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NCT04256733 · ClinicalTrials.gov registry record · Early Phase 1
Cough Desensitization Therapy for Cough Hypersensitivity Syndrome
A Early Phase 1 study of Cough, sponsored by University of Montana.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT04256733: Completed Early Phase 1 study of Cough, sponsored by University of Montana.
NCT04256733 is a Early Phase 1 study of Cough that has completed, run by University of Montana. The registered enrollment target is 19 participants, below the 220-participant average among 12 other Cough trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04256733, a Early Phase 1 study of Cough, has completed, sponsored by University of Montana.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The Leicester Cough Questionnaire (LCQ) is a 19-item validated patient-report questionnaire that measures the impact of cough on quality of life. It takes about 5 minutes to complete and results in three domain scores (Social, Psychological, and Physical), and one Total score. Domain scores are averages of the questions that make up each domain. Minimum and maximum domain scores are 1 and 7, respectively. The domain scores are summed to determine the Total score, which can range from 3 to 21. A
Conditions Studied
Interventions
- BIOLOGICAL 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
Study Locations (1)
Montana
- University of Montana - Missoula
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2019-05-01 |
| Est. Completion | 2021-02-13 |
| Phase | Early Phase 1 |
What the finished NCT04256733 record still lists
NCT04256733 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 220-participant average among 12 other Cough trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Cough appearing as the primary indexed condition, and to 2 interventions - of which Supra-threshold and progressive doses of diluted capsaicin via a Koko Digidoser nebulizer is the first listed.
NCT04256733 reports a single indexed study location in Montana.
Frequently Asked Questions
What is clinical trial NCT04256733 about?
NCT04256733 is a clinical study titled "Cough Desensitization Therapy for Cough Hypersensitivity Syndrome". 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 epit...
What is the current status of trial NCT04256733?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 19 participants. The study started on 2019-05-01. Estimated completion is 2021-02-13.
What conditions does trial NCT04256733 study?
This clinical trial studies the following conditions: Cough.
What interventions are being tested in trial NCT04256733?
The interventions under investigation include: 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).
Who is sponsoring clinical trial NCT04256733?
This trial is sponsored by University of Montana, which has 24 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04256733 being conducted?
This trial has 1 study location across Montana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04256733's enrollment target sits among peer trials
19 12th of 12 higher than 1 of 12 other Cough trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cough trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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