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NCT Number: NCT06918756

Development of a Cough Control Questionnaire (CCQ)

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

King's College Hospital

London, SE5 9RS, United Kingdom

Location status: Recruiting

Location contact

Ewan Mackay, MBBS, BSc, MRCP

CONTACT

[email protected]

02032999000 ext. 31096

Ewan Mackay, MBBS, BSc, MRCP

SUB_INVESTIGATOR

Katie Rhatigan, MSc

CONTACT

[email protected]

02032999000 ext. 31096

Peter Cho, MBBS, PhD, MRCP

SUB_INVESTIGATOR

Surinder Birring, MB ChB, BSc, MD, MRCP

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

Completion of new questionnaire in addition to other patient reported outcome measures that measure cough severity and cough-related quality of life.

Focus Group Interviews

Other

Semi-structured focus group interviews for patients with refractory chronic cough

Objective cough measures

Other

Cough monitoring and cough sensitivity testing.

Primary outcomes

  1. A questionnaire to assess cough control

    Time frame: 2 weeks

    The primary aim of the study is to develop and validate a cough control questionnaire which accurately reflects the nature of cough control.

Secondary outcomes

  1. Cough severity

    Time frame: 2 weeks

    Assessed using dedicated patient reported outcome measures. Correlations with CCQ will be assessed.

  2. Cough-related quality of life and health status

    Time frame: 2 weeks

    Assessed using dedicated patient reported outcome measures. Correlations with CCQ will be assessed.

  3. Cough frequency

    Time frame: 2 weeks

    Cough frequency (Coughs/24 hours) will be assessed at visits using cough monitors and correlations with CCQ will be assessed.

  4. Cough reflex testing

    Time frame: 2 weeks

    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.

Sponsors and collaborators

Lead sponsor

King's College Hospital NHS Trust

Other

Registry information

Official study title

The Development and Validation of a Cough Control Questionnaire

Acronym: CCQ

Important dates

Study start
2025
Primary completion
2031
Study completion
2031
First posted
Apr 9, 2025
Registry last updated
Apr 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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