CoughCCQNCT06918756
Development of a Cough Control Questionnaire (CCQ)
An observational study of Cough, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Cough
- What is being tested?
- Questionnaires, Focus group interviews and Objective cough measures
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2025to 1 Sep 2031
- How long will I take part?
- 7 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients will be recruited from tertiary chronic cough clinics.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
King's College Hospital
London, SE5 9RS
Ewan Mackay, MBBS, BSc, MRCP, 02032999000 ext. 31096, ewan.mackay@nhs.net
Katie Rhatigan, MSc, 02032999000 ext. 31096, k.rhatigan@nhs.net
About this study
Official title: The Development and Validation of a Cough Control Questionnaire
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.
Read the detailed description
This study will involve 3 phases:
- Phase 1: Literature review. Review of currently available validated tools to assess control in respiratory diseases.
- Phase 2: Development of Cough Control Questionnaire (CCQ). Patient focus groups will aid development of a conceptual framework of cough control and ensure content validity through qualitative research methods including thematic analysis. Expert panel review of cough control framework will also be undertaken. CCQ item development will be grounded in patient focus groups and expert review findings, and reviewed through cognitive debrief with patients.
- Phase 3: Validation of CCQ. Prospective consecutive patients with chronic cough will complete CCQ, cough severity assessments and health status assessments. Patients will be invited to undergo objective cough frequency monitoring and cough challenge testing.
- Conditions
- Cough
- Being tested
- Questionnaires, Focus group interviews, Objective cough measures
- Keywords
- patient-reported outcomes, cough, control, questionnaire
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
Completion of new questionnaire in addition to other patient reported outcome measures that measure cough severity and cough-related quality of life.
Focus group interviewsOther
Semi-structured focus group interviews for patients with refractory chronic cough
Objective cough measuresOther
Cough monitoring and cough sensitivity testing.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Secondary outcomes (4)
Cough severity
Assessed using dedicated patient reported outcome measures. Correlations with CCQ will be assessed.
Measured: 2 weeks
Cough-related quality of life and health status
Assessed using dedicated patient reported outcome measures. Correlations with CCQ will be assessed.
Measured: 2 weeks
Cough frequency
Cough frequency (Coughs/24 hours) will be assessed at visits using cough monitors and correlations with CCQ will be assessed.
Measured: 2 weeks
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start1 Apr 2025
- Primary completion1 Sep 2031 (estimated)
- Study completion1 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918756
- Sponsor's protocol ID
- KCH24-072
- Acronym
- CCQ
- Status last verified
- Apr 2025
- First submitted
- 1 Apr 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: As the project progresses, other sites may be added. Only pseudonymised data would be sent to other researchers, for the purpose of statistical analysis and results.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Validation of a Cough Control Questionnaire
- ClinicalTrials.gov ID
- NCT06918756
- Acronym / sponsor ID
- CCQ / KCH24-072
- Conditions
- Cough
- Keywords
- patient-reported outcomes, cough, control, questionnaire
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 1 Sep 2031 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will involve 3 phases:
- Phase 1: Literature review. Review of currently available validated tools to assess control in respiratory diseases.
- Phase 2: Development of Cough Control Questionnaire (CCQ). Patient focus groups will aid development of a conceptual framework of cough control and ensure content validity through qualitative research methods including thematic analysis. Expert panel review of cough control framework will also be undertaken. CCQ item development will be grounded in patient focus groups and expert review findings, and reviewed through cognitive debrief with patients.
- Phase 3: Validation of CCQ. Prospective consecutive patients with chronic cough will complete CCQ, cough severity assessments and health status assessments. Patients will be invited to undergo objective cough frequency monitoring and cough challenge testing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Focus group cohort | – | Other: Focus group interviewsPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients will be recruited from tertiary chronic cough clinics.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesCompletion of new questionnaire in addition to other patient reported outcome measures that measure cough severity and cough-related quality of life. | Other | – |
| Focus group interviewsSemi-structured focus group interviews for patients with refractory chronic cough | Other | Focus group cohort |
| Objective cough measuresCough monitoring and cough sensitivity testing. | Other | – |
Primary outcome
A questionnaire to assess cough control
Time frame: 2 weeks
The primary aim of the study is to develop and validate a cough control questionnaire which accurately reflects the nature of cough control.
4 secondary outcomes
Cough severity
Time frame: 2 weeks
Cough-related quality of life and health status
Time frame: 2 weeks
Cough frequency
Time frame: 2 weeks
Cough reflex testing
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: Undecided. As the project progresses, other sites may be added. Only pseudonymised data would be sent to other researchers, for the purpose of statistical analysis and results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A questionnaire to assess cough control (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.