Clinical trial NCT05522699: Cough Suppressive Therapy in Patients With Chronic Cough
Official title: Cough Suppressive Therapy in Chronic Cough: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Cough
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2022-08-31
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Leicester Cough Questionnaire (LCQ)
timeFrame: Change from baseline LCQ at one week and 6 months after completed intervention
Secondary outcomes:
measure: Change in The Work Ability Index (WAI)
timeFrame: Change from baseline WAI at one week and 6 months after completed intervention
measure: Change in Cough frequency
timeFrame: Change from baseline cough frequency at one week and 6 months after completed intervention
measure: Change in the hypersensitivity of the cough reflex
timeFrame: Change from baseline hypersensitivity of the cough reflex at one week after completed intervention
measure: Change in inflammation biomarkers in blood; eosinophil count
timeFrame: Change from baseline inflammation biomarkers (eosinophil count) in blood at one week after completed intervention
measure: Change in inflammation biomarker fractional exhaled nitric oxide (FeNO)
timeFrame: Change from baseline FeNo at one week after completed intervention
measure: Change in inflammation biomarkers in blood; level of eosinophil cationic protein (ECP)
timeFrame: Change from baseline inflammation biomarkers in blood (ECP) at one week after completed intervention
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala Academical Hopsital
Study officials:
affiliation: Uppsala Academical Hospital, Uppsala, Sweden
name: Helen Wallstedt
role: STUDY_DIRECTOR
References: