A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma

details{'conditions': ['Asthma'], 'countries': ['Australia', 'Canada', 'Chile', 'Costa Rica', 'Germany', 'Latvia', 'Lithuania', 'Mexico', 'Peru', 'Poland', 'Russia', 'Spain', 'United States'], 'interventions': [{'name': 'fluticasone propionate', 'type': 'DRUG', 'description': 'fluticasone propionate 100mcg HFA'}, {'name': 'fluticasone propionate/salmeterol', 'type': 'DRUG', 'description': 'fluticasone propionate/salmeterol 100/50mcg HFA'}], 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '92647', 'city': 'Huntington Beach', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '90806', 'city': 'Long Beach', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '90808', 'city': 'Long Beach', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92506', 'city': 'Riverside', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '80206', 'city': 'Denver', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '80401', 'city': 'Lakewood', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '32207', 'city': 'Jacksonville', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '30501', 'city': 'Gainesville', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '48197', 'city': 'Ypsilanti', 'name': 'GSK Investigational Site', 'state': 'Michigan', 'country': 'United States'}, {'zip': '14850', 'city': 'Cortland', 'name': 'GSK Investigational Site', 'state': 'New York', 'country': 'United States'}, {'zip': '27607', 'city': 'Raleigh', 'name': 'GSK Investigational Site', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '44718', 'city': 'Canton', 'name': 'GSK Investigational Site', 'state': 'Ohio', 'country': 'United States'}, {'zip': '73120', 'city': 'Oklahoma City', 'name': 'GSK Investigational Site', 'state': 'Oklahoma', 'country': 'United States'}, {'zip': '97035', 'city': 'Lake Oswego', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '97504', 'city': 'Medford', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '97213', 'city': 'Portland', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '15241', 'city': 'Pittsburgh', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '29407', 'city': 'Charleston', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '38138', 'city': 'Germantown', 'name': 'GSK Investigational Site', 'state': 'Tennessee', 'country': 'United States'}, {'zip': '05403', 'city': 'South Burlington', 'name': 'GSK Investigational Site', 'state': 'Vermont', 'country': 'United States'}, {'zip': '3168', 'city': 'Clayton', 'name': 'GSK Investigational Site', 'state': 'Victoria', 'country': 'Australia'}, {'zip': '3052', 'city': 'Parkville', 'name': 'GSK Investigational Site', 'state': 'Victoria', 'country': 'Australia'}, {'zip': '6001', 'city': 'Subiaco', 'name': 'GSK Investigational Site', 'state': 'Western Australia', 'country': 'Australia'}, {'zip': 'A1E 2C2', 'city': "St. John's", 'name': 'GSK Investigational Site', 'state': 'Newfoundland and Labrador', 'country': 'Canada'}, {'zip': 'L6T 3T1', 'city': 'Brampton', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'L5A 3V4', 'city': 'Mississauga', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'N7T 4X3', 'city': 'Sarnia', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': None, 'city': 'Santiago', 'name': 'GSK Investigational Site', 'state': 'Región Metro de Santiago', 'country': 'Chile'}, {'zip': None, 'city': 'Viña del Mar', 'name': 'GSK Investigational Site', 'state': 'Valparaiso', 'country': 'Chile'}, {'zip': '8360156', 'city': 'Santiago', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Chile'}, {'zip': None, 'city': 'San José', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Costa Rica'}, {'zip': '44791', 'city': 'Bochum', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '33332', 'city': 'Gütersloh', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '47533', 'city': 'Kleve-Materborn', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '46483', 'city': 'Wesel', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '55131', 'city': 'Mainz', 'name': 'GSK Investigational Site', 'state': 'Rhineland-Palatinate', 'country': 'Germany'}, {'zip': '21502', 'city': 'Geesthacht', 'name': 'GSK Investigational Site', 'state': 'Schleswig-Holstein', 'country': 'Germany'}, {'zip': 'LV5001', 'city': 'Ogre', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': 'LV1050', 'city': 'Riga', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': 'LT-50009', 'city': 'Kaunas', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Lithuania'}, {'zip': 'LT-28151', 'city': 'Utena', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Lithuania'}, {'zip': 'LT-01117', 'city': 'Vilnius', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Lithuania'}, {'zip': '31020', 