N/A
N=39
Internet-Behavioral Cough Suppression Therapy
Cough · Chronic Disease
Bottom Line
View on ClinicalTrials.gov: NCT05770401 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Leicester Cough Questionnaire — 9.04; 8.86; 12.78; 9.44 Total LCQ Score — p=.014
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Internet-Behavioral Cough Suppression Therapy (Behavioral); Sham Treatment (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Montana
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Leicester Cough Questionnaire |
9.04; 8.86; 12.78; 9.44; 13.04; 9.70 | .014 sig |
| SECONDARY Cough Severity Visual Analog Scale |
49; 49.08; 33.94; 50.08; 44.18; 56.42 | .056 |
Summary
The goal of this randomized, placebo-controlled, clinical trial is to develop and test the efficacy of an Internet-based behavioral intervention for refractory chronic cough. The main questions it aims to answer are:
* What are the best recruitment pathways to find people living with refractory chronic cough in Montana?
* Is Internet-Behavioral Cough Suppression Therapy (iBCST) efficacious?
* Do iBCST participants find it satisfactory?
* Is using Hyfe research app to monitor cough frequency feasible in rural areas?
Participants will complete iBCST or a placebo treatment virtually. Some participants will take part in qualitative interviews and use Hyfe research app for ambulatory cough frequency monitoring.
Eligibility Criteria
Inclusion Criteria
- No barriers to using a computer or smartphone (e.g., no significant fine motor or visual problems).
- Internet and e-mail access and the ability to use it.
- Suffering from a cough lasting at least eight weeks that is:
- Largely unproductive (cough up no more than a few teaspoons worth of clear or white sputum or mucus in a 24-hour period).
- Report of cough triggered by identifiable stimuli including and not limited to any combination of the following: cold air, talking, laughing, taking a deep breath, exercise, crumbly foods, strong smells or odors, fumes from paint or cleaning sprays.
- Often preceded by the sensation of an urge-to-cough (e.g., tickle or itch) at the level of the throat.
- Self-report of receiving the following assessments for current cough symptoms with unremarkable results:
- Physical evaluation by at least one physician.
- Chest x-ray.
- Willingness to avoid other potential cough treatments during the course of the study (or alert study personnel if alternative treatment is implemented out of necessity).
Exclusion Criteria
- Current smoker of any substance.
- Diagnosis of any of the following:
- Respiratory disease (e.g., chronic obstructive pulmonary disease, asthma)
- Neurogenic disease (e.g., Parkinson's disease, cerebrovascular disease)
- Head and neck cancer
- Self-report of difficulty swallowing since having chronic cough
- Use of the following medication:
- Angiotensin-converting enzyme inhibitor (ACE-I) in the past four weeks: benzapril (Lotensin), Captopril (Capoten), Enalapril/Enalaprilat (Vasotec oral and injectable), Fosinopril (Monopril), Lisinopril (Zestril and Prinivil), Moexipril (Univasc), Perindopril (Aceon), Quinapril (Accupril), Ramipril (Altace), and Trandolapril (Mavik).
- Use of a neuromodulator medication in the past 48 hours: Neurontin (Gabapentin) and amitriptyline.
- Individuals with dysphonia (abnormal voice; either self-reported or perceived by study personnel during enrollment interview) will be excluded unless they have had a normal laryngoscopy (endoscopic assessment of the larynx) by an otolaryngologist (ENT) within the past year specifically for their cough.
Data sourced from ClinicalTrials.gov (NCT05770401). 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.