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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).
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years - 85 Years
Gender
All
More Inclusion & Exclusion 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.
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
N/A
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
West Park Healthcare Centre
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
N/A
Principal Investigator Affiliation
N/A
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Other
Overall Status
Recruiting
Countries
Canada
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Cough, ILD, Pulmonary Disease, Pulmonary Fibrosis
Additional Details
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.
Arms & Interventions
Arms
Experimental: Non-pharmacological Cough control therapy
Participants will attend four virtual sessions of 45 to 60 minutes of educational and self-management. Sessions will be designed to target participants' needs and expectations according to the semi-structured theme.
Session 1 General assessment Prescription of cough technique
Session 2 Cough principles of cough Cough control
Session 3 Breathing pattern retraining and laryngeal hygiene
Session 4 Reinforcement of cough control therapies
Interventions
Other: - Non-pharmacological Cough control Therapy
Participants will attend four virtual sessions of 45 to 60 minutes of educational and self-management.
Session 1 General assessment Prescription and taught of one cough suppression technique.
Session 2 Cough principles: mechanism, cough reflex, chronic cough, the importance of cough and negative effects of repeated coughing.
Cough control: identify triggers, use cough suppressions and distractions techniques.
Session 3 Breathing pattern retraining and laryngeal hygiene: reinforce nasal breathing and pursed lips breathing as strategies to avoid the urge to cough, identification of risk factors for laryngeal dehydration and hydration education.
Session 4 Reinforcement: Clarification of doubts, techniques' reinforcement and application during daily life situations.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
International Sites
St. Joseph's Healthcare Hamilton, Hamilton, Ontario, Canada
