Clinical trial NCT04767074: A Non-pharmacological Cough Control Therapy
Official title: A Non-pharmacological Cough Control Therapy as an Adjuvant of Pulmonary Rehabilitation in People With Interstitial Lung Diseases and Chronic Cough - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cough
ILD
Pulmonary Disease
Pulmonary Fibrosis
Keywords: Cough
ILD
Pulmonary rehabilitation
chronic cough
non-pharmacological cough therapy
Lead sponsor: West Park Healthcare Centre
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
First posted: 2021-02-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility Pre/Post interventional study
Primary purpose: TREATMENT

Brief summary: Coughing affects almost all individuals with ILD leading to physical, psychological and social distress and prevents individuals from performing their activities of daily living, working or socialising in public places. Unfortunately, there are no licensed medications available to treat chronic cough and the few drugs that have been tried resulted in little efficacy and significant side effects. Drug-free cough control interventions have shown promise in reducing the severity and impact of coughing on patients' lives but have not been tested in individuals with ILD. This study aims to explore the feasibility and effectiveness of a non-pharmacological cough control therapy, as an adjuvant of pulmonary rehabilitation, in patients with ILD and chronic cough (\>8 weeks in duration).

Detailed description: Research questions and hypotheses

i) Is a non-pharmacological cough control therapy feasible to treat chronic cough in patients with ILD? Hypothesis: Given the results of previous non-pharmacological interventions in patients with refractory cough, we predict that this intervention will be feasible and well accepted in patients with ILD.

ii) Is a non-pharmacological cough control therapy more effective than pulmonary rehabilitation (PR) alone to treat chronic cough in patients with ILD? Hypotheses: Given the results of previous non-pharmacological interventions in patients with refractory cough, we predict that improvements observed in participants receiving the non-pharmacological intervention will exceed those receiving PR alone. Improvements are expected in HRQOL (exceeding the minimal clinically important difference), intensity of cough-related sensations and symptoms of fatigue.

Research Design The proposed research is a feasibility pre-post intervention study.

Study details:

Adults with ILD and chronic cough will be enrolled in this study. Potential eligible patients will be recruited from the outpatient PR program at West Park Healthcare Centre and St. Joseph's Healthcare. As the outpatient pulmonary rehabilitation program at West Park Healthcare Center and St. Joseph's Healthcare will transition partially to virtual meetings, the interactions between the research team and patients will be completed via phone calls or online.

This research study will be delivered online using the Zoom Healthcare Plan, an online platform that is available at West Park Healthcare Centre, and is used for telerehabilitation programs. Participants will be enrolled into a PR program composed of aerobic and strengthening exercises, disease-specific education and self-management, as part of their usual care. Two weeks before termination of PR, participants will start the non-pharmacological cough control therapy, following the intervention proposed by Chamberlain colleagues (2017). Participants will attend four virtual sessions of 45 to 60 minutes of educational and self-management

This study will measure several clinical outcomes.

1. Feasibility will be reflected by the number of eligible patients enrolling (enrolment rate of at least 75%) and completing the intervention (attendance rate of at least 80%), compliance with the sessions and adverse events.
2. Leicester cough questionnaire
3. The King's Brief Interstitial Lung Disease (KBILD)
4. Modified Borg scale (mBorg
5. Cough Hypersensitivity Questionnaire (CHQ)
6. Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
7. Global rating of change questionnaire (GRCQ)
8. Satisfaction Semi-structured interviews using open-ended questions will be conducted before and after the cough control intervention to capture participants' expectations and perspectives about the cough control therapy.

Eligibility criteria: Inclusion Criteria:

* Individuals will be included if having confirmed diagnosis of any ILD by a physician (as per Canadian Thoracic Society's guideline for evaluating patients with fibrotic interstitial lung disease) and a chronic cough lasting more than 8 weeks in duration

Exclusion Criteria:

* self-reports of moderate or large sputum production
* effective or suspected exacerbation of the respiratory condition in the past month
* upper respiratory tract infection in the past month
* use of angiotensin-converting enzyme inhibitor medication
* changes in the prescribed medication in the previous month
* evidence of traction bronchiectasis in the HRCT
* evidence of other medical conditions that prevent performance of an exercise training program
* unable to read or speak in English / unable to provide informed consent.

Primary outcomes:
measure: Feasibility of intervention
timeFrame: through study completion, average 1 year
Secondary outcomes:
measure: Leicester cough questionnaire
timeFrame: through study completion, average 1 year
measure: The King's Brief Interstitial Lung Disease (KBILD)
timeFrame: through study completion, average 1 year
measure: Modified Borg scale (mBorg)
timeFrame: through study completion, average 1 year
measure: Cough Hypersensitivity Questionnaire (CHQ)
timeFrame: through study completion, average 1 year
measure: Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
timeFrame: through study completion, average 1 year
measure: Global rating of change questionnaire (GRCQ)
timeFrame: through study completion, average 1 year
measure: Satisfaction of cough therapy program
timeFrame: through study completion, average 1 year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Toronto
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
References:
citation: Chamberlain Mitchell SA, Garrod R, Clark L, Douiri A, Parker SM, Ellis J, Fowler SJ, Ludlow S, Hull JH, Chung KF, Lee KK, Bellas H, Pandyan A, Birring SS. Physiotherapy, and speech and language therapy intervention for patients with refractory chronic cough: a multicentre randomised control trial. Thorax. 2017 Feb;72(2):129-136. doi: 10.1136/thoraxjnl-2016-208843. Epub 2016 Sep 28.