A history of life-threatening asthma defined for this protocol as an asthma episode that required intubation, hypercapnea requiring non-invasive ventilatory support, respiratory arrest, hypoxic seizures or asthma-related syncopal episode(s). 
Subjects with a history of asthma exacerbation requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or a depot corticosteroid injection or emergency room attendance (within 3 months) or requiring hospitalization for asthma (within 6 months) prior to screening. 
Significant, non-reversible active pulmonary disease (e.g. cystic fibrosis, bronchiectasis, tuberculosis). 
Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of Visit 1 and led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject's asthma status or the subject's ability to participate in the study. 
Any fracture in the leg to be measured within 6 months prior to the screening visit. 
Any metabolic disorders or other diseases that may impact on normal growth patterns. 
No major surgery requiring general anaesthesia for at least 3 months prior to the screening visit. 
No febrile illnesses with temperature >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.       
    

NCT02502734_exc_T1
Condition
asthma
NCT02502734_exc_T2
Qualifier
life-threatening
NCT02502734_exc_T3
Observation
history
NCT02502734_exc_T4
Procedure
intubation
NCT02502734_exc_T5
Condition
asthma episode
NCT02502734_exc_T6
Condition
hypercapnea
NCT02502734_exc_T7
Device
non-invasive ventilatory support
NCT02502734_exc_T8
Condition
respiratory arrest
NCT02502734_exc_T9
Condition
hypoxic seizures
NCT02502734_exc_T10
Condition
asthma-related syncopal episode
NCT02502734_exc_T11
Scope
asthma episode that required intubation, hypercapnea requiring non-invasive ventilatory support, respiratory arrest, hypoxic seizures or asthma-related syncopal episode
NCT02502734_exc_T12
Observation
history
NCT02502734_exc_T13
Condition
asthma exacerbation
NCT02502734_exc_T14
Drug
systemic corticosteroids
NCT02502734_exc_T15
Temporal
for at least 3 days
NCT02502734_exc_T16
Drug
depot corticosteroid injection
NCT02502734_exc_T17
Temporal
within 3 months
NCT02502734_exc_T18
Procedure
emergency room attendance
NCT02502734_exc_T19
Procedure
hospitalization
NCT02502734_exc_T20
Condition
asthma
NCT02502734_exc_T21
Temporal
within 6 months
NCT02502734_exc_T22
Condition
pulmonary disease
NCT02502734_exc_T24
Qualifier
Significant
NCT02502734_exc_T26
Qualifier
non-reversible
NCT02502734_exc_T27
Temporal
active
NCT02502734_exc_T28
Condition
cystic fibrosis
NCT02502734_exc_T29
Condition
bronchiectasis
NCT02502734_exc_T30
Condition
tuberculosis
NCT02502734_exc_T31
Scope
cystic fibrosis, bronchiectasis, tuberculosis
NCT02502734_exc_T32
Condition
viral infection of the upper respiratory tract
NCT02502734_exc_T33
Condition
bacterial infection of the upper respiratory tract
NCT02502734_exc_T34
Condition
viral infection of the lower respiratory tract
NCT02502734_exc_T35
Condition
bacterial infection of the lower respiratory tract
NCT02502734_exc_T36
Condition
viral infection of the sinus
NCT02502734_exc_T37
Condition
bacterial infection of the sinus
NCT02502734_exc_T38
Condition
viral infection of the middle ear
NCT02502734_exc_T39
Condition
bacterial infection of the middle ear
NCT02502734_exc_T40
Procedure
Culture
NCT02502734_exc_T41
Observation
suspected
NCT02502734_exc_T42
Scope
Culture-documented or suspected
NCT02502734_exc_T43
