Chronic COUGH Management in Interstitial Lung DisEase

NCT06782893 | Not Yet Recruiting

• 1 other identifier: 2023.01387.BDANA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease; Chronic Cough

Keywords

Chronic Cough; Interstitial Lung Disease; Non-pharmacological cough control therapy

Outcome Measures

Primary Outcomes (1)

• Change in Leicester Cough Questionnaire (LCQ)

  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 Outcomes (12)

• Change in Modified British Medical Research Council Dyspnea Scale (mMRC)

  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)

  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)

  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)

  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)

  One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.

Other Outcomes (3)

• Change in number of hospitalizations

  One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.

• Change in acute exacerbations

  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)

  Only one measurement will be assessed on baseline. This will be used as a descriptive measure.

Study Arms (2)

COUGH-LESS Programme

EXPERIMENTAL

Behavioral: Non-pharmacological cough control therapy

Control Group

SHAM COMPARATOR

Behavioral: Healthy lifestyle

Interventions

Non-pharmacological cough control therapy BEHAVIORAL

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.

COUGH-LESS Programme

Healthy lifestyle BEHAVIORAL

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.

Control Group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aveiro University: lead
• Fundação para a Ciência e a Tecnologia: collaborator
• Centro Hospitalar do Baixo Vouga: collaborator
• Centro Hospitalar de Entre o Douro e Vouga: collaborator

Study Sites (1)

Aveiro University

Aveiro, Portugal

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial; Chronic Cough

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Cough; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ana L Oliveira, PhD

CONTACT

00351913937469; alao@ua.pt

Alda Marques, PhD

CONTACT

00351234372462; amarques@ua.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: January 20, 2025
• Study Start (Estimated): December 20, 2027
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): July 30, 2028
• Last Updated: January 20, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)