'city': 'Chihuahua City', 'name': 'GSK Investigational Site', 'state': 'Chihuahua', 'country': 'Mexico'}, {'zip': '64988', 'city': 'Monterrey N.L', 'name': 'GSK Investigational Site', 'state': 'Nuevo León', 'country': 'Mexico'}, {'zip': '04530', 'city': 'Mexico City', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Mexico'}, {'zip': '6720', 'city': 'México', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Mexico'}, {'zip': 'Lima 27', 'city': 'Lima', 'name': 'GSK Investigational Site', 'state': 'Lima Province', 'country': 'Peru'}, {'zip': '90-329', 'city': 'Lodz', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '34-700', 'city': 'Rabka-Zdrój', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '119435', 'city': 'Moscow', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '630099', 'city': 'Novosibirsk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '191144', 'city': "St'Petersburg", 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '634 050', 'city': 'Tomsk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '30120', 'city': 'Murcia', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '30720', 'city': 'San Javier (Murcia)', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Possible Drug-Related Adverse Events', 'time_frame': 'Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug)', 'description': 'Adverse Events reported by the Investigator and judged by the Investigator to be possibly related to study drug, categorized by the Medical Dictionary for Regulatory Activities (MeDRA), were reported. ECG, electrocardiogram. QTc (corrected QT interval) and QT represent intervals on an ECG.'}, {'type': 'PRIMARY', 'title': 'Investigator Evaluations of Electrocardiogram (ECG) Results', 'time_frame': 'Baseline and Week 12', 'description': "ECGs were transmitted to an independent cardiologist who was responsible for providing interpretation of the ECG as either normal or abnormal (based on personal assessment). The investigator was then responsible for determining the clinical significance of the abnormal ECG in the context of the participants' history and clinical presentation. An abnormal, clinically significant ECG included, but was not limited to: prolonged QT interval, ischemic changes, ventricular hypertrophy, intraventricular conduction abnormalities, and clinically significant arrhythmias. PD, premature discontinuation."}, {'type': 'PRIMARY', 'title': 'Clinically Significant Unfavorable ECGs at Week 12', 'time_frame': 'Baseline, Week 12', 'description': 'Post-randomization ECGs categorized by the primary investigator as no change, significant change (favorable), significant change (unfavorable) from the ECG performed at Visit 1 (Baseline) are presented. Significant change (favorable) includes any ECG that improved from baseline, whereas significant change (unfavorable) includes any ECG that worsened from baseline. Clinical significance is determined by the primary investigator.'}, {'type': 'PRIMARY', 'title': 'ECG Measures - Heart Rate', 'time_frame': 'Baseline and Week 12', 'description': 'The range of heart rates for this study was between 49-144 beats per minute'}, {'type': 'PRIMARY', 'title': 'ECG Measures - QT Interval', 'time_frame': 'Baseline and Week 12', 'description': "Fridericia's formula QTc interval=QT interval/cubed root of the R-R interval. The Bazett's formula QTc=QT/squared root of the R-R interval."}, {'type': 'PRIMARY', 'title': 'Cardiovascular Adverse Events Reported During Treatment Period', 'time_frame': '12-Week Treatment Period', 'description': 'Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Treatment Period. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event. Please see the category titles for a list of candidate cardiovascular adverse events.'}, {'type': 'PRIMARY', 'title': 'Cardiovascular Adverse Events Reported During the Post-Treatment Period', 'time_frame': '5 Days after Week 12', 'description': 'Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Post-treatment period, defined as 1 day after last dose of study drug. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event.'}, {'type': 'PRIMARY', 'title': 'Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols', 'time_frame': 'Treatment period (weeks 1-12)', 'description': "The Primary Investigator determined the severity of the exacerbation based on the participant's clinical presentation and the investigator's understanding of the disease, the participant, and his or her clinical experiences. The severity of the exacerbation was not defined in the protocol. Mild: Usually treated at home. Prompt relief with inhaled short-acting beta2 agonist. Possible short course of oral systemic corticosteroids. Moderate: Usually requires office or emergency department visit. Relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for 1-2 days after treatment begins. Severe: Usually requires emergency department visit and likely hospitalization. Partial relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for more than 3 days after treatment begins. Adjunctive therapies are helpful."