NCT06918756

Development of a Cough Control Questionnaire (CCQ)

The Development and Validation of a Cough Control Questionnaire

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: King's College Hospital NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cough

Interventions

Type	Name	Description
OTHER	Questionnaires	Completion of new questionnaire in addition to other patient reported outcome measures that measure cough severity and cough-related quality of life.
OTHER	Focus group interviews	Semi-structured focus group interviews for patients with refractory chronic cough
OTHER	Objective cough measures	Cough monitoring and cough sensitivity testing.

Timeline

• Start date: 2025-04-01
• Primary completion: 2031-09-01
• Completion: 2031-09-01
• First posted: 2025-04-09
• Last updated: 2025-04-09

Locations

1 site across 1 country: United Kingdom