The Development and Validation of a Cough Control Questionnaire

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
United Kingdom
King's College Hospital
RECRUITING
London
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2031-09-01
Participants
Target number of participants: 100
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: King's College Hospital NHS Trust

This content was sourced from clinicaltrials.gov