Effect of Inhaled Fluticasone Furoate on Short-term Growth in Paediatric Subjects With Asthma

Inclusion Criteria

• Aged 5 years to less than 12 years at Visit 1. At least 15 (25%) children of the total study population must be aged 5 to less than 8 years.
• Male or pre-menarchial female subjects.
• Subjects must be pre-adolescent without any signs of puberty (Tanner Stage 1).
• Normal range for their height and weight. Weight and height measurements should fall within the percentile range 3-97% of normal values for age according to Danish growth charts.
• Have a documented diagnosis of persistent asthma, as defined by the National Institutes of Health for at least 3 months prior to the Screening Visit.
• A pre-bronchodilatory forced expiratory flow in 1 second (FEV1) at Visit 1 (Screening) >=80% predicted. There should be no Short acting beta-agonist (SABA) use within 4 hours of this measurement.
• Using one of the following asthma therapies prior to entry into the study: SABA inhaler alone (e.g. salbutamol) on an as required basis and/or Regular non-inhaled corticosteroid (ICS) controller medications for asthma (e.g. cromones or leukotriene receptor antagonists) and/or Previously treated with ICS (equipotent to inhaled budesonide 39 degree celsius for more than five consecutive days within the week preceding the Screening Visit.
• Any significant abnormality or medical condition identified at the screening medical assessment (including serious psychological disorder) that in the Investigator's opinion, preclude entry into the study due to risk to the subject or that may interfere with the outcome of the study.
• Clinical visual evidence of candidiasis at Visit 1 (Screening).
• Use of any of the prohibited medications listed in protocol.
• Strenuous physical exercise within 3 hours of Visit 1 (Screening)
• Drug allergies: Any adverse reaction including immediate or delayed hypersensitivity to any intranasal, inhaled, or systemic corticosteroid therapy. Known or suspected sensitivity to the constituents of the ELLIPTA Inhaler (i.e., lactose, FF).
• Milk Protein Allergy: History of severe milk protein allergy.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Exposure to more than 4 investigational medicinal products within 12 months prior to the first dosing day.
• Unable to use the ELLIPTA inhaler and peak flow meter correctly.
• An affiliation with the Investigator site: the parents/guardians or child is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator.
• The Parent or Guardian has a history of psychiatric disease, intellectual deficiency, substance abuse or other condition (e.g. inability to read, comprehend or write) which may affect: validity of consent to participate in the study; adequate supervision of the subject during the study; compliance of subject with study medication and study procedures (e.g. completion of daily diary, attending scheduled clinic visits); subject safety and well-being.
• Children in care: Children who are wards of the government or state are not eligible for participation in this study.