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- Check4 days agoChange DetectedThe study has expanded to include 55 locations, and the revision has been updated from v2.9.7 to v2.10.0.SummaryDifference0.2%
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- Check32 days agoChange DetectedThe value 'Show more Show more Revision: v2.9.0' has recently changed to 'Show less MedlinePlus related topics: Asthma Children's Health Drug Information available for: Fluticasone propionate Fluticasone Fluticasone furoate FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : Randomized Interventional Model : Parallel Assignment Masking : Triple ( Participant Care Provider Investigator ) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Fluticasone furoate 50 mcg During run-in period, subjects will receive inhaled placebo for 16 weeks using ELLIPTA inhaler. Followed by treatment period where subjects will receive inhaled FF 50 mcg administered once daily in the morning for 52 weeks using ELLIPTA inhaler. Subjects will also receive open-label montelukast (4 milligrams [mg] for subjects who are 5 years old and 5 mg for subjects who are >= 6 years old) to be administered as one tablet of montelukast each evening for the duration of the study. Each subject will receive a SABA (albuterol/salbutamol [inhalation aerosol or nebuliser]) to be used as needed throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms. Drug : Fluticasone furoate Fluticasone furoate will be supplied as 50 mcg per blister dry white powder for inhalation using ELLIPTA inhaler. Drug : Placebo Placebo will be supplied as dry white powder Lactose for inhalation using ELLIPTA inhaler. Drug : Montelukast Montelukast will be supplied as 4 mg chewable tablet (5 year old subjects) and as 5 mg chewable tablet (>=6 year old subjects) Drug : Short Acting Beta 2 Agonist Albuterol/salbutamol will be supplied as inhalation aerosol or nebulizer. Placebo Comparator : Placebo During run-in period, subjects will receive inhaled placebo for 16 weeks using ELLIPTA inhaler. Followed by treatment period where subjects will receive inhaled placebo administered once daily in the morning for 52 weeks using ELLIPTA inhaler. Subjects will also receive open-label montelukast (4 milligrams [mg] for subjects who are 5 years old and 5 mg for subjects who are >=6 years old) to be administered as one tablet of montelukast each evening for the duration of the study. Each subject will receive a SABA (albuterol/salbutamol [inhalation aerosol or nebuliser]) to be used as needed throughout the entire study period as rescue medication for symptomatic relief of asthma symptoms. Drug : Placebo Placebo will be supplied as dry white powder Lactose for inhalation using ELLIPTA inhaler. Drug : Montelukast Montelukast will be supplied as 4 mg chewable tablet (5 year old subjects) and as 5 mg chewable tablet (>=6 year old subjects) Drug : Short Acting Beta 2 Agonist Albuterol/salbutamol will be supplied as inhalation aerosol or nebulizer. Primary Outcome Measures Outcome Measure Measure Description Time Frame Growth Velocity (Centimeter Per Year) Over the Double-blind Treatment Period, as Determined by Stadiometry Three reproducible height measurements were taken using a stadiometer at each visit and were recorded to nearest 1/10th of centimeter. Each set of triplicate measurements was averaged to derive one estimated height per participant per visit. Growth velocity was calculated for each participant over double-blind treatment period (up to 52 weeks [wk]) by fitting a regression line to averaged height measurements at each visit for that participant during period. Slope of this regression line was participant's growth velocity for double-blind treatment period. Treatment policy estimand was assessed, including all on- and post-treatment data. Baseline was included as covariate which was calculated based on stadiometric height measurements recorded at Visits 1(wk -16), 3(wk-8), and 5(wk0), data from at least two of these visits were used to fit a simple linear regression line against time and the slope of the fitted regression line was the participant's Baseline growth velocity. Up to 52 weeksSummaryDifference64%
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