Delivered ...Behavioral cough suppression therapy (BCST) has demonstrated up to 88% effectiveness at treating refractory chronic cough (RCC). With onset of the COVID-19 ...
Telehealth Group Behavioral Cough Suppression Therapy for ...Mean LCQ improvement was 7.04 at both one-week and one-month post-treatment assessments (both p<.001, d=2.54 and 2.35, respectively). PGI-S ...
Internet-Based Behavioral Cough Suppression Therapy for ...Purpose:The purpose of this study was to assess the efficacy of internet-based behavioral cough suppression therapy (IBCST) and explore users' experiences.
Evaluation and Management Outcomes and Burdens in ...BCST is safe, improves cough outcomes in up to 87% of patients, is inexpensive and efficient (i.e., patients typically need no more than four treatment sessions) ...
A randomized, sham-controlled pilot trial for patients with ...The purpose of this study was to determine feasibility of treating refractory chronic cough (RCC) with progressive doses of capsaicin paired with cough ...
Group Telehealth Behavioral Cough Suppression TherapyThe purpose of this study is to investigate the effectiveness of behavioral cough suppression therapy (BCST) in managing refractory chronic cough (RCC) within a ...
Evaluation and Management Outcomes and Burdens in ...BCST is safe, improves cough outcomes in up to 87% of patients, is inexpensive and efficient (i.e., patients typically need no more than four ...
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