Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT00328718
Status:
COMPLETED
Last Update Posted:
2017-01-20
First Post:
2006-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Ecuador']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C093875', 'term': 'montelukast'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'C494814', 'term': 'BID protein, human'}], 'ancestors': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 526}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2006-05-19', 'studyFirstSubmitQcDate': '2006-05-19', 'lastUpdatePostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline to endpoint of:morning pre-dose FEV1 (Forced expiratory volume) symptom free 24 hour-periods rescue medication-free 24 hour-periods mean evening PEFR'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Persistent Asthma', 'pediatric asthmatic', 'asthma control'], 'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '18803991', 'type': 'BACKGROUND', 'citation': 'Maspero J, Guerra F, Cuevas F, Gutierrez JP, Soto-Ramos M, Anderton S, Mechali D, Chan R, Pedersen S. Efficacy and tolerability of salmeterol/fluticasone propionate versus montelukast in childhood asthma: A prospective, randomized, double-blind, double-dummy, parallel-group study. Clin Ther. 2008 Aug;30(8):1492-504. doi: 10.1016/j.clinthera.2008.07.018.'}]}, 'descriptionModule': {'briefSummary': "This study is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment \\[Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)\\] on lung function, asthma control, Health Outcomes including the child's quality of life as measured by Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver's quality of life as measured by Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) at selected centers where a valid translation is available.", 'detailedDescription': 'Pediatric Asthma Clinical Effectiveness study (PEACE). A Randomized, Double-Blind, Double Dummy, Parallel Group comparative clinical study of Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) via DISKUS† with Oral montelukast (5mg QD) Chewable Tablets in Children 6-14 years of Age with Persistent Asthma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Diagnosis of asthma for at least 6 months (per American Thoracic Society \\[ATS\\] definition).\n* Best forced expiratory volume in one second (FEV1) between 55% and 80% of predicted normal.\n* More than or 12% FEV1 reversibility following inhalation of salbutamol.\n* Must also be symptomatic on short-acting beta-agonists.\n* Must not have used inhaled corticosteroids over the previous month or LTRAs (Leukotriene antagonists)over the previous 2 weeks.\n\nExclusion criteria:\n\n* Hospital admission for asthma within 3 months prior to Visit 1.\n* Sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within two weeks immediately preceding Screening Visit 1.\n* Oral or parenteral steroid therapy in the last 12 weeks, or more than 3 courses in the last 6 months.'}, 'identificationModule': {'nctId': 'NCT00328718', 'briefTitle': 'Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets', 'organization': {'class': 'INDUSTRY', 'fullName': 'GlaxoSmithKline'}, 'officialTitle': 'Randomised, Double-blind, Double-dummy, Parallel-group, Comparative Study of Salmeterol/FP 50/100mcg bd Inhalation Powder Via Diskus With Oral Montelukast (5mg QD) Chewable Tablets in Children 6-14 Years', 'orgStudyIdInfo': {'id': 'SAM103848'}}, 'armsInterventionsModule': {'interventions': [{'name': 'montelukast (5mg QD)', 'type': 'DRUG'}, {'name': 'Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)', 'type': 'DRUG', 'otherNames': ['montelukast (5mg QD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Santa Fe', 'state': 'Santa Fe Province', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -31.64881, 'lon': -60.70868}}, {'zip': 'C1121ABE', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1424BSF', 'city': 'Capital Federal-Buenos Aires', 'country': 'Argentina', 'facility': 'GSK Investigational Site'}, {'zip': '11001000', 'city': 'Bogotá', 'country': 'Colombia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}, {'zip': '76001000', 'city': 'Cali', 'country': 'Colombia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 3.43054, 'lon': -76.5199}}, {'zip': '05001000', 'city': 'Medellín', 'country': 'Colombia', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}, {'city': 'San José', 'country': 'Costa Rica', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 9.93388, 'lon': -84.08489}}, {'zip': '31020', 'city': 'Chihuahua City', 'state': 'Chihuahua', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 28.63528, 'lon': -106.08889}}, {'zip': '44340', 'city': 'Guadalajara', 'state': 'Jalisco', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 20.67738, 'lon': -103.34749}}, {'zip': '64460', 'city': 'Monterrey', 'state': 'Nuevo León', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 25.68435, 'lon': -100.31721}}, {'zip': '03020', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '14080', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '04530', 'city': 'México', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': '6720', 'city': 'México', 'country': 'Mexico', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 31.00435, 'lon': -108.15213}}, {'zip': 'Lima 1', 'city': 'Lima', 'state': 'Lima Province', 'country': 'Peru', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': 'Lima 27', 'city': 'Lima', 'state': 'Lima Province', 'country': 'Peru', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '1330', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}, {'zip': '6100', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'zip': '7070', 'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}, {'zip': '16059', 'city': 'Bursa', 'country': 'Turkey (Türkiye)', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 40.19559, 'lon': 29.06013}}, {'zip': '34303', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '34668', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'zip': '35100', 'city': 'Izmir', 'country': 'Turkey (Türkiye)', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}, {'zip': '1010', 'city': 'Caracas', 'country': 'Venezuela', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}, {'zip': '1060', 'city': 'Caracas', 'country': 'Venezuela', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}, {'zip': '1080', 'city': 'Caracas', 'country': 'Venezuela', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 10.48801, 'lon': -66.87919}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GlaxoSmithKline'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}