Scope
bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear
NCT02502734_exc_T44
Qualifier
resolved
NCT02502734_exc_T45
Negation
not
NCT02502734_exc_T46
Temporal
within 4 weeks of Visit 1
NCT02502734_exc_T47
Reference_point
Visit 1
NCT02502734_exc_T48
Observation
change in asthma management
NCT02502734_exc_T53
Procedure
asthma management
NCT02502734_exc_T54
Condition
fracture in the leg
NCT02502734_exc_T55
Temporal
within 6 months prior to the screening visit
NCT02502734_exc_T56
Reference_point
the screening visit
NCT02502734_exc_T57
Condition
metabolic disorders
NCT02502734_exc_T58
Qualifier
may impact on normal growth patterns
NCT02502734_exc_T61
Condition
other diseases
NCT02502734_exc_T62
Scope
metabolic disorders or other diseases
NCT02502734_exc_T63
Condition
major surgery
NCT02502734_exc_T65
Procedure
general anaesthesia
NCT02502734_exc_T66
Temporal
for at least 3 months prior to the screening visit
NCT02502734_exc_T67
Reference_point
the screening visit
NCT02502734_exc_T68
Condition
febrile illnesses
NCT02502734_exc_T69
Negation
No
NCT02502734_exc_T71
Measurement
temperature
NCT02502734_exc_T72
Value
>39 degree celsius
NCT02502734_exc_T73
Temporal
for more than five consecutive days
NCT02502734_exc_T74
Temporal
within the week preceding the Screening Visit
NCT02502734_exc_T75
Reference_point
the Screening Visit
NCT02502734_exc_T76
Negation
No
NCT02502734_exc_T77
Qualifier
significant
NCT02502734_exc_T80
Condition
abnormality
NCT02502734_exc_T81
Condition
medical condition
NCT02502734_exc_T82
Scope
abnormality or medical condition
NCT02502734_exc_T86
Condition
visual evidence
NCT02502734_exc_T87
Condition
candidiasis
NCT02502734_exc_T88
Temporal
at Visit 1 (Screening)
NCT02502734_exc_T89
Reference_point
Visit 1 (Screening)
NCT02502734_exc_T91
Drug
prohibited medications listed in protocol
NCT02502734_exc_T92
Condition
Strenuous physical exercise
NCT02502734_exc_T93
Temporal
within 3 hours of Visit 1 (Screening)
NCT02502734_exc_T94
Reference_point
Visit 1 (Screening)
NCT02502734_exc_T95
Condition
Drug allergies
NCT02502734_exc_T96
Drug
intranasal corticosteroid
NCT02502734_exc_T97
Drug
systemic corticosteroid
NCT02502734_exc_T98
Drug
inhaled corticosteroid
NCT02502734_exc_T99
Scope
intranasal, inhaled, or systemic corticosteroid
NCT02502734_exc_T100
Condition
immediate hypersensitivity
NCT02502734_exc_T101
Condition
delayed hypersensitivity
NCT02502734_exc_T102
Condition
adverse reaction
NCT02502734_exc_T103
Scope
immediate or delayed hypersensitivity
NCT02502734_exc_T104
Scope
adverse reaction including immediate or delayed hypersensitivity to any intranasal, inhaled, or systemic corticosteroid
NCT02502734_exc_T105
Condition
sensitivity
NCT02502734_exc_T106
Drug
constituents of the ELLIPTA Inhaler
NCT02502734_exc_T107
Drug
lactose
NCT02502734_exc_T108
Drug
FF
NCT02502734_exc_T109
Scope
lactose, FF
NCT02502734_exc_T110
Condition
Milk Protein Allergy
NCT02502734_exc_T111
Condition
milk protein allergy
NCT02502734_exc_T112
Qualifier
severe
NCT02502734_exc_T115
Multiplier
more than 4
NCT02502734_exc_T116
Drug
investigational medicinal products
NCT02502734_exc_T117
Temporal
within 12 months prior to the first dosing day
NCT02502734_exc_T118
Reference_point
the first dosing day
NCT02502734_exc_T119
Drug
ELLIPTA inhaler
NCT02502734_exc_T120
Device
peak flow meter
NCT02502734_exc_T121
Condition
Unable to use the ELLIPTA inhaler and peak flow meter correctly.