Chronic Cough
Conditions
Brief summary
In this randomized, placebo-controlled, interventional study on chronic cough a non-pharmacological cough suppressive therapy is the intervention to be studied, with a control group receiving treatment consisting of general healthy lifestyle advice. The following data will be collected before, after and up to six months after treatment: Standardized questionnaires for diagnosis of background factors, Leicester Cough Questionnaire (LCQ), Work Ability Index (WAI), and cough frequency as well as lung function and biomarkers. The primary treatment effect measurement will be changes in chronic cough-related quality of life, measured by the Leicester Cough Questionnaire (LCQ).
Detailed description
The study will be carried out in collaboration between respiratory physicians, clinical physiologists, physiotherapists, speech- and language therapists and gastroenterologists. The primary hypothesis of the planned study is: The cough suppressive therapy improves chronic cough-related quality of life and work ability, and is sustained over six months after treatment. The secondary hypotheses of the planned study are: Treatment of chronic cough by the cough suppressive therapy can reduce cough frequency (measured by an automated cough detector), airway inflammation and airway resistance. Baseline differences in clinical findings, biomarkers and physiologic measurements predict different treatment effects. The following data will be collected before and after treatment: * Standardized questionnaires for diagnosis of background factors and cough duration, LCQ, WAI, questions on sick leave days, voice disturbance questionnaire. * Physiological measurements: Spirometry with reversibility test, impulse oscillometry before and after provocation with hypertonic saline inhalation. 24 hours cough frequency analysis, voice analysis. * Biomarkers: Fractional exhaled nitric oxide (FeNO), blood-eosinophils and eosinophil cationic protein in serum, proteomics in particles in exhaled air (PExA)
Interventions
BEHAVIORALCough suppressive therapy
The cough suppressive therapy based on the treatment regime Physiotherapy, and speech and language therapy intervention for patients with refractory chronic cough (PSALTI) developed by S. Chamberlain et al (Thorax. 2017 Feb;72(2):129-136).
BEHAVIORALGeneral healthy lifestyle instructions
The general healthy lifestyle instructions are based on the recommendations from the The Public Health Agency of Sweden.
Sponsors
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Chronic cough (duration \>2 months) without a structural lung disease and a normal chest X-ray, which have failed pharmacological treatment. * Being able to understand the swedish language.
Exclusion criteria
* Pulmonary abnormalities on a chest X-ray, structural lung disease, or chronic obstructive pulmonary disease (COPD) of spirometry stage Global Initiative for Obstructive Lung Disease (GOLD) 2 or higher. * Smoking under the last three months. * Ongoing or recent treatment with angiotensin-converting enzyme (ACE) inhibitor * Active aspiration, vocal cord nodules or upper respiratory tract infection in the previous 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Leicester Cough Questionnaire (LCQ) | Change from baseline LCQ at one week and 6 months after completed intervention | Leicester Cough Questionnaire (LCQ) is an English-born self-reporting quality of life measure of chronic cough, |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cough frequency | Change from baseline cough frequency at one week and 6 months after completed intervention | 24 hour consecutive recording of cough frequency in home environment |
| Change in the hypersensitivity of the cough reflex | Change from baseline hypersensitivity of the cough reflex at one week after completed intervention | Standardised provocation test with inhaled hypertonic saline |
| Change in The Work Ability Index (WAI) | Change from baseline WAI at one week and 6 months after completed intervention | WAI is a questionnaire, which serves to conduct a self-assessment. The focus is on the employees and their work ability assessed by themselves |
| Change in inflammation biomarker fractional exhaled nitric oxide (FeNO) | Change from baseline FeNo at one week after completed intervention | Measured exhaled nitric oxide (NO) at 50 mL/s using a chemiluminescence NO analyzer. |
| Change in inflammation biomarkers in blood; level of eosinophil cationic protein (ECP) | Change from baseline inflammation biomarkers in blood (ECP) at one week after completed intervention | Blood samples for ECP (mcg/l) |
| Change in inflammation biomarkers in blood; eosinophil count | Change from baseline inflammation biomarkers (eosinophil count) in blood at one week after completed intervention | Blood samples for eosinophil count, (cells/l) |
Countries
Sweden
Contacts
Primary ContactPrincipal investigator, Phd
Outcome results
None listed