Development of a Cough Control Questionnaire (CCQ) (CCQ)

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.

Study Overview

• Status: Recruiting
• Conditions: Cough
• Intervention / Treatment: Other: Focus group interviews; Other: Questionnaires; Other: Objective cough measures

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • King's College Hospital
    • Contact: Ewan Mackay, MBBS, BSc, MRCP; Phone Number: 31096 02032999000; Email: ewan.mackay@nhs.net
    • Contact: Katie Rhatigan, MSc; Phone Number: 31096 02032999000; Email: k.rhatigan@nhs.net
    • Contact: Surinder Birring, MB ChB, BSc, MD, MRCP
    • Contact: Ewan Mackay, MBBS, BSc, MRCP
    • Contact: Peter Cho, MBBS, PhD, MRCP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients will be recruited from tertiary chronic cough clinics.

Description

Inclusion Criteria:

• Adult patients aged 18 and over with acute and chronic cough (including refractory chronic cough and unexplained chronic cough) and able to read and write in English. A smaller number (n =20) of healthy volunteers will also be included with no evidence of significant respiratory disease.

Exclusion Criteria:

• Current smokers (or smoking within the last 12 months), respiratory tract infection within the last 4 weeks, use of angiotensin converting enzyme inhibitors (ACEi), and pregnancy

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Focus group cohort; Patients aged 18-100 with chronic cough including refractory chronic cough and unexplained chronic cough. Exclusions include: current smokers, ACE inhibitor use. Patients will be recruited to form focus groups to inform the creation of a cough control questionnaire. This will take the form of semi-structured interviews with open to closed questions. This same cohort will also engage in cognitive interviews after the preliminary cough control questionnaire has been made, to ensure that the language and wording is clear and appropriate. Recruitment will continue until thematic saturation is achieved.	Other: Focus group interviews; Semi-structured focus group interviews for patients with refractory chronic cough
Validation study cohort; Patients aged 18-100 with chronic cough will be recruited. Exclusion criteria include: current smokers, smoking within the last 12 months, use of angiotensin converting enzyme inhibitor (ACEi), respiratory tract infection within the last 4 weeks and limited English. Prospective consecutive patients with chronic cough will complete Cough Control Questionnaire, cough severity assessments and health status assessments. Patients will be invited to undergo objective cough frequency monitoring and cough challenge testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A questionnaire to assess cough control	The primary aim of the study is to develop and validate a cough control questionnaire which accurately reflects the nature of cough control.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough severity	Assessed using dedicated patient reported outcome measures. Correlations with CCQ will be assessed.	2 weeks
Cough-related quality of life and health status	Assessed using dedicated patient reported outcome measures. Correlations with CCQ will be assessed.	2 weeks
Cough frequency	Cough frequency (Coughs/24 hours) will be assessed at visits using cough monitors and correlations with CCQ will be assessed.	2 weeks
Cough reflex testing	Capsaicin concentration for C2 and C5 (to elicit 2, and 5 coughs respectively) will be assessed in a subset of patients. Correlations with CCQ will be assessed.	2 weeks

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2025
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031

Study Registration Dates

• First Submitted: April 1, 2025
• First Submitted That Met QC Criteria: April 1, 2025
• First Posted (Actual): April 9, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: control; patient-reported outcomes; questionnaire; cough
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: KCH24-072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: As the project progresses, other sites may be added. Only pseudonymised data would be sent to other researchers, for the purpose of statistical analysis and results.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No