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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cough suppressive therapy | Experimental | The cough suppressive therapy consists of four one-to-one treatment sessions, 45 minutes per session, over a 2 months period. The sessions include patient education about chronic cough; negative effects of repeated cough as well as patient education of voluntary control of cough; identification of cough triggers and learning cough suppression techniques, and psychoeducational counselling including patient self-motivation, repetition of aims and techniques, behavior modification regarding over-awareness of the need to cough. The sessions will be conducted by a specially trained physiotherapist or speech and language therapist. All components of the cough suppressive therapy will be delivered to each participant but the focus and emphasis on individual techniques will be individually tailored for each participant, determined by the physio- or speech and language therapist together with the participant. |
|
| Healthy lifestyle instructions | Active Comparator | The Healthy lifestyle instructions consists of four one-to-one treatment sessions, 30 minutes per session, over a 2 months period. The sessions will be conducted by a specially trained physiotherapist or speech and language therapist. The sessions include patient education and motivational conversation about healthy eating habits, physical activity, stress and relaxation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cough suppressive therapy | Behavioral | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Leicester Cough Questionnaire (LCQ) | Leicester Cough Questionnaire (LCQ) is an English-born self-reporting quality of life measure of chronic cough, | Change from baseline LCQ at one week and 6 months after completed intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in The Work Ability Index (WAI) | 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 from baseline WAI at one week and 6 months after completed intervention |
| Change in Cough frequency |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Principal investigator, Phd | Contact | +46186110000 | lungforskning@akademiska.se |
| Name | Affiliation | Role |
|---|---|---|
| Helen Wallstedt | Uppsala Academical Hospital, Uppsala, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala Academical Hopsital | Recruiting | Uppsala | 75185 | Sweden |
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| ID | Term |
|---|---|
| D000096822 | Chronic Cough |
| ID | Term |
|---|---|
| D003371 | Cough |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
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|
| General healthy lifestyle instructions | Behavioral | The general healthy lifestyle instructions are based on the recommendations from the The Public Health Agency of Sweden. |
|
24 hour consecutive recording of cough frequency in home environment |
| Change from baseline cough frequency at one week and 6 months after completed intervention |
| Change in the hypersensitivity of the cough reflex | Standardised provocation test with inhaled hypertonic saline | Change from baseline hypersensitivity of the cough reflex at one week after completed intervention |
| Change in inflammation biomarkers in blood; eosinophil count | Blood samples for eosinophil count, (cells/l) | Change from baseline inflammation biomarkers (eosinophil count) in blood at one week after completed intervention |
| Change in inflammation biomarker fractional exhaled nitric oxide (FeNO) | Measured exhaled nitric oxide (NO) at 50 mL/s using a chemiluminescence NO analyzer. | Change from baseline FeNo at one week after completed intervention |
| Change in inflammation biomarkers in blood; level of eosinophil cationic protein (ECP) | Blood samples for ECP (mcg/l) | Change from baseline inflammation biomarkers in blood (ECP) at one week after completed intervention |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |