Development of a Cough Control Questionnaire (CCQ)
Research type
Research Study
Full title
Development of a Cough Control Questionnaire (CCQ).
IRAS ID
343049
Contact name
Peter Cho
Contact email
Sponsor organisation
King's College Hospital R&D department
Duration of Study in the UK
7 years, 0 months, 1 days
Research summary
The main purpose of the study is to create a new cough control questionnaire for patients with cough; control questionnaires have been successfully developed for other diseases such as asthma, but never in cough. Acute cough is one of the most common reasons for patients to see a medical professional and results in multiple lost working days. Chronic cough (>8 weeks in duration) affects 5-10% of the global population, and is a significant problem with associated considerable health status impairment and comorbidities. The management of chronic cough often involves sequential treatment trials, thus it is essential to be able to assess cough accurately. Currently, there are validated severity and impact outcome measures as well as objective measures (cough frequency monitoring) but this has not been shown to be useful in routine clinical practice. In addition, in light of the development of novel anti-tussive therapies, such as gefapixant, a validated cough control tool may facilitate studies of efficacy, and measure the therapeutic effect longitudinally.
Patients will be involved in the development of this questionnaire with semi-structured interviews in addition to an expert consensus meeting. Cognitive debriefing will be used to ensure that the preliminary questionnaire has accurate language and is clear to patients.
The main body of the study will involve the recruitment of 120 patients from King's College Hospital respiratory and cough clinics (aged 18-100), with and without chronic respiratory disease. These patients will have spirometry (lung function), cough monitoring and cough challenge testing performed at baseline. Patients will then have 2 further visits, completing our preliminary questionnaire with other recognised patient reported outcome measures to establish reliability and validity of the new control questionnaire. Cough monitoring and challenge testing will also be performed to assess responsiveness.
REC name
London - Bloomsbury Research Ethics Committee
REC reference
24/PR/1179
Date of REC Opinion
9 Oct 2024
REC opinion
Further Information Favourable Opinion