Development of a Cough Control Questionnaire (CCQ)

NCT06918756 | Recruiting

• 1 other identifier: KCH24-072
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cough

Keywords

patient-reported outcomes; cough; control; questionnaire

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cough severity

  2 weeks

• Cough-related quality of life and health status

  2 weeks

• Cough frequency

  2 weeks

• Cough reflex testing

  2 weeks

Study Arms (2)

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

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.

Interventions

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

Focus group cohort

Objective cough measures OTHER

Cough monitoring and cough sensitivity testing.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients will be recruited from tertiary chronic cough clinics.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cough

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 9, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2031
• Last Updated: April 9, 2025

Record last verified: 2025-04

Locations

GB (1)