Health TrialsbyHealthPanel

Development of a Cough Control Questionnaire (CCQ)

ConditionCough
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorKing's College Hospital NHS Trust

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial population

Consecutive patients will be recruited from tertiary chronic cough clinics.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Questionnaires

    Other intervention

    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 intervention

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

  • Objective cough measures

    Other intervention

    Cough monitoring and cough sensitivity testing.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Focus group cohort1 intervention
Group B: Validation study cohort0 interventions

Trial outcomes

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.

Time frame
2 weeks

Secondary outcomes

1

Cough severity

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

Time frame
2 weeks
2

Cough-related quality of life and health status

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

Time frame
2 weeks
3

Cough frequency

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

Time frame
2 weeks
4

Cough reflex testing

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.

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King's College Hospital NHS Trust

Lead sponsor

Source ClinicalTrials.gov
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