Ignite Creation Date:
2025-12-24 @ 2:58 PM
Ignite Modification Date:
2026-02-28 @ 8:10 AM
Study NCT ID:
NCT05642559
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2022-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study for the Development and Validation of Chronic Cough Patient Perspective Questionnaire
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000096822', 'term': 'Chronic Cough'}], 'ancestors': [{'id': 'D003371', 'term': 'Cough'}, {'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': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-14', 'studyFirstSubmitDate': '2022-11-10', 'studyFirstSubmitQcDate': '2022-12-07', 'lastUpdatePostDateStruct': {'date': '2024-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chronic Cough Impact Questionnaire (CCIQ)', 'timeFrame': 'february 2023', 'description': 'To develop the preliminary CCPP questionnaire starting from Chronic Cough Impact Questionnaire (CCIQ) (2) and available database'}], 'secondaryOutcomes': [{'measure': 'Chronic Cough Impact Questionnaire (CCIQ)', 'timeFrame': 'August 2023', 'description': 'Assessment of refractory chronic cough (RCC) or unexplained chronic cough impact on HRQoL of the explored population and relationship with clinical variables'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Cough']}, 'descriptionModule': {'briefSummary': "Starting from Chronic Cough Impact Querstionnaire (CCIQ), of which we are the authors and copyright holders, it will be developed and validated a shortened version with psychometric properties allowing the use in the evaluation of single patient (Chronic Cough Patient Perspective).\n\nThe CCPP will allow to unmask the problem, reduce underdiagnosis, increase awareness on chronic cough, measure the impact of the chronic cough and its treatments on the patient's life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients (\\>18 years) suffering from RCC (Residual Cough VAS:\\>10/100 mm)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\ndiagnosis of RCC (Residual Cough VAS:\\>10/100 mm) according to ERS guidelines\n\nExclusion Criteria:\n\ndifficulty in understanding the italian language in both spoken and written form'}, 'identificationModule': {'nctId': 'NCT05642559', 'acronym': 'MISP', 'briefTitle': 'Study for the Development and Validation of Chronic Cough Patient Perspective Questionnaire', 'organization': {'class': 'OTHER', 'fullName': 'Ospedale Policlinico San Martino'}, 'officialTitle': 'Retrospective and Prospective Observational Study for the Development and Validation of Chronic Cough Patient Perspective Questionnaire', 'orgStudyIdInfo': {'id': '22/2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'questionnaire', 'type': 'OTHER', 'description': 'Assessment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) impact on HRQoL of the explored population and relationship with clinical variables. Development of a web application of the questionnaire.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16132', 'city': 'Genova', 'country': 'Italy', 'facility': 'IRCCS San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ospedale Policlinico San Martino', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'BRAIDO', 'investigatorAffiliation': 'Ospedale Policlinico San Martino'}}}}