Treatment Of Symptomatic Asthma In Children

details{'conditions': ['Asthma'], 'countries': ['Netherlands'], 'interventions': [{'name': 'Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg', 'type': 'DRUG', 'description': 'comparator'}, {'name': 'fluticasone propionate 2 x 100 mcg', 'type': 'DRUG', 'description': 'comparator'}], 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '1315 RA', 'city': 'Almere Stad', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '6815 AD', 'city': 'Arnhem', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '4819 EV', 'city': 'Breda', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5623 EJ', 'city': 'Eindhoven', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '7511JX', 'city': 'Enschede', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '2803 HG', 'city': 'Gouda', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '9713 GZ', 'city': 'Groningen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5707 HA', 'city': 'Helmond', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '1624 NP', 'city': 'Hoorn', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '8934 AD', 'city': 'Leeuwarden', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '6229 HX', 'city': 'Maastricht', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '6532 SZ', 'city': 'Nijmegen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '6131 BK', 'city': 'Sittard', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '2566 MJ', 'city': 'The Hague', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3584 CX', 'city': 'Utrecht', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5504 DB', 'city': 'Veldhoven', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '8025 AB', 'city': 'Zwolle', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period', 'time_frame': 'Last 10 weeks of the treatment period (Weeks 16-26)', 'description': "Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary."}, {'type': 'SECONDARY', 'title': 'Percentage of Symptom-free Days During the Entire Treatment Period', 'time_frame': 'Baseline to Week 26', 'description': "Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary"}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26', 'time_frame': 'Baseline and Week 26', 'description': 'Change from Baseline was calculated as the Week 26 value minus the Baseline value. The percentage predicted FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath and is corrected for the FEV1 value corresponding with the same age.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26', 'time_frame': 'Baseline and Week 26', 'description': 'Change from Baseline was calculated as the Week 26 value minus the Baseline value. Forced vital capacity is defined as the maximum volume of air that can be forcibly expired from the lungs and is calculated by use of spirometry. The spirometry test is performed by using a device called a spirometer, which measures the amount of air one can blow out maximally. Generally, the participant is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible. The test is normally repeated three times to ensure reproducibility.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26', 'time_frame': 'Baseline and Week 26', 'description': 'Change from Baseline was calculated as the Week 26 value minus the Baseline value. MEF 50 is defined as maximum expiratory flow rate at 50% of vital capacity. Vital capacity is the maximum amount of air that a person can expel from the lungs after first filling the lungs to their maximum extent. Midexpiratory flow was calculated by use of spirometry. The test is normally repeated at least three times in order to ensure reproducibility.'}, {'type': 'SECONDARY', 'title': 'Geometric Means of Nitric Oxide (NO) at Week 26', 'time_frame': 'Baseline and Week 26', 'description': 'Geometric mean values of NO at week 26 were compared using ANCOVA with adjustment for baseline value of NO, age, gender and center. Analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in RINT Measurements at Week 26', 'time_frame': 'Baseline and Week 26', 'description': 'Change from Baseline was calculated as the Week 26 value minus the Baseline value. Interrupter respiratory resistance (RINT) measurements were calculated by a combined analysis for relation between change from baseline and occurrence of the endpoint. RINT is a technique that is used for evaluating lung function in poorly collaborating patients (e.g., small children). The measurement is performed during tidal breathing (normal breathing) instead of during maximal expiration, as is done by a spirometry test.'}, {'type': 'SECONDARY', 'title': 'Number of Asthma Exacerbations Per Treatment Group at Week 26', 'time_frame': 'Week 26', 'description': 'An exacerbation is defined as a worsening of the asthma complaints (commonly referred to as an asthma attack) and is reported by the participant experiencing the event. An exacerbation was verified by the use of asthma rescue medication.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26', 'time_frame': 'Baseline and Week 26', 'description': 'PD20 was calculated by using increasing dosages of methacholine. The dosage that caused a 20% fall in FEV1 was used for analysis. The presented data are ratios (month 6/Baseline) of geometric mean PD20 values.'}, {'type': 'SECONDARY', 'title': 'Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres', 'time_frame': '26 weeks', 'description': 'Bronchial hyperresponsiveness with PD20 AMP in selected centres was not analyzed, as this outcome measure was removed in a protocol amendment.'