}, {'type': 'PRIMARY', 'title': 'Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion', 'time_frame': 'Baseline and week 12', 'description': '"Abnormal high cortisol excretion" and "Abnormal low cortisol excretion" are defined as above the upper limit of normal and below the lower limit of normal, respectively. The normal range for cortisol levels vary by age and gender. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12', 'time_frame': 'Baseline and Week 12', 'description': 'Normal range for Cortisol levels vary by age and gender. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion', 'time_frame': 'Baseline and Week 12', 'description': 'Normal range for Cortisol levels vary by age and gender. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use', 'time_frame': 'Baseline and Week 12', 'description': 'AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. "Abnormal high cortisol excretion" and "Abnormal low cortisol excretion" are defined as above the upper limit of normal and below the lower limit of normal, respectively. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12', 'time_frame': 'Baseline and Week 12', 'description': 'AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use', 'time_frame': 'Baseline and Week 12', 'description': 'AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).'}, {'type': 'SECONDARY', 'title': 'Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years', 'time_frame': 'Baseline and week 12', 'description': 'FEV1 (Forced Expiratory Volume in 1 second) is the volume of air that can be forced out in one second, after taking a deep breath. FEV1 is measured using a spirometer and obtaining "best effort" from 3 to 8 measurements. Week 12 is the measure taken at Week 12.'}, {'type': 'SECONDARY', 'title': 'AM Peak Expiratory Flow', 'time_frame': 'Baseline and 12-Week Treatment Period', 'description': 'The peak expiratory flow (PEF) rate measures how fast a person can exhale air. It is used to compare to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 inches is 147 Liters/minute (L/min), whose height is 66 inches is 454 L/min. Triplicate measurements taken for the best effort recorded.'}, {'type': 'SECONDARY', 'title': 'Asthma Symptom Scores', 'time_frame': 'Baseline and 12-Week Treatment Period', 'description': 'Each morning prior dosing or PEF, self-scored based on past 24 hours: 0=No symptoms, 1=Symptoms for one short period, 2=Symptoms for two or more short periods, 3=Frequent Symptoms which did not affect activities of daily living (ADL), 4=Frequent.'}, {'type': 'SECONDARY', 'title': 'Percentage of Symptom Free Days', 'time_frame': 'Baseline and 12-Week Treatment Period', 'description': 'Percentage of number of days without asthma symptoms based on Asthma Symptom Scores. Each morning prior to dosing or PEF, asthma symptoms were self-scored based on the past 24 hours: 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=frequent symptoms that did not affect activities of daily living (ADL), 4=frequent .'}, {'type': 'SECONDARY', 'title': 'Albuterol Use', 'time_frame': 'Baseline and 12-Week Treatment Period', 'description': 'Albuterol inhalation aerosol was used as a rescue or prophylactic and recorded daily by subject or caregiver. The number of puffs of albuterol over the previous 24 hour period prior to dosing was recorded.'}, {'type': 'SECONDARY', 'title': 'Percent of Albuterol-free Days', 'time_frame': 'Baseline and 12-Week Treatment Period', 'description': 'Percentage of days when Albuterol use was unnecessary based on daily record and symptom free days.'}, {'type': 'POST_HOC', 'title': 'Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12', 'time_frame': 'Baseline and Week 12', 'description': 'A post-hoc analysis excluding participants with urine cortisol baseline values of \\>200 nanomoles/24 hours. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.'}, {'type': 'POST_HOC', 'title': 'Geometric Mean Ratio for Baseline:Week12 24-hour Urinary Cortisol Excretion', 'time_frame': 'Baseline and Week 12', 'description': 'A post-hoc analysis excluding participants with urine cortisol baseline values of \\>200 nmol/24 hrs. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs) .'}, {'type': 'POST_HOC', 'title': 'Geometric Mean Values of 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population at Baseline and Week 12', 'time_frame': 'Baseline and Week 12', 'description': 'AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.'