Chronic COUGH Management in Interstitial Lung DisEase (COUGH-LESS)

January 14, 2025 updated by: Prof Ana Oliveira, Aveiro University

COUGH-LESS: Chronic COUGH Management in Interstitial Lung DisEase - Non-pharmacological Strategies and Solutions

Interstitial Lung Disease (ILD) includes chronic, disabling and progressive respiratory conditions marked by lung inflammation and fibrosis. The quality of life and functionality of people with ILD is affected by a plethora of debilitating symptoms such as dyspnoea fatigue and cough. Among them, chronic cough (a cough lasting more than 8 weeks) reigns as one of the most prevalent and challenging, despite receiving far less attention from researchers than other symptoms. Chronic cough affects up to 8 out of 10 individuals with ILD and it is associated with a worse prognosis, mortality, and the need for lung transplantation. This condition showed a significant impact in people's life (e.g., urinary incontinence, speech interferences, depression, chest pain, couples sleeping in separate bedrooms, avoidance of public areas, reduced social interaction, and work absenteeism), further contributing to the decreased health-related quality of life experienced by this population. Managing chronic cough is, therefore, urgently needed. The general aim of this study is to explore the effects of a non-pharmacological cough control treatment on cough-related quality of life in people with ILD. The specific aims of this study are: i) to explore short- and mid-term effects of the non-pharmacological cough control treatment on cough related outcomes (e.g., cough frequency and intensity, dyspnoea, fatigue, cough self-efficacy, health-related quality of life and emotional status); ii) to identify (if any) adverse effects of this therapy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Interstitial Lung Disease (ILD) comprises chronic, disabling, and progressive respiratory conditions marked by lung inflammation and fibrosis. The quality of life and functionality of people with ILD is affected by a plethora of debilitating symptoms such as dyspnoea, fatigue, and cough. Among them, chronic cough reigns as one of the most prevalent and challenging, despite receiving far less attention from researchers than other symptoms.

Chronic cough (a cough lasting for > 8 weeks) and affects up to 8 out of 10 individuals with ILD. It is associated with a worse prognosis, mortality, and the need for lung transplantation. This condition also causes urinary incontinence, interferes with speech, and presents psychosocial and physical manifestations, such as depression and chest pain. Chronic cough can also lead to relationship problems, such as couples sleeping in separate bedrooms, avoidance of public areas, reduced social interaction, and work absenteeism, further contributing to the decreased health-related quality of life experienced by this population. Managing chronic cough is, therefore, urgently needed.

Currently, there is no approved drug to manage chronic cough in people with ILD. Conversely, non-pharmacologic cough control therapies have demonstrated similar efficacy without side effects. Studies have shown that non-pharmacological cough control therapy can improve cough-related quality of life and reduce cough frequency in individuals with refractory (i.e., cough that lasts despite optimal treatment) chronic cough. Promising results were observed in a case-study on people with chronic cough and ILD. However, well-designed randomized controlled trials (RCTs) with adequate power are needed to establish the effects of non-pharmacological cough control therapy on people with ILD.

The primary aim of this study is to explore the effects of a non-pharmacological cough control treatment on cough-related quality of life in people with ILD. The specific aims of this study are: i) to explore short- and mid-term effects of the non-pharmacological cough control treatment on cough related outcomes (e.g., cough frequency and intensity, dyspnea, fatigue, cough self-efficacy, health-related quality of life and emotional status); ii) to identify (if any) adverse effects of this therapy.

COUGH-LESS randomized trial Potential participants will be identified and recruited through the pulmonology services of the Centro Hospitalar do Baixo Vouga (CHBV) and Centro Hospitalar de Entre-o-Douro e Vouga (CHEDV).

Study design Participants will be randomly assigned to an experimental (EG) or control group (CG) using an online software. Assessments will be conducted at baseline, post-intervention and 3 and 6 months after the intervention. To detect a 2-point between-group difference in the LCQ after 5 weeks, 20 participants per group (n=40) will be required, with 80% power and a significance level of 5%. Previous studies indicate losses to follow up of 50% and thus we will aim to recruit 60 individuals.

Data collection Assessments will be conducted at baseline, post-intervention and 3 and 6 months after the intervention.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ana L Oliveira, PhD
  • Phone Number: 00351913937469
  • Email: alao@ua.pt

Study Contact Backup

  • Name: Alda Marques, PhD
  • Phone Number: 27121 00351234372462
  • Email: amarques@ua.pt

Study Locations

  • Portugal
      • Aveiro, Portugal
        • Aveiro University
        • Contact:
          • Ana L Oliveira
          • Phone Number: +351913937469
          • Email: alao@ua.pt
        • Contact:
          • Ana S Grave, MSc
        • Contact:
          • Alda Marques, PhD
        • Contact:
          • Diogo Tecelão, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

i) Adults (>18 years old) ii) Clinical diagnosis of ILD iii) Presenting chronic cough (> 8 weeks of duration) iv) People with access to a virtual meeting platform/telephone.