}, {'type': 'SECONDARY', 'title': 'Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)', 'time_frame': '26 weeks', 'description': 'Daily FEV1 and PEF via the electronic pea kflow/FEV1 meter (PIKO-1) was not assessed because data from the peak flow meters could not be used for analysis.'}, {'type': 'SECONDARY', 'title': 'Frequency of Asthma Exacerbations (Discriminated on Severity)', 'time_frame': '26 weeks', 'description': 'The frequency of asthma exacerbations (discriminated on severity) was not analyzed because of the low overall frequency.'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Symptom-free Weeks Until the End of Treatment', 'time_frame': '26 weeks', 'description': 'This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.'}, {'type': 'SECONDARY', 'title': "Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks'", 'time_frame': '26 weeks', 'description': 'This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.'}, {'type': 'SECONDARY', 'title': "Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week'", 'time_frame': '26 weeks', 'description': 'This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.'}], 'brief_summary': 'This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2009-12-14', 'has_results_basis': 'results_first_posted_date'}→{'conditions': ['Asthma'], 'countries': ['Netherlands'], 'interventions': [{'name': 'Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg', 'type': 'DRUG', 'description': 'comparator', 'other_names': [], 'design_groups': [{'id': 421345247, 'type': 'ACTIVE_COMPARATOR', 'title': 'Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg', 'description': 'Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg'}]}, {'name': 'fluticasone propionate 2 x 100 mcg', 'type': 'DRUG', 'description': 'comparator', 'other_names': ['Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg'], 'design_groups': [{'id': 421345248, 'type': 'OTHER', 'title': 'fluticasone propionate 2 x 100 mcg', 'description': 'fluticasone propionate 2 x 100 mcg'}]}], 'composition_semantics': 'study_intervention_labels_not_product_formula', 'sponsors': [{'name': 'GlaxoSmithKline', 'role': 'lead', 'agency_class': 'INDUSTRY'}], 'facilities': [{'zip': '1315 RA', 'city': 'Almere Stad', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '1105 AZ', 'city': 'Amsterdam', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '6815 AD', 'city': 'Arnhem', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '4819 EV', 'city': 'Breda', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5623 EJ', 'city': 'Eindhoven', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '7511JX', 'city': 'Enschede', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '2803 HG', 'city': 'Gouda', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '9713 GZ', 'city': 'Groningen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5707 HA', 'city': 'Helmond', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '1624 NP', 'city': 'Hoorn', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '8934 AD', 'city': 'Leeuwarden', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '6229 HX', 'city': 'Maastricht', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '6532 SZ', 'city': 'Nijmegen', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '6131 BK', 'city': 'Sittard', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '2566 MJ', 'city': 'The Hague', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '3584 CX', 'city': 'Utrecht', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '5504 DB', 'city': 'Veldhoven', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}, {'zip': '8025 AB', 'city': 'Zwolle', 'name': 'GSK Investigational Site', 'state': None, 'country': 'Netherlands'}], 'outcomes': [{'type': 'PRIMARY', 'title': 'Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period', 'time_frame': 'Last 10 weeks of the treatment period (Weeks 16-26)', 'description': "Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary."}, {'type': 'SECONDARY', 'title': 'Percentage of Symptom-free Days During the Entire Treatment Period', 'time_frame': 'Baseline to Week 26', 'description': "Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary"}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26', 'time_frame': 'Baseline and Week 26', 'description': 'Change from Baseline was calculated as the Week 26 value minus the Baseline value. The percentage predicted FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath and is corrected for the FEV1 value corresponding with the same age.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26', 'time_frame': 'Baseline and Week 26', 'description': 'Change from Baseline was calculated as the Week 26 value minus the Baseline value. Forced vital capacity is defined as the maximum volume of air that can be forcibly expired from the lungs and is calculated by use of spirometry. The spirometry test is performed by using a device called a spirometer, which measures the amount of air one can blow out maximally. Generally, the participant is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible. The test is normally repeated three times to ensure reproducibility.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26', 'time_frame': 'Baseline and Week 26', 'description': 'Change from Baseline was calculated as the Week 26 value minus the Baseline value. MEF 50 is defined as maximum expiratory flow rate at 50% of vital capacity. Vital capacity is the maximum amount of air that a person can expel from the lungs after first filling the lungs to their maximum extent. Midexpiratory flow was calculated by use of spirometry. The test is normally repeated at least three times in order to ensure reproducibility.'