Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 8:29 AM
Study NCT ID:
NCT06674395
Status:
COMPLETED
Last Update Posted:
2025-01-03
First Post:
2024-11-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of Urdu Version of Leicester Cough Questionnaire (LCQ)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D003371', 'term': 'Cough'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-01', 'studyFirstSubmitDate': '2024-11-03', 'studyFirstSubmitQcDate': '2024-11-03', 'lastUpdatePostDateStruct': {'date': '2025-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leicester Cough Questionnaire (LCQ)', 'timeFrame': 'At Baseline and after 1 week', 'description': 'LCQ is a 19-item cough measuring tool, created in 2003 by Birring et al., and it comprised physical, psychological, and social elements.'}, {'measure': 'St. George Respiratory Questionnaire', 'timeFrame': 'At Baseline and after 1 week', 'description': 'Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cough', 'patient reported outcome measures', 'pulmonary diseases', 'validation study', 'translations'], 'conditions': ['COPD']}, 'referencesModule': {'references': [{'pmid': '18071022', 'type': 'BACKGROUND', 'citation': 'Polley L, Yaman N, Heaney L, Cardwell C, Murtagh E, Ramsey J, MacMahon J, Costello RW, McGarvey L. Impact of cough across different chronic respiratory diseases: comparison of two cough-specific health-related quality of life questionnaires. Chest. 2008 Aug;134(2):295-302. doi: 10.1378/chest.07-0141. Epub 2007 Dec 10.'}, {'pmid': '20051447', 'type': 'BACKGROUND', 'citation': 'Young EC, Smith JA. Quality of life in patients with chronic cough. Ther Adv Respir Dis. 2010 Feb;4(1):49-55. doi: 10.1177/1753465809358249. Epub 2010 Jan 5.'}, {'pmid': '31737324', 'type': 'BACKGROUND', 'citation': 'Wang Z, Wang M, Wen S, Yu L, Xu X. Types and applications of cough-related questionnaires. J Thorac Dis. 2019 Oct;11(10):4379-4388. doi: 10.21037/jtd.2019.09.62.'}, {'pmid': '12668799', 'type': 'BACKGROUND', 'citation': 'Birring SS, Prudon B, Carr AJ, Singh SJ, Morgan MD, Pavord ID. Development of a symptom specific health status measure for patients with chronic cough: Leicester Cough Questionnaire (LCQ). Thorax. 2003 Apr;58(4):339-43. doi: 10.1136/thorax.58.4.339.'}, {'pmid': '17313670', 'type': 'BACKGROUND', 'citation': 'Huisman AN, Wu MZ, Uil SM, van den Berg JW. Reliability and validity of a Dutch version of the Leicester Cough Questionnaire. Cough. 2007 Feb 21;3:3. doi: 10.1186/1745-9974-3-3.'}, {'pmid': '25517807', 'type': 'BACKGROUND', 'citation': 'Gao YH, Guan WJ, Xu G, Gao Y, Lin ZY, Tang Y, Lin ZM, Li HM, Luo Q, Zhong NS, Birring SS, Chen RC. Validation of the Mandarin Chinese version of the Leicester Cough Questionnaire in bronchiectasis. Int J Tuberc Lung Dis. 2014 Dec;18(12):1431-7. doi: 10.5588/ijtld.14.0195.'}, {'pmid': '28728439', 'type': 'BACKGROUND', 'citation': 'Sonnerfors P, Faager G, Einarsson U. Translation of the Leicester Cough Questionnaire into Swedish, and validity and reliability in chronic obstructive pulmonary disease. Disabil Rehabil. 2018 Nov;40(22):2662-2670. doi: 10.1080/09638288.2017.1353648. Epub 2017 Jul 20.'}, {'pmid': '27629838', 'type': 'BACKGROUND', 'citation': 'Dabrowska M, Krakowiak K, Radlinska O, Rybka A, Grabczak EM, Maskey-Warzechowska M, Korczynski P, Birring SS, Krenke R. Validation of the Polish Version of the Chronic Cough Quality of Life Questionnaire (Leicester Cough Questionnaire). Adv Clin Exp Med. 2016 Jul-Aug;25(4):649-53. doi: 10.17219/acem/59512.'}, {'pmid': '25749761', 'type': 'BACKGROUND', 'citation': 'Kwon JW, Moon JY, Kim SH, Song WJ, Kim MH, Kang MG, Lim KH, Lee SH, Lee SM, Lee JY, Kwon HS, Kim KM, Kim SH, Kim SH, Jeong JW, Kim CW, Cho SH, Lee BJ; Work Group for Chronic Cough, the Korean Academy of Asthma, Allergy and Clinical Immunology. Reliability and validity of a korean version of the leicester cough questionnaire. Allergy Asthma Immunol Res. 2015 May;7(3):230-3. doi: 10.4168/aair.2015.7.3.230. Epub 2014 Dec 18.'