A PHASE III, RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED CROSSOVER STUDY TO COMPARE THE SYSTEMIC EFFECTS OF INHALED FLUTICASONE PROPIONATE HFA MDI 200?g PER DAY VERSUS THE REFERENCE FLUTICASONE PROPIONATE HFA MDI 200?g PER DAY ON SHORT-TERM LINEAR GROWTH AND ON HPA-AXIS FUNCTION IN PRE-PUBERTAL CHILDREN WITH MILD ASTHMA. - NEO014

INTERVENTION: Product Name: Fluticasone Propionate 50 MCG HFA MDI Pharmaceutical Form: Inhalation vapour, solution Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administration of the placebo: Inhalation use Trade Name: Flixotide 50 MCG Evohaler Product Name: Flixotide 50 MCG Evohaler Pharmaceutical Form: Inhalation vapour, solution Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administration of the placebo: Inhalation use CONDITION: Mild asthma in pre‐pubertal children. ; MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma PRIMARY OUTCOME: Main Objective: To show that the test inhaled fluticasone (plus Volumatic spacer) has a non‐inferior effect on short‐term linear growth in pre‐pubertal children with asthma as compared to a reference fluticasone inhaler (Flixotide Evohaler ®) plus Volumatic spacer.; ; Primary variable: ; • Growth velocity of the right lower leg as measured by knemometry.; ; Primary end point(s): Growth velocity of the right lower leg as measured by knemometry. Secondary Objective: Secondary variables:; • HPA‐axis function (overnight urinary free cortisol);; • Lung function from spirometry (FEV1);; • Use of rescue medication from diary.; • FENO; INCLUSION CRITERIA: 1. Written informed consent by the patient’s parents or legal guardians. 2. Female outpatients aged 6 to 11 years, or male outpatients aged 6 to 12 years. 3. Pre‐pubertal stage, i.e.: a. Females: breasts ? Tanner stage I. b. Males: testicular volume ? 2 ml measured with a Prader orchidometer. 4. Good health with the exception of asthma. 5. History of mild asthma for at least 6 months as defined by ATS criteria. 6. Currently (i.e. for at least 3 weeks) using inhaled short acting beta‐agonists and/or prn use of long acting inhaled beta‐agonists, the latter of a maximum of 5 times per week. Other orally administered bronchodilators, theophylline, leukotriene antagonists, lipoxygenase inhibitors, cromones or ketotifen, are permitted but the dosage must be maintained constant throughout the study. 7. FEV1 ? 80% predicted (measured at least 6 hours after the inhalation of a short acting beta‐agonist or after 10 hours after inhalation of a long