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Early Phase 1 N=19 Randomized Double-blind Treatment

Cough Desensitization Therapy for Cough Hypersensitivity Syndrome

Cough

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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