Early Phase 1
N=19
Cough Desensitization Therapy for Cough Hypersensitivity Syndrome
Cough
Bottom Line
View on ClinicalTrials.gov: NCT04256733 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Leicester Cough Questionnaire (LCQ) — 3.2; 2.06 score on a scale — p=.23
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Supra-threshold and progressive doses of diluted capsaicin via a Koko Digidoser nebulizer (Biological); Sub-threshold doses of diluted capsiacin via a KoKo Digidoser nebulizer (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Montana
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Leicester Cough Questionnaire (LCQ) |
3.2; 2.06 | .23 |
| SECONDARY Urge-to-Cough Testing |
-13.75; -8.8 | .57 |
| SECONDARY Urge-to-Cough Testing: Cough Frequency |
-14.00; -6.33 | <.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age
- Currently suffering from a cough that started at least 8 weeks ago
- Have seen at least one physician for the cough and have received medical treatment without success
- Normal chest x-ray, pulmonary function testing, and laryngoscopy (laryngoscopy completed by your physician or the speech-language pathologist)
- Have undergone behavioral cough suppression therapy without full resolution of cough
- Willing to take a pregnancy test before enrollment (if applicable)
- Willing to use contraception during the study (if applicable)
- Willing to sign an informed consent form
Exclusion Criteria
- Under 18 years of age
- Currently a smoker of any substance
- Pregnant or attempting to become pregnant
- Diagnosed with a respiratory or pulmonary condition (e.g., asthma, COPD, emphysema, lung cancer, bronchitis)
- Taken any of the following medications within the past month: lisinopril/Prinivil/Zestril, captopril/Capoten, enalapril/Epaned/Asotec, ramipril/Altace, benazepril/Lotensin, fosinopril/Monopril, moexipril/Univasc, perindopril/Aceonm, quinapril/Accupril, trandolapril/Mavik
Data sourced from ClinicalTrials.gov (NCT04256733). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.