}, {'type': 'POST_HOC', 'title': 'Geometric Mean Ratio for Baseline: Week 12 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population', 'time_frame': 'Baseline and Week 12', 'description': 'AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value,nanomoles per 24 hours (nmol/24 hrs) .'}], 'brief_summary': 'This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2010-09-23', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['Australia', 'Canada', 'Chile', 'Costa Rica', 'Germany', 'Latvia', 'Lithuania', 'Mexico', 'Peru', 'Poland', 'Russia', 'Spain', 'United States'], 'interventions': [{'name': 'fluticasone propionate', 'type': 'DRUG', 'description': 'fluticasone propionate 100mcg HFA', 'other_names': [], 'design_groups': [{'id': 421536424, 'type': 'EXPERIMENTAL', 'title': 'Fluticasone propionate 100mcg HFA', 'description': 'Fluticasone propionate 100mcg HFA (2 inhalations of 50mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate/salmeterol 100/50 HFA inhaler (2 inhalations ) twice daily'}]}, {'name': 'fluticasone propionate/salmeterol', 'type': 'DRUG', 'description': 'fluticasone propionate/salmeterol 100/50mcg HFA', 'other_names': [], 'design_groups': [{'id': 421536423, 'type': 'EXPERIMENTAL', 'title': 'Fluticasone propionate/salmeterol 100/50 HFA', 'description': 'Fluticasone propionate/salmeterol 100/50 HFA (2 inhalations of 50/25mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate 100mcg HFA inhaler (2 inhalations) twice daily'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '92647', 'city': 'Huntington Beach', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '90806', 'city': 'Long Beach', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '90808', 'city': 'Long Beach', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '92506', 'city': 'Riverside', 'name': 'GSK Investigational Site', 'state': 'California', 'country': 'United States'}, {'zip': '80206', 'city': 'Denver', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '80401', 'city': 'Lakewood', 'name': 'GSK Investigational Site', 'state': 'Colorado', 'country': 'United States'}, {'zip': '32207', 'city': 'Jacksonville', 'name': 'GSK Investigational Site', 'state': 'Florida', 'country': 'United States'}, {'zip': '30501', 'city': 'Gainesville', 'name': 'GSK Investigational Site', 'state': 'Georgia', 'country': 'United States'}, {'zip': '48197', 'city': 'Ypsilanti', 'name': 'GSK Investigational Site', 'state': 'Michigan', 'country': 'United States'}, {'zip': '14850', 'city': 'Cortland', 'name': 'GSK Investigational Site', 'state': 'New York', 'country': 'United States'}, {'zip': '27607', 'city': 'Raleigh', 'name': 'GSK Investigational Site', 'state': 'North Carolina', 'country': 'United States'}, {'zip': '44718', 'city': 'Canton', 'name': 'GSK Investigational Site', 'state': 'Ohio', 'country': 'United States'}, {'zip': '73120', 'city': 'Oklahoma City', 'name': 'GSK Investigational Site', 'state': 'Oklahoma', 'country': 'United States'}, {'zip': '97035', 'city': 'Lake Oswego', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '97504', 'city': 'Medford', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '97213', 'city': 'Portland', 'name': 'GSK Investigational Site', 'state': 'Oregon', 'country': 'United States'}, {'zip': '15241', 'city': 'Pittsburgh', 'name': 'GSK Investigational Site', 'state': 'Pennsylvania', 'country': 'United States'}, {'zip': '29407', 'city': 'Charleston', 'name': 'GSK Investigational Site', 'state': 'South Carolina', 'country': 'United States'}, {'zip': '38138', 'city': 'Germantown', 'name': 'GSK Investigational Site', 'state': 'Tennessee', 'country': 'United States'}, {'zip': '05403', 'city': 'South Burlington', 'name': 'GSK Investigational Site', 'state': 'Vermont', 'country': 'United States'}, {'zip': '3168', 'city': 'Clayton', 'name': 'GSK Investigational Site', 'state': 'Victoria', 'country': 'Australia'}, {'zip': '3052', 'city': 'Parkville', 'name': 'GSK Investigational Site', 'state': 'Victoria', 'country': 'Australia'}, {'zip': '6001', 'city': 'Subiaco', 'name': 'GSK Investigational Site', 'state': 'Western Australia', 'country': 'Australia'}, {'zip': 'A1E 2C2', 'city': "St. John's", 'name': 'GSK Investigational Site', 'state': 'Newfoundland and Labrador', 'country': 'Canada'}, {'zip': 'L6T 3T1', 'city': 'Brampton', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'L5A 3V4', 'city': 'Mississauga', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': 'N7T 4X3', 'city': 'Sarnia', 'name': 'GSK Investigational Site', 'state': 'Ontario', 'country': 'Canada'}, {'zip': None, 'city': 'Santiago', 'name': 'GSK Investigational Site', 'state': 