CoughNCT04767074
A Non-pharmacological Cough Control Therapy
A study of Cough and ILD, run by West Park Healthcare Centre at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cough, ILD, Pulmonary Disease
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Sep 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
Ana Oliveira, PhD, ana.oliveira@westpark.org
Dina Brooks, PhD, 4165058953, brookd8@mcmaster.ca
- Recruiting
West Park Healthcare Centre
Toronto, Ontario, M6M 2J5
Ana Oliveria, PhD, 6477651525, ana.oliveira@westpark.org
Shirley Quach, Shirley.Quach@westpark.org
About this study
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).
Read the detailed description
Research questions and hypotheses
- 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.
- 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.
- Leicester cough questionnaire
- The King's Brief Interstitial Lung Disease (KBILD)
- Modified Borg scale (mBorg
- Cough Hypersensitivity Questionnaire (CHQ)
- Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
- Global rating of change questionnaire (GRCQ)
- 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.
- Conditions
- Cough, ILD, Pulmonary Disease, Pulmonary Fibrosis
- Being tested
- Non-pharmacological Cough control Therapy
- Keywords
- Cough, ILD, Pulmonary rehabilitation, chronic cough, non-pharmacological cough therapy
- Medical subject headings
- Cough, Lung Diseases, Pulmonary Fibrosis, Chronic Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-pharmacological Cough control TherapyOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Non-pharmacological Cough control Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, average 1 year
Secondary outcomes (7)
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.
Measured: through study completion, average 1 year
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.
Measured: through study completion, average 1 year
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.
Measured: through study completion, average 1 year
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.
Measured: through study completion, average 1 year
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).
Measured: through study completion, average 1 year
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).
Measured: through study completion, average 1 year
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).
Measured: through study completion, average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Sep 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility Pre/Post interventional study
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Park Healthcare Centre
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Responsible party
- Principal investigator, Dina Brooks, West Park Healthcare Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04767074
- Sponsor's protocol ID
- 20-005-WP
- Status last verified
- Mar 2025
- First submitted
- 18 Feb 2021
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27682331
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04767074
- Acronym / sponsor ID
- 20-005-WP
- Conditions
- Cough, ILD, Pulmonary Disease, Pulmonary Fibrosis
- Keywords
- Cough, ILD, Pulmonary rehabilitation, chronic cough, non-pharmacological cough therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- West Park Healthcare CentreUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Research questions and hypotheses
- 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.
- 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.
- Leicester cough questionnaire
- The King's Brief Interstitial Lung Disease (KBILD)
- Modified Borg scale (mBorg
- Cough Hypersensitivity Questionnaire (CHQ)
- Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
- Global rating of change questionnaire (GRCQ)
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility Pre/Post interventional study
| Arm | Type | Receives |
|---|---|---|
| Non-pharmacological Cough control therapy | Experimental | Other: Non-pharmacological Cough control TherapyParticipants 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 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-pharmacological Cough control TherapyAlso: Cough Control therapyParticipants 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. | Other | Non-pharmacological Cough control therapy |
Primary outcome
Feasibility of intervention
Time frame: through study completion, average 1 year
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.
7 secondary outcomes
Leicester cough questionnaire
Time frame: through study completion, average 1 year
The King's Brief Interstitial Lung Disease (KBILD)
Time frame: through study completion, average 1 year
Modified Borg scale (mBorg)
Time frame: through study completion, average 1 year
Cough Hypersensitivity Questionnaire (CHQ)
Time frame: through study completion, average 1 year
Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-F)
Time frame: through study completion, average 1 year
Global rating of change questionnaire (GRCQ)
Time frame: through study completion, average 1 year
Satisfaction of cough therapy program
Time frame: through study completion, average 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Background: PubMed 27682331Chamberlain 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.
- Evaluation of patients living with fibrotic interstitial lung diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Cough
Recruiting
Feasibility of Cough Skill Training in Individuals With Head and Neck Cancer
Head and Neck Cancers
Recruiting
Feasibility, Acceptability, and Safety Trial of Brief, Breath Control-Focused Acceptance and Commitment Therapy in Adults With Chronic Cough
Chronic Cough
RecruitingPhase 4
Remifentanil Versus Remifentanil-Lidocaine for Tracheal Extubation After Thyroidectomy
Tracheal Extubation, Cough
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Cough and ILD, run by West Park Healthcare Centre at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ana Oliveira, PhD (6477651525, ana.oliveira@westpark.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of intervention (time frame: through study completion, average 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04767074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.