Exclusion Criteria:

i) Self-reports of moderate or large sputum production (> 2 tablespoons); ii) Actual or suspected exacerbation of the respiratory condition in the last month; iii) Upper respiratory tract infection (e.g. cold); iv) Use of angiotensin-converting enzyme inhibitor medication; v) Changes in prescribed medication in the last month; vi) Signs of cognitive impairment or significant cardiovascular, neurological and/or musculoskeletal disease that may limit participation in the program; vii) Inability to read or speak Portuguese; viii) Inability to provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Control Group
Behavioral: Healthy lifestyle
Over seven weeks (1 session per week, except session 5, which will be 2 weeks after session 4) using a one-on-one hybrid model. In session 1, participants will receive general education about exercise and physical activity. Session 2 will cover education about diet. Session 3 will focus on stress management. Session 4 will cover relaxation techniques, and session 5 will reinforce all aspects previously considered.
Experimental: COUGH-LESS Programme
Behavioral: Non-pharmacological cough control therapy
Over seven weeks (1 session per week, except session 5, which will be 2 weeks after session 4) using a one-on-one hybrid model. In session 1, participants will receive general education about chronic cough, introduction to cough suppression and goal setting. Session 2 will cover education about chronic cough in ILD, cough triggers and training in cough suppression techniques. Session 3 will focus on hydration techniques, laryngeal hygiene, and breathing exercises to control coughing. Session 4 will reinforce all aspects of non-pharmacological cough control treatment, and session 5 will explore the sustainability of cough control strategies after the program using real-life case scenarios.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Leicester Cough Questionnaire (LCQ)
Time Frame: One measurement will be assessed at baseline, 7 weeks after interventions and 3 and 6 months after the intervention.
The LCQ is a reliable, responsive questionnaire recommended by various guidelines for assessing chronic cough. This questionnaire comprises 21 questions referring to the two weeks prior to completing it. The LCQ assesses three domains (psychological, social and physical) and also gives a total score. The maximum score that can be obtained on the LCQ is 21 points in total (7 in each domain) where higher scores translate into a higher quality of life related to coughing.
One measurement will be assessed at baseline, 7 weeks after interventions and 3 and 6 months after the intervention.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Modified British Medical Research Council Dyspnea Scale (mMRC)
Time Frame: One measurement will be assessed at baseline, 7 weeks after interventions and 3 and 6 months after the intervention.
The mMRC has been validated for the Portuguese population and is a predictor of increased severity in people with ILD.
One measurement will be assessed at baseline, 7 weeks after interventions and 3 and 6 months after the intervention.
Change in Cough Visual Analogic Scale (CVAS)
Time Frame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
The CVAS will be used to measure intensity and frequency of cough. This scale consists of a 10 cm line ranging from 0 (no severity/intensity) to 10 (extreme severity/intensity) and is moderately responsive.
One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
Change in Chronic Airways Assessment Test (CAAT)
Time Frame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
CAT will be used to measure quality of life related to respiratory symptoms. This scale ranges from 0 to 45, where higher values mean a lower quality of life related to respiratory symptoms in people with ILD.
One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
Change in One minute sit-to-stand test (1min-STS)
Time Frame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
The 1min-STS will be used to assess functional capacity. It will be counted the maximum number of repetitions completed in 1 minute while sitting and standing on a chair.
One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
Six-minute Walking Test (6MWT)
Time Frame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
The 6MWT will be used also to measure functional capacity and has been validated in people with ILD. The walked total distance during the six minutes will be counted.
One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
Change in Cough Hypersensitivity Questionnaire (CHQ)
Time Frame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
The CHQ comprises 23 questions related to cough-causing stimuli and coughing sensations. This questionnaire scores rages from 0 to 23 points, where higher scores mean a greater presence and severity of stimuli and triggers of cough and sensations in the larynx.
One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
Change in Hospital Anxiety and Depression Scale (HADS)
Time Frame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
HADS is an easy-to-use scale that is subdivided into two domains (anxiety symptoms and depressive symptoms). Their score varies from 0 to 21 in each subdomain, where a score between 0 and 7 is considered 'normal', between 8 and 10 indicates a "mild" level, between 11 and 14 a "moderate" level, and between 15 and 21 "severe" levels of anxiety and depression symptoms.
One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
Change in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS)
Time Frame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
FACIT-FS assesses fatigue where a higher score translates into lower fatigue. This scale is commonly used in the ILD population to assess fatigue, presenting good reliability and feasibility.
One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
Change in King's Brief Interstitial Lung Disease (K-BILD)
Time Frame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
K-BILD will be used to assess health related quality of life. This scale encompasses three domains: psychological, dyspnoea, activities, and respiratory symptoms where higher scores define a high health related quality of life.
One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
Interviews
Time Frame: One measurement will be assessed at baseline and 7 weeks after (post-intervention)
Participants will be invited to take part in face-to-face, semi-structured individual interviews the impact of both interventions (control and experimental group).
One measurement will be assessed at baseline and 7 weeks after (post-intervention)
Adherence to the COUGH-LESS programme
Time Frame: Only one measurement will be assessed after 7 weeks after baseline (post-intervention).
Participants' number of sessions attended to the intervention will be registered.
Only one measurement will be assessed after 7 weeks after baseline (post-intervention).
Occurrence of adverse events
Time Frame: One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.
The occurrence of adverse events in participants will be registered according to CTCAE v4.0.
One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in number of hospitalizations
Time Frame: One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.
Patients' number of hospitalizations in the previous year and during the follow-up period, as well as the length of stay for each hospitalization, will be assessed by asking the patient to self-report.
One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.
Change in acute exacerbations
Time Frame: One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.
Patients' number of acute exacerbations will be assessed by asking the patient to self-report.
One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.
Interstitial Lung Disease- Gender, Age and Physiology model (ILD-GAP model)
Time Frame: Only one measurement will be assessed on baseline. This will be used as a descriptive measure.
ILD-GAP model measures the severity of the disease based on the diagnosis, sex and respiratory function test values to create a score that can vary between 0 and 8. The greater the severity of the disease, the higher the ILD-GAP model.
Only one measurement will be assessed on baseline. This will be used as a descriptive measure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aveiro University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centro Hospitalar de Entre o Douro e Vouga
Fundação para a Ciência e a Tecnologia
Centro Hospitalar do Baixo Vouga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2027

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023.01387.BDANA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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