Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT06918756
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of a Cough Control Questionnaire (CCQ)
Sponsor:
King's College Hospital NHS Trust
Organization:
Study Overview
Official Title:
The Development and Validation of a Cough Control Questionnaire
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCQ
Brief 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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: