A Non-pharmacological Cough Control Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWest Park Healthcare Centre
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Non-pharmacological Cough control Therapy
Other interventionParticipants 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.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Non-pharmacological Cough control therapyExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
through study completion, average 1 yearSecondary outcomes
1
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.
Time frame
through study completion, average 1 year2
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.
Time frame
through study completion, average 1 year3
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.
Time frame
through study completion, average 1 year4
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.
Time frame
through study completion, average 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
West Park Healthcare Centre
Lead sponsor
St. Joseph's Healthcare Hamilton
Collaborator
Source ClinicalTrials.gov