- For all subjects: Between 5 and 17 years of age inclusive, at the time of signing the
- A history of symptoms consistent with a diagnosis of asthma for at least 6 months.
- Pre-bronchodilator FEV1 >50 percent to <=90 percent predicted normal. A minimum of 2
efforts that are considered acceptable (not necessarily repeatable) are required to be
- Lung function reversibility defined as an increase of >=12 percent in FEV1 within 10
to 40 minutes following 2 to 4 inhalations of salbutamol inhalation aerosol (or 1
nebulized treatment with albuterol/salbutamol solution). Use of a spacer is permitted.
- Uncontrolled asthma, with a childhood asthma control test (cACT)/ACT score <=19.
- Receiving stable asthma therapy (SABA inhaler plus ICS [total daily dose <=FP 250
micrograms (mcg) or equivalent]) for at least 4 weeks prior to Visit 1 (i.e.
- Able to replace their current SABA treatment with salbutamol aerosol inhaler at Visit
1 for use as needed for the duration of the study. Salbutamol metered dose inhaler
(MDI) will be administered with or without a spacer, to be used as determined by the
investigator. The use or non-use of the spacer should be consistent for an individual
subject throughout the study.
- Male or female subjects will be included. Females of reproductive potential must agree
to follow 1 of the options listed (which include abstinence) in the Modified List of
Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential
(FRP) from 30 days prior to the first dose of study medication and until at least five
terminal half-lives or until any continuing pharmacologic effect has ended, whichever
is longer after the last dose of study medication and completion of the follow-up
call. The investigator is responsible for ensuring that subjects understand how to
properly use these methods of contraception.
- Written informed consent from at least 1 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 the local requirement.
The study investigator is accountable for determining a child's capacity to assent to
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 the study requires them to be treated on an outpatient basis; subject
and their legal guardian(s) understand that they must comply with study medication and
study assessments including recording of PEF and rescue SABA use, attending scheduled
study visits, and being accessible by a telephone call.
- For subjects eligible for randomization; asthma control: uncontrolled asthma, with a
cACT/ACT score <=19.
- A technically acceptable pre-bronchodilator FEV1 >50 percent to <=90 percent predicted
normal at Visit 2. A minimum of 2 efforts that are considered acceptable and
repeatable following the over read are required to be eligible.
- Symptoms and rescue use: demonstrated and reported in a daily diary symptoms of asthma
(a score of >=1 on the day-time or night-time asthma symptom scores) and/or daily
albuterol/salbutamol on at least 3 of the last 7 consecutive days of the run-in period
(not including the date of randomization).
- Compliance with run-in medication: compliance is defined as use of run-in medication
on at least 4 of the last 7 consecutive days of the run-in period (not including the
date of randomization) recorded in the electronic subject diary.
- Compliance with completion of the daily diary reporting: defined as completion of all
questions on 4 out of the last 7 days during the run-in period (not including the date
- For all subjects: History of life threatening asthma defined as an asthma episode that
required intubation and/or was associated with hypercapnea, respiratory arrest or
- Any asthma exacerbation requiring the use of oral steroids within 6 weeks of Visit 1,
systemic or depot corticosteroids within 12 weeks of Visit 1, or ER attendance within
3 months of Visit 1 or hospitalization within 6 months of Visit 1.
- A culture documented or suspected bacterial or viral infection of the upper or lower
respiratory tract, sinus or middle ear that has not resolved within 4 weeks of Visit 1
and which 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 oropharyngeal candidiasis.
- Fasting blood glucose at screening >100 milligrams/deciliter (mg/dL) (5.6 moles per
- Obesity (Body Mass Index [BMI] above the 97th centile based on the centers for disease
control and prevention [CDC] charts).
- 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 conduct and/or outcome of the study.
- QTc >450 milliseconds (msec) or QTc >480 msec in subjects with bundle branch block or
any other clinically significant abnormality in the screening 12-lead ECG.
- Use of any prohibited medications.
- Present use of any tobacco products.
- Drug allergies: any adverse reaction including immediate or delayed hypersensitivity
to any beta 2-agonists, sympathomimetic drug or any intranasal, inhaled, or systemic
corticosteroid therapy. Known or suspected sensitivity to the constituents of the
ELLIPTA Inhaler (i.e. lactose or magnesium stearate).
- Milk Protein Allergy: history of severe milk protein allergy.
- 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,
five half-lives or twice the duration of the biological effect of the study treatment
(whichever is longer).
- Exposure to more than 4 investigational medicinal products within 12 months prior to
the first dosing day.
- 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 (example, 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 (example, 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.
- For subjects eligible for randomization; Changes in asthma medication that occur after
- Occurrence of a culture-documented or suspected bacterial or viral infection of the
upper or lower respiratory tract, sinus or middle ear during the run-in period that
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.
- Evidence of an exacerbation, defined as a: deterioration of asthma requiring the use
of oral corticosteroids for at least 3 days, or a depot corticosteroid injection, or
an in-patient hospitalization due to asthma that required systemic corticosteroids
between screening and randomization.
- Clinical visual evidence of oropharyngeal candidiasis at the randomization Visit.
- Unable to use the ELLIPTA inhaler correctly.