Refractory Chronic CoughEarly Phase 1NCT06706765
Group Telehealth Behavioral Cough Suppression Therapy
A Early Phase 1 study testing Behavioral Treatment in people with Refractory Chronic Cough, run by University of Montana at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effectiveness of behavioral cough suppression therapy (BCST) in managing refractory chronic cough (RCC) within a group telehealth setting. RCC is a cough that has lasted at least 8 weeks and has not resolved with standard medical treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Chronic Cough
- What is being tested?
- Behavioral Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2024to 31 Jan 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Predominantly dry cough for at least 8 weeks
- Evaluated and treated by at least one physician for cough
- Obtained a chest X-ray or chest CT scan specifically related to the cough with unremarkable results
- Access to a computer or tablet that includes a camera and able to use the device independently
- Reliable internet access
- Willing to agree to maintain confidentiality of personal information (including names) related to others in the study
Who cannot join
- Under age 18
- Coughing up blood
- Current smoker of any substance
- History of smoking or 10 or more years
- Diagnosed with a chronic lung condition (e.g., COPD, emphysema, lung cancer, idiopathic pulmonary fibrosis, chronic bronchitis, asthma)? (NOTE: If a patient has been told their cough may be (or is likely) due to asthma but they have not had any formal lung testing and asthma treatments have not helped your cough, we don't consider this a formal asthma diagnosis and will not exclude them from the study.)
- Diagnosed currently or in the past with head and neck cancer (i.e., cancer of the mouth, nose, or throat).
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- Complaints of swallowing difficulty
- Taking any of the following medications, which have a known side effect of cough: 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)
- Prior BCST treatment with an SLP or respiratory therapist
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Montana
Missoula, Montana, 59812
Jane E Reynolds, PhD, 406-243-2138, jane.reynolds@mso.umt.edu
Laurie J Slovarp, PhD, 406-243-2107, laurie.slovarp@mso.umt.edu
About this study
Official title: Group Telehealth Behavioral Cough Suppression Therapy Pilot Study
The purpose of this study is to investigate the effectiveness of behavioral cough suppression therapy (BCST) in managing refractory chronic cough (RCC) within a group telehealth setting. RCC is a cough that has lasted at least 8 weeks and has not resolved with standard medical treatment. BCST is a research-based treatment provided by specialty-trained speech-language pathologists (SLPs) for patients with RCC. Although the treatment works very well for a large proportion of patients in a standard one-on-one format, there are a limited number of SLPs available to provide this treatment and patients living in rural areas do not typically have access to an SLP trained in BCST. If BCST can effectively be delivered in a group telehealth model, it would significantly improve accessibility to the treatment.
- Conditions
- Refractory Chronic Cough
- Being tested
- Behavioral Treatment
- Medical subject headings
- Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral TreatmentBehavioural
Behavioral cough suppression therapy delivered in a group setting via telehealth.
| Study group | Role | What they receive |
|---|---|---|
| Group Telehealth Behavioral Cough Suppression Therapy | Experimental | Not described Receives: Behavioral: Behavioral Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leicester Cough Questionnaire
The Leicester Cough Questionnaire is a 19-item self-report questionnaire that is valid and reliable, and repeatable every two weeks. The total possible score is 21. The higher the score the better the cough-related quality of life.
Measured: Baseline, one-week post-treatment, and one-month post-treatment
Secondary outcomes (1)
Patient Global Impression of Severity Scale in Chronic Cough
The Patient Global Impression of Severity Scale in Chronic Cough involves the patient answering the question "how do you rate your overall current cough severity?" with options of "no problem, mild, moderate, or severe problem."
Measured: Baseline, every treatment session (4-6 treatment sessions, one treatment session per week), and one-month post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start22 Mar 2024
- Primary completion31 Jan 2025 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Chronic CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Montana
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06706765
- Sponsor's protocol ID
- IRB-FY2024-36
- Status last verified
- Aug 2024
- First submitted
- 29 Aug 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Telehealth Behavioral Cough Suppression Therapy Pilot Study
- ClinicalTrials.gov ID
- NCT06706765
- Acronym / sponsor ID
- IRB-FY2024-36
- Conditions
- Refractory Chronic Cough
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of MontanaUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 27 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the effectiveness of behavioral cough suppression therapy (BCST) in managing refractory chronic cough (RCC) within a group telehealth setting. RCC is a cough that has lasted at least 8 weeks and has not resolved with standard medical treatment. BCST is a research-based treatment provided by specialty-trained speech-language pathologists (SLPs) for patients with RCC. Although the treatment works very well for a large proportion of patients in a standard one-on-one format, there are a limited number of SLPs available to provide this treatment and patients living in rural areas do not typically have access to an SLP trained in BCST. If BCST can effectively be delivered in a group telehealth model, it would significantly improve accessibility to the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group Telehealth Behavioral Cough Suppression Therapy | Experimental | Behavioral: Behavioral Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- At least 18 years old
- Predominantly dry cough for at least 8 weeks
- Evaluated and treated by at least one physician for cough
- Obtained a chest X-ray or chest CT scan specifically related to the cough with unremarkable results
- Access to a computer or tablet that includes a camera and able to use the device independently
Key exclusion criteria (9 listed)
- Under age 18
- Coughing up blood
- Current smoker of any substance
- History of smoking or 10 or more years
- Diagnosed with a chronic lung condition (e.g., COPD, emphysema, lung cancer, idiopathic pulmonary fibrosis, chronic bronchitis, asthma)? (NOTE: If a patient has been told their cough may be (or is likely) due to asthma but they have not had any formal lung testing and asthma treatments have not helped your cough, we don't consider this a formal asthma diagnosis and will not exclude them from the study.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral TreatmentBehavioral cough suppression therapy delivered in a group setting via telehealth. | Behavioural | Group Telehealth Behavioral Cough Suppression Therapy |
Primary outcome
Leicester Cough Questionnaire
Time frame: Baseline, one-week post-treatment, and one-month post-treatment
The Leicester Cough Questionnaire is a 19-item self-report questionnaire that is valid and reliable, and repeatable every two weeks. The total possible score is 21. The higher the score the better the cough-related quality of life.
1 secondary outcome
Patient Global Impression of Severity Scale in Chronic Cough
Time frame: Baseline, every treatment session (4-6 treatment sessions, one treatment session per week), and one-month post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Behavioral Treatment in people with Refractory Chronic Cough, run by University of Montana at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jane E Reynolds, PhD (406-243-2138, jane.reynolds@mso.umt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leicester Cough Questionnaire (time frame: Baseline, one-week post-treatment, and one-month post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.