}, {'pmid': '26346891', 'type': 'BACKGROUND', 'citation': 'Reychler G, Schinckus M, Fremault A, Liistro G, Pieters T. Validation of the French version of the Leicester Cough Questionnaire in chronic obstructive pulmonary disease. Chron Respir Dis. 2015 Nov;12(4):313-9. doi: 10.1177/1479972315602618. Epub 2015 Sep 7.'}]}, 'descriptionModule': {'briefSummary': "Leicester Cough Questionnaire (LCQ) is a patient reported, 19-item tool, and it comprised physical, psychological, and social elements. The objective of the study is to cross culturally adapt LCQ in Urdu language and to find the reliability and validity in patients of COPD.\n\nIt is a three-stage study. Leicester Cough Questionnaire (LCQ) will be adapted in Urdu and will be first tested for its content validity by using content validity index (CVI).\n\nIn the second stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be pilot run; tested for its validity and reliability. In the third stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be tested for its validity and reliability in patients with COPD.\n\n114 Patients with COPD will be selected according to inclusion criteria. Intra class correlation coefficient (ICC), Cronbach's alpha and factor analysis will be used to analyze the data.", 'detailedDescription': "Cough is a common symptom of asthma, COPD, and bronchiectasis, little is known about how it affects health status; therefore any negative effects may go unnoticed in these situations. Leicester Cough Questionnaire (LCQ) is a patient reported, 19-item tool, and it comprised physical, psychological, and social elements. To the extent of author's knowledge, this widely used Leicester Cough Questionnaire (LCQ) has not been translated and validated for Urdu-speaking patients with COPD.\n\nThe objective of the study is to cross culturally adapt LCQ in Urdu language using international guidelines used for translation of instrument from its source language to target language and to find the reliability, validity, sensitivity, and specificity of the Urdu version of Leicester Cough Questionnaire (LCQ) in patients of COPD. It is a three-stage study.\n\nLeicester Cough Questionnaire (LCQ) will be adapted in Urdu and will be first tested for its content validity by using content validity index (CVI). In the second stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be pilot run; tested for its validity and reliability. In the third stage, the Urdu version of the Leicester Cough Questionnaire (LCQ) will be tested for its validity and reliability in patients with COPD. 114 Patients with COPD will be selected according to inclusion criteria. Intra class correlation coefficient (ICC), Cronbach's alpha and factor analysis will be used to analyze the data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with Chronic Obstructive Pulmonary Diseases', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with GOLD II, III and IV Chronic Obstructive Pulmonary Diseases\n* Having age18 years or more\n* subjects having chronic cough (\\> 8 weeks)\n* Subjects understanding Urdu\n\nExclusion Criteria:\n\n* A previous history of other lung disorders\n* Pregnant females, subjects having Infections\n* Any systemic disorder which is unstable\n* Subjects who are not willing to participate\n* subject with Cognitive \\& speech disorders'}, 'identificationModule': {'nctId': 'NCT06674395', 'briefTitle': 'Validation of Urdu Version of Leicester Cough Questionnaire (LCQ)', 'organization': {'class': 'OTHER', 'fullName': 'Riphah International University'}, 'officialTitle': 'Cross Cultural Validation of Urdu Version of Leicester Cough Questionnaire (LCQ)', 'orgStudyIdInfo': {'id': 'REC/RCR&AHS/24/0316'}}, 'contactsLocationsModule': {'locations': [{'city': 'Gujranwala', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Gujranwala Medical College Teaching Hospital', 'geoPoint': {'lat': 32.15567, 'lon': 74.18705}}], 'overallOfficials': [{'name': 'Wajeeha Zia, PhD*', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riphah International University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riphah International University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}