Actively Recruiting

Age: 18Years - 100Years
All Genders
ID06918756

The Development and Validation of a Cough Control Questionnaire for Chronic Cough

Led by King's College Hospital NHS Trust · Updated on 2025-04-09

100

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are working to develop and validate a new patient-focused tool called the Cough Control Questionnaire (CCQ) to assess the control of chronic cough, a condition lasting more than 8 weeks that affects 5-12% of people worldwide and impacts health status and quality of life. Unlike asthma, there are currently no validated tools specifically designed to measure cough control. This study aims to create and test a questionnaire that may help evaluate treatments for chronic cough in clinical and research settings. The study consists of three phases. First, a literature review will examine existing tools for assessing respiratory disease control. Next, patient focus groups and expert panel reviews will develop the CCQ through qualitative research and cognitive interviews to ensure clarity and relevance. Finally, patients with chronic cough will complete the CCQ along with assessments of cough severity, quality of life, and health status. Some participants will also undergo objective cough frequency monitoring and cough reflex testing to validate the questionnaire. Participants will be adults aged 18 to 100 years with chronic cough, including refractory and unexplained types. They will take part in focus groups or validation studies by completing questionnaires and interviews. The study measures outcomes such as cough control via the CCQ, cough severity, quality of life, cough frequency, and reflex testing over a two-week period. This observational study is sponsored by King's College Hospital NHS Trust and runs until September 2031.

CONDITIONS

Brief Title

Development of a Cough Control Questionnaire (CCQ)

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 years and older
  • Have acute or chronic cough, including refractory or unexplained chronic cough
  • Able to read and write in English
  • A small group of healthy volunteers without significant respiratory disease may also be included
Not Eligible

You will not qualify if you...

  • Current smokers or those who have smoked within the last 12 months
  • Respiratory tract infection within the last 4 weeks
  • Use of angiotensin converting enzyme inhibitors (ACEi)
  • Pregnancy

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Focus Group Interviews

Duration - Until thematic saturation is achieved

Participants in the focus group cohort take part in semi-structured interviews to help develop the Cough Control Questionnaire and engage in cognitive interviews to ensure clarity of the questionnaire.

Multiple focus group sessions and cognitive interviews

Validation Study

Duration - Approximately 2 weeks

Participants in the validation study cohort complete the Cough Control Questionnaire, cough severity assessments, and health status assessments, and may undergo objective cough frequency monitoring and cough challenge testing.

1 to 2 visits depending on assessments

Trial Site Locations

Total: 1 location

1

King's College Hospital

London, United Kingdom, SE5 9RS

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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