Clinical trial NCT06782893: Chronic COUGH Management in Interstitial Lung DisEase
Official title: COUGH-LESS: Chronic COUGH Management in Interstitial Lung DisEase - Non-pharmacological Strategies and Solutions
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Interstitial Lung Disease
Chronic Cough
Keywords: Chronic Cough
Interstitial Lung Disease
Non-pharmacological cough control therapy
Lead sponsor: Aveiro University
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: Centro Hospitalar do Baixo Vouga
name: Centro Hospitalar de Entre o Douro e Vouga
First posted: 2025-01-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Leicester Cough Questionnaire (LCQ)
timeFrame: One measurement will be assessed at baseline, 7 weeks after interventions and 3 and 6 months after the intervention.
Secondary outcomes:
measure: Change in Modified British Medical Research Council Dyspnea Scale (mMRC)
timeFrame: One measurement will be assessed at baseline, 7 weeks after interventions and 3 and 6 months after the intervention.
measure: Change in Cough Visual Analogic Scale (CVAS)
timeFrame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
measure: Change in Chronic Airways Assessment Test (CAAT)
timeFrame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
measure: Change in One minute sit-to-stand test (1min-STS)
timeFrame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
measure: Six-minute Walking Test (6MWT)
timeFrame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
measure: Change in Cough Hypersensitivity Questionnaire (CHQ)
timeFrame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
measure: Change in Hospital Anxiety and Depression Scale (HADS)
timeFrame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
measure: Change in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-FS)
timeFrame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
measure: Change in King's Brief Interstitial Lung Disease (K-BILD)
timeFrame: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
measure: Interviews
timeFrame: One measurement will be assessed at baseline and 7 weeks after (post-intervention)
measure: Adherence to the COUGH-LESS programme
timeFrame: Only one measurement will be assessed after 7 weeks after baseline (post-intervention).
measure: Occurrence of adverse events
timeFrame: One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.
Other outcomes:
measure: Change in number of hospitalizations
timeFrame: One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.
measure: Change in acute exacerbations
timeFrame: One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.
measure: Interstitial Lung Disease- Gender, Age and Physiology model (ILD-GAP model)
timeFrame: Only one measurement will be assessed on baseline. This will be used as a descriptive measure.
Locations:
city: Aveiro
country: Portugal
facility: Aveiro University
Study officials:
References: