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The Development and Validation of a Cough Control Questionnaire
Chronic cough (\>8 weeks in duration) affects 5-12% of the global population, and is associated with considerable health status impairment and comorbidities. Currently, there are validated severity and impact outcome measures whilst objective measures with cough frequency monitoring is not available in routine clinical practice. Unlike other chronic respiratory diseases, namely asthma, there are no validated dedicated tools to assess the control of cough as a disease. This study aims to develop a validated patient-focused tool to assess the control of cough, which may be useful to evaluate the benefit and value of treatments in both clinical and research settings.
This study will involve 3 phases: * Phase 1: Literature review. Review of currently available validated tools to assess control in respiratory diseases. * Phase 2: Development of Cough Control Questionnaire (CCQ). Patient focus groups will aid development of a conceptual framework of cough control and ensure content validity through qualitative research methods including thematic analysis. Expert panel review of cough control framework will also be undertaken. CCQ item development will be grounded in patient focus groups and expert review findings, and reviewed through cognitive debrief with patients. * Phase 3: Validation of CCQ. Prospective consecutive patients with chronic cough will complete CCQ, cough severity assessments and health status assessments. Patients will be invited to undergo objective cough frequency monitoring and cough challenge testing.
Age
18 - 100 years
Sex
ALL
Healthy Volunteers
No
King's College Hospital
London, United Kingdom
Start Date
April 1, 2025
Primary Completion Date
September 1, 2031
Completion Date
September 1, 2031
Last Updated
April 9, 2025
100
ESTIMATED participants
Questionnaires
OTHER
Focus group interviews
OTHER
Objective cough measures
OTHER
Lead Sponsor
King's College Hospital NHS Trust
NCT05665244
NCT05989698
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07112144