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Experimental: Supra-threshold capsaicin for Cough (CDTPilot2 Trial)

Phase 1
Waitlist Available
Led By Laurie Slovarp, PhD
Research Sponsored by University of Montana
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the lcq will be measured before treatment (baseline) and 1 week post treatment
Awards & highlights

CDTPilot2 Trial Summary

The purpose of this study is to investigate a modified behavioral treatment for chronic cough due to cough hypersensitivity syndrome (CHS). This type of CC is a non-productive cough that is due, in part, to over-expression of transient receptor potential vanilliod (TRPV) receptors in the airway epithelium, which contribute to a dry cough elicited by typically non-tussive stimuli (e.g., cold air, smells) or by low doses of tussive stimuli (e.g., smoke). Currently available treatment options are limited to neuromodulator medications (e.g., gabapentin, amytriptiline) and behavioral cough suppression therapy (BCST), neither of which is 100% effective. The primary component of BCST is teaching patients to suppress their cough in the presence of an urge-to-cough. Studies have confirmed a reduction in cough sensitivity (as tested with inhaled capsaicin) following 1-4 weeks of successful cough suppression. However, patients with severe CHS are not able to suppress their cough in the presence of uncontrollable environmental stimuli and, hence, do not respond well to the therapy. The purpose of this study is to determine the potential of treating CHS by implementing BCST while stimulating cough with progressive concentrations of inhaled diluted aerosolized capsaicin. The investigators hypothesize this treatment will result in a reduction in cough-reflex sensitivity, cough-related quality of life, and cough frequency.

CDTPilot2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the lcq will be measured before treatment (baseline) and 1 week post treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and the lcq will be measured before treatment (baseline) and 1 week post treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline Leicester Cough Questionnaire (LCQ) score at 1 week post-treatment
Change from baseline visual analogue cough severity score at 1 week post-treatment
Secondary outcome measures
Change from baseline cough-reflex sensitivity at 1 week post-treatment
Coughing

Side effects data

From 2016 Phase 4 trial • 120 Patients • NCT03124407
65%
Application site pain
18%
Application site pruritus
3%
Application site erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
QD-Active
QD-Vehicle
BID-Active
BID-Vehicle

CDTPilot2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: Supra-threshold capsaicinExperimental Treatment1 Intervention
Arm: Experimental: Supra-threshold capsaicin Participants will be exposed to progressively increasing concentrations of aerosolized capsaicin (the ingredient in chili peppers that makes them spicy, and a known cough stimulant) to stimulate an urge-to-cough. Participants will be coached to implement cough suppression strategies following each exposure.
Group II: Arm: Placebo Comparator: SalinePlacebo Group1 Intervention
Participants will be exposed repeatedly to aerosolized saline through a nebulizer during treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Supra-threshold and progressive doses of diluted capsaicin via a dosimeter-controlled nebulizer
2021
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

University of MontanaLead Sponsor
23 Previous Clinical Trials
3,532 Total Patients Enrolled
2 Trials studying Cough
67 Patients Enrolled for Cough
Laurie Slovarp, PhDPrincipal InvestigatorUniversity of Montana

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~6 spots leftby Apr 2025