Effects of a Orally Inhaled Fluticasone Furoate on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma Over a Year

Inclusion Criteria:

- Male or female subjects.

- Age: Males between 5 and <9 years old; Females between 5 and <8 years old.

- Subjects must be pre-pubertal (Tanner Stage 1).

- Height centile between 3% and 97% based on local growth charts.

- Subjects with body weight and body mass index that is between 3rd and 97th centile
based on the United State (US) Centres for Disease Control and Prevention (CDC)
standard statistics or any local standards outside the US.

- A documented history of symptoms consistent with a diagnosis of asthma for at least 6
months prior to Visit 1.

- A pre-bronchodilatory forced expiratory flow in 1 second (FEV1) at Visit 1 (Screening)
of between >=60% to <=95% predicted. There should be no short acting beta 2 agonist
(SABA) use within 4 hours of this measurement.

- Able to replace their current SABA treatment with study supplied rescue
albuterol/salbutamol provided at Visit 1 for use as needed for the duration of the
study.

- A childhood asthma control test (cACT) score of >19.

- Subjects should have required at least one course of corticosteroid for their asthma
(inhaled or oral) in the past year.

- There must be no ICS use within 6 weeks of Visit 1 (Screening).

- There must be no oral corticosteroids use within 12 weeks of Visit 1 (Screening).

- Using one or more of the following asthma therapies prior to entry into the study:

Short acting beta-agonist (SABA) inhaler alone (example given [e.g.] salbutamol) on an as
needed basis and/or regular non-ICS controller medications for asthma (e.g. cromones or
leukotriene receptor antagonists).

- Written informed consent from at least one parent/care giver (legal guardian) and
accompanying informed assent from the subject (where the subject is able to provide assent)
prior to admission to the study. If applicable, subject must be able and willing to give
assent to take part in the study according to local requirement. The study investigator is
accountable for determining a child's capacity to assent for participation in a research
study, taking into consideration any standards set by the responsible Independent Ethics
Committee (IEC). Subject and their legal guardian(s) understand that they must comply with
study medication administration regimens and study assessments including recording of
symptom scores and rescue albuterol/salbutamol use, attending all study visits, and being
accessible by telephone.

Exclusion Criteria:

- Growth Criteria: Any previous or current condition that affects growth, including
sleep disorders, endocrine disorders, skeletal dysplasia, Turner and Noonan syndromes,
Marfan, Beckwith-Wiedeman and Sotos syndromes, Klinefelter's syndrome, coeliac
disease, inflammatory bowel diseases and renal failure or any significant abnormality
or medical condition that is identified at the screening medical assessment (including
serious psychological disorder) that is likely to interfere with the conduct of the
study.

- Subjects with premature adrenarche.

- A child who is unable to stand, or who finds standing difficult due to illness or
physical disabilities should be excluded.

- Disease Criteria: Subjects with a history of asthma exacerbation requiring the use of
systemic corticosteroids (tablets, suspension, or injection) for at least 3 days or
use of a depot corticosteroid injection within 3 months or those requiring
hospitalisation for asthma (within 6 months) prior to screening.

- 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.

- Clinical visual evidence of candidiasis at Visit 1 (Screening).

- Any significant abnormality or medical condition identified at the screening medical
assessment 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.

- General: Prior use of any medication or treatment that might affect growth including,
but not limited to: amphetamines, anticonvulsants, biphosphonates, calcitonin,
calcitriol, erythropoietin, growth hormone, methylphenidate, phosphate binders,
antithyroid drugs (e.g., Methimazole) or thyroid hormone.

- Use of any of the prohibited medications listed in the study protocol.

- Hypersensitivity: Known hypersensitivity to corticosteroids, leukotrienes, or any
excipients in the ELLIPTA (ELLIPTA is a Glaxosmithkline owned trademark for dry powder
inhaler) inhaler and study tablets.

- 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.

- Children who are 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 known or suspected 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.