'Región Metro de Santiago', 'country': 'Chile'}, {'zip': None, 'city': 'Viña del Mar', 'name': 'GSK Investigational Site', 'state': 'Valparaiso', 'country': 'Chile'}, {'zip': '8360156', 'city': 'Santiago', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Chile'}, {'zip': None, 'city': 'San José', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Costa Rica'}, {'zip': '44791', 'city': 'Bochum', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '33332', 'city': 'Gütersloh', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '47533', 'city': 'Kleve-Materborn', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '46483', 'city': 'Wesel', 'name': 'GSK Investigational Site', 'state': 'North Rhine-Westphalia', 'country': 'Germany'}, {'zip': '55131', 'city': 'Mainz', 'name': 'GSK Investigational Site', 'state': 'Rhineland-Palatinate', 'country': 'Germany'}, {'zip': '21502', 'city': 'Geesthacht', 'name': 'GSK Investigational Site', 'state': 'Schleswig-Holstein', 'country': 'Germany'}, {'zip': 'LV5001', 'city': 'Ogre', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': 'LV1050', 'city': 'Riga', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Latvia'}, {'zip': 'LT-50009', 'city': 'Kaunas', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Lithuania'}, {'zip': 'LT-28151', 'city': 'Utena', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Lithuania'}, {'zip': 'LT-01117', 'city': 'Vilnius', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Lithuania'}, {'zip': '31020', 'city': 'Chihuahua City', 'name': 'GSK Investigational Site', 'state': 'Chihuahua', 'country': 'Mexico'}, {'zip': '64988', 'city': 'Monterrey N.L', 'name': 'GSK Investigational Site', 'state': 'Nuevo León', 'country': 'Mexico'}, {'zip': '04530', 'city': 'Mexico City', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Mexico'}, {'zip': '6720', 'city': 'México', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Mexico'}, {'zip': 'Lima 27', 'city': 'Lima', 'name': 'GSK Investigational Site', 'state': 'Lima Province', 'country': 'Peru'}, {'zip': '90-329', 'city': 'Lodz', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '34-700', 'city': 'Rabka-Zdrój', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Poland'}, {'zip': '119435', 'city': 'Moscow', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '630099', 'city': 'Novosibirsk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '191144', 'city': "St'Petersburg", 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '634 050', 'city': 'Tomsk', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Russia'}, {'zip': '30120', 'city': 'Murcia', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}, {'zip': '30720', 'city': 'San Javier (Murcia)', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Spain'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Possible Drug-Related Adverse Events', 'time_frame': 'Treatment period (weeks 1-12) and Post Treatment (≥1 day after last time study drug)', 'description': 'Adverse Events reported by the Investigator and judged by the Investigator to be possibly related to study drug, categorized by the Medical Dictionary for Regulatory Activities (MeDRA), were reported. ECG, electrocardiogram. QTc (corrected QT interval) and QT represent intervals on an ECG.'}, {'type': 'PRIMARY', 'title': 'Investigator Evaluations of Electrocardiogram (ECG) Results', 'time_frame': 'Baseline and Week 12', 'description': "ECGs were transmitted to an independent cardiologist who was responsible for providing interpretation of the ECG as either normal or abnormal (based on personal assessment). The investigator was then responsible for determining the clinical significance of the abnormal ECG in the context of the participants' history and clinical presentation. An abnormal, clinically significant ECG included, but was not limited to: prolonged QT interval, ischemic changes, ventricular hypertrophy, intraventricular conduction abnormalities, and clinically significant arrhythmias. PD, premature discontinuation."}, {'type': 'PRIMARY', 'title': 'Clinically Significant Unfavorable ECGs at Week 12', 'time_frame': 'Baseline, Week 12', 'description': 'Post-randomization ECGs categorized by the primary investigator as no change, significant change (favorable), significant change (unfavorable) from the ECG performed at Visit 1 (Baseline) are presented. Significant change (favorable) includes any ECG that improved from baseline, whereas significant change (unfavorable) includes any ECG that worsened from baseline. Clinical significance is determined by the primary investigator.'