A Non-pharmacological Cough Control Therapy

Study Purpose

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.

NCT04767074
Phase

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.

OtherOther
Overall Status Recruiting
Countries Canada
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cough, ILD, Pulmonary Disease, Pulmonary Fibrosis
Study Website: View Trial Website
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

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International Sites

Ana Oliveira, Toronto, Ontario, Canada

Status

Recruiting

Address

Ana Oliveira

Toronto, Ontario, M6M 2J5

Site Contact

Ana Oliveira, PhD

ana.oliveira@westpark.org

6477651525

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