Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-25 @ 9:17 PM
Study NCT ID:
NCT06918756
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of a Cough Control Questionnaire (CCQ)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003371', 'term': 'Cough'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '7 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2031-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2025-04-01', 'studyFirstSubmitQcDate': '2025-04-01', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'A questionnaire to assess cough control', 'timeFrame': '2 weeks', 'description': 'The primary aim of the study is to develop and validate a cough control questionnaire which accurately reflects the nature of cough control.'}], 'secondaryOutcomes': [{'measure': 'Cough severity', 'timeFrame': '2 weeks', 'description': 'Assessed using dedicated patient reported outcome measures. Correlations with CCQ will be assessed.'}, {'measure': 'Cough-related quality of life and health status', 'timeFrame': '2 weeks', 'description': 'Assessed using dedicated patient reported outcome measures. Correlations with CCQ will be assessed.'}, {'measure': 'Cough frequency', 'timeFrame': '2 weeks', 'description': 'Cough frequency (Coughs/24 hours) will be assessed at visits using cough monitors and correlations with CCQ will be assessed.'}, {'measure': 'Cough reflex testing', 'timeFrame': '2 weeks', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['patient-reported outcomes', 'cough', 'control', 'questionnaire'], 'conditions': ['Cough']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': 'This study will involve 3 phases:\n\n* Phase 1: Literature review. Review of currently available validated tools to assess control in respiratory diseases.\n* 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.\n* 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': False, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients will be recruited from tertiary chronic cough clinics.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT06918756', 'acronym': 'CCQ', 'briefTitle': 'Development of a Cough Control Questionnaire (CCQ)', 'organization': {'class': 'OTHER', 'fullName': "King's College Hospital NHS Trust"}, 'officialTitle': 'The Development and Validation of a Cough Control Questionnaire', 'orgStudyIdInfo': {'id': 'KCH24-072'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Focus group cohort', 'description': '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.', 'interventionNames': ['Other: Focus group interviews']}, {'label': 'Validation study cohort', 'description': '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.\n\nProspective 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': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'Completion of new questionnaire in addition to other patient reported outcome measures that measure cough severity and cough-related quality of life.'}, {'name': 'Focus group interviews', 'type': 'OTHER', 'description': 'Semi-structured focus group interviews for patients with refractory chronic cough', 'armGroupLabels': ['Focus group cohort']}, {'name': 'Objective cough measures', 'type': 'OTHER', 'description': 'Cough monitoring and cough sensitivity testing.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE5 9RS', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Ewan Mackay, MBBS, BSc, MRCP', 'role': 'CONTACT', 'email': 'ewan.mackay@nhs.net', 'phone': '02032999000', 'phoneExt': '31096'}, {'name': 'Katie Rhatigan, MSc', 'role': 'CONTACT', 'email': 'k.rhatigan@nhs.net', 'phone': '02032999000', 'phoneExt': '31096'}, {'name': 'Surinder Birring, MB ChB, BSc, MD, MRCP', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ewan Mackay, MBBS, BSc, MRCP', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Peter Cho, MBBS, PhD, MRCP', 'role': 'SUB_INVESTIGATOR'}], 'facility': "King's College Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College Hospital NHS Trust", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}