}, {'type': 'PRIMARY', 'title': 'ECG Measures - Heart Rate', 'time_frame': 'Baseline and Week 12', 'description': 'The range of heart rates for this study was between 49-144 beats per minute'}, {'type': 'PRIMARY', 'title': 'ECG Measures - QT Interval', 'time_frame': 'Baseline and Week 12', 'description': "Fridericia's formula QTc interval=QT interval/cubed root of the R-R interval. The Bazett's formula QTc=QT/squared root of the R-R interval."}, {'type': 'PRIMARY', 'title': 'Cardiovascular Adverse Events Reported During Treatment Period', 'time_frame': '12-Week Treatment Period', 'description': 'Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Treatment Period. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event. Please see the category titles for a list of candidate cardiovascular adverse events.'}, {'type': 'PRIMARY', 'title': 'Cardiovascular Adverse Events Reported During the Post-Treatment Period', 'time_frame': '5 Days after Week 12', 'description': 'Cardiovascular Adverse Events, as categorized by the Medical Dictionary for Regulatory Activities (MeDRA), reported during Post-treatment period, defined as 1 day after last dose of study drug. The Adverse Events were identified in any ECG interpretation by a central reader (Cardiologist) for any ECG obtained after the first treatment dose and were then reported by the Primary Investigator as an Adverse Event.'}, {'type': 'PRIMARY', 'title': 'Asthma Exacerbations: Worsening of Asthma Requiring Emergency Intervention, Hospitalization, or Treatment With Asthma Medications Prohibited by the Protocols', 'time_frame': 'Treatment period (weeks 1-12)', 'description': "The Primary Investigator determined the severity of the exacerbation based on the participant's clinical presentation and the investigator's understanding of the disease, the participant, and his or her clinical experiences. The severity of the exacerbation was not defined in the protocol. Mild: Usually treated at home. Prompt relief with inhaled short-acting beta2 agonist. Possible short course of oral systemic corticosteroids. Moderate: Usually requires office or emergency department visit. Relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for 1-2 days after treatment begins. Severe: Usually requires emergency department visit and likely hospitalization. Partial relief with frequent inhaled short-acting beta2 agonist. Oral systemic corticosteroids; some symptoms last for more than 3 days after treatment begins. Adjunctive therapies are helpful."}, {'type': 'PRIMARY', 'title': 'Number of Participants With the Indicated Levels of 24-hour Urinary Cortisol Excretion', 'time_frame': 'Baseline and week 12', 'description': '"Abnormal high cortisol excretion" and "Abnormal low cortisol excretion" are defined as above the upper limit of normal and below the lower limit of normal, respectively. The normal range for cortisol levels vary by age and gender. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12', 'time_frame': 'Baseline and Week 12', 'description': 'Normal range for Cortisol levels vary by age and gender. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio for Week12:Baseline for 24-hour Urinary Cortisol Excretion', 'time_frame': 'Baseline and Week 12', 'description': 'Normal range for Cortisol levels vary by age and gender. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).'}, {'type': 'PRIMARY', 'title': 'Number of Participants With the Indicated Levels of 24 Hour Urinary Cortisol Excretion by Spacer Use', 'time_frame': 'Baseline and Week 12', 'description': 'AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. "Abnormal high cortisol excretion" and "Abnormal low cortisol excretion" are defined as above the upper limit of normal and below the lower limit of normal, respectively. An abnormality is defined as a value of 24-hour urinary cortisol excretion that is outside the normal range. The normal range for 24-hour urinary cortisol excretion was provided by the central laboratory.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Values of 24 Hour Urinary Cortisol Excretion by Spacer Use at Baseline and Week 12', 'time_frame': 'Baseline and Week 12', 'description': 'AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.'}, {'type': 'PRIMARY', 'title': 'Geometric Mean Ratio for Week12: Baseline for 24 Hour Urinary Cortisol Excretion by Spacer Use', 'time_frame': 'Baseline and Week 12', 'description': 'AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs).'}, {'type': 'SECONDARY', 'title': 'Clinic Morning (AM) Forced Expiratory Volume in Participants 6-11 Years', 'time_frame': 'Baseline and week 12', 'description': 'FEV1 (Forced Expiratory Volume in 1 second) is the volume of air that can be forced out in one second, after taking a deep breath. FEV1 is measured using a spirometer and obtaining "best effort" from 3 to 8 measurements. Week 12 is the measure taken at Week 12.'