Cough Clinical Trial
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
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).
Status | Recruiting |
Enrollment | 24 |
Est. completion date | December 2024 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | St. Joseph's Healthcare Hamilton | Hamilton | Ontario |
Canada | West Park Healthcare Centre | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
West Park Healthcare Centre | St. Joseph's Healthcare Hamilton |
Canada,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of intervention | intervention 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. | through study completion, average 1 year | |
Secondary | Leicester cough questionnaire | The LCQ is a validated 19-item cough-specific HRQoL questionnaire. It is divided into 3 domains (physical, social and psychological) and the overall score range from 3 to 21, with a higher score indicating a better cough related HRQOL. | through study completion, average 1 year | |
Secondary | The King's Brief Interstitial Lung Disease (KBILD) | The KBILD is a self-completed health status questionnaire that comprises of 15 items with the following three domains: psychological, breathlessness and activities and chest symptoms. Total score ranges from 0 to 100; 100 representing the best health status. This KBILD has an established minimal clinically important difference of 5-points in people with ILD. | through study completion, average 1 year | |
Secondary | Modified Borg scale (mBorg) | The modified Borg scale is widely used to assess the intensity of dyspnoea in individuals with chronic respiratory diseases and has recently been successfully adopted to assess the urge to cough and severity of cough in this population. The mBorg is measured on a 10 point scale; with 0 as feelings of "nothing at all" (no signs of dyspnoea) to 10 as "very very hard" intensity of dyspnoea. | through study completion, average 1 year | |
Secondary | Cough Hypersensitivity Questionnaire (CHQ) | The presence of triggers and laryngeal symptoms associated with cough were recorded using a standardized novel questionnaire, the CHQ. The CHQ comprises 23 items related to cough triggers, urge and laryngeal sensations associated with cough. | through study completion, average 1 year | |
Secondary | Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F) | The FACIT-F is, a multi-dimensional 13-item questionnaire assessing tiredness, weakness and difficulty in handling daily living activities due to fatigue, over the previous 7 days. Participants are asked to rate their level of fatigue on a 4-point scale, where 0-not very much to 4- very much so. The sum of these values will provide a FACIT-F score ranging 0 to 52 (less fatigue to most fatigue). | through study completion, average 1 year | |
Secondary | Global rating of change questionnaire (GRCQ) | The GRCQ is a 15-point scale widely used to determine the participants' and health. professionals' perceptions about cough changes after interventions. Participants will be asked to rate global changes in cough in a scale ranging from -7 (a great deal worse) to +7 (a great deal better). | through study completion, average 1 year | |
Secondary | Satisfaction of cough therapy program | Participants' satisfaction and perceived benefits will be evaluated following completion of the intervention participants with a 9-item survey previously used to assess interventions in chronic respiratory diseases. The survey asks participants to report their level of agreement with statements on enjoyment and perceived improvements/benefits according to a 5-point Likert type scale (1=strongly agree; 5=strongly disagree). | through study completion, average 1 year |
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