A Non-pharmacological Cough Control Therapy

NCT04767074 | Recruiting

• 1 other identifier: 20-005-WP
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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).

Conditions

Cough; ILD; Pulmonary Disease; Pulmonary Fibrosis

Keywords

Cough; ILD; Pulmonary rehabilitation; chronic cough; non-pharmacological cough therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Leicester cough questionnaire

  through study completion, average 1 year

• The King's Brief Interstitial Lung Disease (KBILD)

  through study completion, average 1 year

• Modified Borg scale (mBorg)

  through study completion, average 1 year

• Cough Hypersensitivity Questionnaire (CHQ)

  through study completion, average 1 year

• Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)

  through study completion, average 1 year

Study Arms (1)

Non-pharmacological Cough control therapy

EXPERIMENTAL

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

Other: Non-pharmacological Cough control Therapy

Interventions

Non-pharmacological Cough control Therapy OTHER

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.

Also known as: Cough Control therapy

Non-pharmacological Cough control therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• West Park Healthcare Centre: lead
• St. Joseph's Healthcare Hamilton: collaborator

Study Sites (2)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

RECRUITING

West Park Healthcare Centre

Toronto, Ontario, M6M 2J5, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 27682331 BACKGROUND

MeSH Terms

Conditions

Cough; Lung Diseases; Pulmonary Fibrosis; Chronic Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Lung Diseases, Interstitial; Fibrosis; Pathologic Processes

Central Study Contacts

Ana Oliveira, PhD

CONTACT

6477651525; ana.oliveira@westpark.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Scientist

Model Details: Feasibility Pre/Post interventional study

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 23, 2021
• Study Start: September 1, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)