Cough Suppressive Therapy in Patients With Chronic Cough

Chronic Cough Clinical Trial

Official title:

Cough Suppressive Therapy in Chronic Cough: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05522699
• Other study ID #: 974599
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: Uppsala University
• Contact: Principal investigator, Phd
• Phone: +46186110000
• Email: lungforskning[@]akademiska.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Cough
• Cough

Intervention

Behavioral:
• Cough 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).
• General healthy lifestyle instructions
The general healthy lifestyle instructions are based on the recommendations from the The Public Health Agency of Sweden.

Locations

Country	Name	City	State
Sweden	Uppsala Academical Hopsital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Change in Cough frequency	24 hour consecutive recording of cough frequency in home environment	Change from baseline cough frequency at one week and 6 months after completed intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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