}, {'type': 'SECONDARY', 'title': 'AM Peak Expiratory Flow', 'time_frame': 'Baseline and 12-Week Treatment Period', 'description': 'The peak expiratory flow (PEF) rate measures how fast a person can exhale air. It is used to compare to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43 inches is 147 Liters/minute (L/min), whose height is 66 inches is 454 L/min. Triplicate measurements taken for the best effort recorded.'}, {'type': 'SECONDARY', 'title': 'Asthma Symptom Scores', 'time_frame': 'Baseline and 12-Week Treatment Period', 'description': 'Each morning prior dosing or PEF, self-scored based on past 24 hours: 0=No symptoms, 1=Symptoms for one short period, 2=Symptoms for two or more short periods, 3=Frequent Symptoms which did not affect activities of daily living (ADL), 4=Frequent.'}, {'type': 'SECONDARY', 'title': 'Percentage of Symptom Free Days', 'time_frame': 'Baseline and 12-Week Treatment Period', 'description': 'Percentage of number of days without asthma symptoms based on Asthma Symptom Scores. Each morning prior to dosing or PEF, asthma symptoms were self-scored based on the past 24 hours: 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=frequent symptoms that did not affect activities of daily living (ADL), 4=frequent .'}, {'type': 'SECONDARY', 'title': 'Albuterol Use', 'time_frame': 'Baseline and 12-Week Treatment Period', 'description': 'Albuterol inhalation aerosol was used as a rescue or prophylactic and recorded daily by subject or caregiver. The number of puffs of albuterol over the previous 24 hour period prior to dosing was recorded.'}, {'type': 'SECONDARY', 'title': 'Percent of Albuterol-free Days', 'time_frame': 'Baseline and 12-Week Treatment Period', 'description': 'Percentage of days when Albuterol use was unnecessary based on daily record and symptom free days.'}, {'type': 'POST_HOC', 'title': 'Geometric Mean Values of 24-hour Urinary Cortisol Excretion at Baseline and Week 12', 'time_frame': 'Baseline and Week 12', 'description': 'A post-hoc analysis excluding participants with urine cortisol baseline values of \\>200 nanomoles/24 hours. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.'}, {'type': 'POST_HOC', 'title': 'Geometric Mean Ratio for Baseline:Week12 24-hour Urinary Cortisol Excretion', 'time_frame': 'Baseline and Week 12', 'description': 'A post-hoc analysis excluding participants with urine cortisol baseline values of \\>200 nmol/24 hrs. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value, nanomoles per 24 hours (nmol/24 hrs) .'}, {'type': 'POST_HOC', 'title': 'Geometric Mean Values of 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population at Baseline and Week 12', 'time_frame': 'Baseline and Week 12', 'description': 'AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. Geometric mean is the product of the values taken to the Nth root, where N is the number of values in the set of values.'}, {'type': 'POST_HOC', 'title': 'Geometric Mean Ratio for Baseline: Week 12 24-hour Urinary Cortisol Excretion by Spacer Use Excluding Participants With Abnormal Urinary Cortisol Excretion Values at Baseline From the Cortisol Population', 'time_frame': 'Baseline and Week 12', 'description': 'AeroChamber Plus spacers were provided for participants who demonstrated the inability to coordinate the use of an Meter Dose Inhaler at Visit 1. AeroChamber Plus spacer delivers 22% more medication than the original AeroChamber and is available in three mask sizes and without a mask. The data provided are a direct calculation of the Week 12 geometric mean divided by the baseline value,nanomoles per 24 hours (nmol/24 hrs) .'}], 'brief_summary': 'This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2010-09-23', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2007-02', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2008-01', 'completion_date_precision': 'month', 'primary_completion_date': '2008-01-31', 'primary_completion_month_year': '2008-01', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['fluticasone'], ['fluticasone', 'salmeterol']], 'intervention_normalization': [{'name': 'fluticasone propionate', 'selected_label': 'fluticasone propionate', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone'], 'unverified_label_components': [], 'items': [{'original': 'fluticasone propionate', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'fluticasone propionate/salmeterol', 'selected_label': 'fluticasone propionate/salmeterol', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['fluticasone', 'salmeterol'], 'unverified_label_components': [], 'items': [{'original': 'fluticasone propionate', 'component': 'fluticasone', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}