Interstitial Lung DiseaseCOUGH-LESSNCT06782893
Chronic COUGH Management in Interstitial Lung DisEase
A study testing Healthy lifestyle in people with Interstitial Lung Disease and Chronic Cough, run by Aveiro University at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease, Chronic Cough
- What is being tested?
- Healthy lifestyle
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 sitePortugal
- Study dates
- 20 Dec 2027to 30 Jul 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Portugal1 site
Aveiro University
Aveiro
Ana L Oliveira, +351913937469, alao@ua.pt
Ana S Grave, MSc
About this study
Official title: 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.
Read the 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.
- Conditions
- Interstitial Lung Disease, Chronic Cough
- Being tested
- Non-pharmacological cough control therapy, Healthy lifestyle
- Keywords
- Chronic Cough, Interstitial Lung Disease, Non-pharmacological cough control therapy
- Medical subject headings
- Lung Diseases, Interstitial, 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 therapyBehavioural
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.
Healthy lifestyleBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| COUGH-LESS Programme | Experimental | Not described Receives: Behavioral: Non-pharmacological cough control therapy |
| Control Group | Sham comparator | Not described Receives: Behavioral: Healthy lifestyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
The mMRC has been validated for the Portuguese population and is a predictor of increased severity in people with ILD.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: One measurement will be assessed at baseline, 7 weeks after (post-intervention) and 3 and 6 months after the intervention.
Interviews
Participants will be invited to take part in face-to-face, semi-structured individual interviews the impact of both interventions (control and experimental group).
Measured: One measurement will be assessed at baseline and 7 weeks after (post-intervention)
Adherence to the COUGH-LESS programme
Participants' number of sessions attended to the intervention will be registered.
Measured: Only one measurement will be assessed after 7 weeks after baseline (post-intervention).
Occurrence of adverse events
The occurrence of adverse events in participants will be registered according to CTCAE v4.0.
Measured: One measurement will be assessed at 7 weeks after baseline (post-intervention) and 3 and 6 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start20 Dec 2027 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung DiseaseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, Centro Hospitalar do Baixo Vouga, Centro Hospitalar de Entre o Douro e Vouga
- Responsible party
- Principal investigator, Prof Ana Oliveira, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782893
- Sponsor's protocol ID
- 2023.01387.BDANA
- Other IDs
- 2023
- Acronym
- COUGH-LESS
- Status last verified
- Jul 2024
- First submitted
- 30 Jul 2024
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COUGH-LESS: Chronic COUGH Management in Interstitial Lung DisEase - Non-pharmacological Strategies and Solutions
- ClinicalTrials.gov ID
- NCT06782893
- Acronym / sponsor ID
- COUGH-LESS / 2023.01387.BDANA
- Conditions
- Interstitial Lung Disease, Chronic Cough
- Keywords
- Chronic Cough, Interstitial Lung Disease, Non-pharmacological cough control therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia, Centro Hospitalar do Baixo Vouga, Centro Hospitalar de Entre o Douro e Vouga
- Study start
- 20 Dec 2027 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 20 Jan 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COUGH-LESS Programme | Experimental | Behavioral: Non-pharmacological cough control therapy |
| Control Group | Sham comparator | Behavioral: Healthy lifestyle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
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 therapyOver 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. | Behavioural | COUGH-LESS Programme |
| Healthy lifestyleOver 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. | Behavioural | Control Group |
Primary outcome
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.
12 secondary outcomes
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interviews
Time frame: 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).
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.
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 20 Jan 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy lifestyle in people with Interstitial Lung Disease and Chronic Cough, run by Aveiro University at 1 site in Portugal.
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 1 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: opening soon, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. 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. Some participants in this study may receive a placebo. 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 L Oliveira, PhD (00351913937469, alao@ua.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2025.