}, {'type': 'SECONDARY', 'title': 'Geometric Means of Nitric Oxide (NO) at Week 26', 'time_frame': 'Baseline and Week 26', 'description': 'Geometric mean values of NO at week 26 were compared using ANCOVA with adjustment for baseline value of NO, age, gender and center. Analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables.'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in RINT Measurements at Week 26', 'time_frame': 'Baseline and Week 26', 'description': 'Change from Baseline was calculated as the Week 26 value minus the Baseline value. Interrupter respiratory resistance (RINT) measurements were calculated by a combined analysis for relation between change from baseline and occurrence of the endpoint. RINT is a technique that is used for evaluating lung function in poorly collaborating patients (e.g., small children). The measurement is performed during tidal breathing (normal breathing) instead of during maximal expiration, as is done by a spirometry test.'}, {'type': 'SECONDARY', 'title': 'Number of Asthma Exacerbations Per Treatment Group at Week 26', 'time_frame': 'Week 26', 'description': 'An exacerbation is defined as a worsening of the asthma complaints (commonly referred to as an asthma attack) and is reported by the participant experiencing the event. An exacerbation was verified by the use of asthma rescue medication.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26', 'time_frame': 'Baseline and Week 26', 'description': 'PD20 was calculated by using increasing dosages of methacholine. The dosage that caused a 20% fall in FEV1 was used for analysis. The presented data are ratios (month 6/Baseline) of geometric mean PD20 values.'}, {'type': 'SECONDARY', 'title': 'Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres', 'time_frame': '26 weeks', 'description': 'Bronchial hyperresponsiveness with PD20 AMP in selected centres was not analyzed, as this outcome measure was removed in a protocol amendment.'}, {'type': 'SECONDARY', 'title': 'Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)', 'time_frame': '26 weeks', 'description': 'Daily FEV1 and PEF via the electronic pea kflow/FEV1 meter (PIKO-1) was not assessed because data from the peak flow meters could not be used for analysis.'}, {'type': 'SECONDARY', 'title': 'Frequency of Asthma Exacerbations (Discriminated on Severity)', 'time_frame': '26 weeks', 'description': 'The frequency of asthma exacerbations (discriminated on severity) was not analyzed because of the low overall frequency.'}, {'type': 'SECONDARY', 'title': 'Cumulative Number of Symptom-free Weeks Until the End of Treatment', 'time_frame': '26 weeks', 'description': 'This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.'}, {'type': 'SECONDARY', 'title': "Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks'", 'time_frame': '26 weeks', 'description': 'This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.'}, {'type': 'SECONDARY', 'title': "Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week'", 'time_frame': '26 weeks', 'description': 'This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.'}], 'brief_summary': 'This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.', 'study_type': 'INTERVENTIONAL', 'source_organization': 'GlaxoSmithKline', 'results_first_posted_date': '2009-12-14', 'has_results_basis': 'results_first_posted_date', 'start_date_type': None, 'start_month_year': '2005-06', 'start_date_precision': 'month', 'completion_date_type': 'ACTUAL', 'completion_month_year': '2008-10', 'completion_date_precision': 'month', 'primary_completion_date': '2008-10-31', 'primary_completion_month_year': '2008-10', 'primary_completion_date_precision': 'month', 'primary_completion_date_type': 'ACTUAL', 'intervention_component_groups': [['salmeterol', 'unmapped:100-mcg', 'unmapped:fluticasone-propionate-diskus-inhaler-50'], ['unmapped:fluticasone-propionate-2-x-100-mcg']], 'intervention_normalization': [{'name': 'Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg', 'selected_label': 'Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['salmeterol', 'unmapped:100-mcg', 'unmapped:fluticasone-propionate-diskus-inhaler-50'], 'unverified_label_components': ['unmapped:100-mcg', 'unmapped:fluticasone-propionate-diskus-inhaler-50'], 'items': [{'original': 'Salmeterol', 'component': 'salmeterol', 'status': 'resolved', 'method': 'versioned_lexicon'}, {'original': 'fluticasone propionate Diskus® inhaler 50', 'component': 'unmapped:fluticasone-propionate-diskus-inhaler-50', 'status': 'unresolved', 'method': 'no_verified_mapping'}, {'original': '100 mcg', 'component': 'unmapped:100-mcg', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}, {'name': 'fluticasone propionate 2 x 100 mcg', 'selected_label': 'fluticasone propionate 2 x 100 mcg', 'selection_basis': 'primary_label', 'role': 'study_intervention', 'components': ['unmapped:fluticasone-propionate-2-x-100-mcg'], 'unverified_label_components': ['unmapped:fluticasone-propionate-2-x-100-mcg'], 'items': [{'original': 'fluticasone propionate 2 x 100 mcg', 'component': 'unmapped:fluticasone-propionate-2-x-100-mcg', 'status': 'unresolved', 'method': 'no_verified_mapping'}], 'excluded_accessory_parts': [], 'verified_other_name_component_sets': []}]}