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



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:5 - 9
Updated:9/27/2018
Start Date:October 20, 2016
End Date:October 31, 2021
Contact:US GSK Clinical Trials Call Center
Email:GSKClinicalSupportHD@gsk.com
Phone:877-379-3718

Use our guide to learn which trials are right for you!

Study HZA114971, A Multicentre Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effects of a One-Year Regimen of Orally Inhaled Fluticasone Furoate 50 mcg Once Daily on Growth Velocity in Prepubertal, Paediatric Subjects With Asthma

There is a regulatory requirement to evaluate the extent of reduction (if any) of growth
velocity associated with inhaled corticosteroid (ICS) containing products that are to be
administered to children, and to this end there is Food and Drug Administration (FDA)
regulatory guidance. This is a randomised, single-blind (run-in period)/double-blind
(treatment period), parallel group, placebo controlled, multicentre study to assess the
effect of once daily (OD) inhaled fluticasone furoate (FF) 50 microgram (mcg) on growth
velocity in prepubertal asthmatic children on a background therapy of open-label montelukast.
This study will be conducted over a total duration of approximately 76 weeks: 16-week run-in
period (single-blind placebo inhaler), 52-week double-blind treatment period (inhaled FF 50
mcg /placebo administered OD in the morning for 52 weeks) and 8-week follow-up period. The
purpose of the study is to evaluate the magnitude of effect (with a level of precision) on
growth velocity of prepubertal asthmatic paediatric subjects (aged 5 to <9 years) following
administration of OD inhaled FF 50 mcg for one year. This study fulfills European Union (EU)
and United States (US) regulatory requirements for the evaluation of potential growth
suppression in children.


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.
We found this trial at
19
sites
Miami, Florida 33136
Phone: 877-379-3718
?
mi
from
Miami, FL
Click here to add this to my saved trials
Bellevue, Nebraska 68123
Phone: 877-379-3718
?
mi
from
Bellevue, NE
Click here to add this to my saved trials
Ciudad Autonoma de Buenos Aires, Buenos Aires
Phone: 877-379-3718
?
mi
from
Ciudad Autonoma de Buenos Aires,
Click here to add this to my saved trials
Gainesville, Georgia 30501
Phone: 877-379-3718
?
mi
from
Gainesville, GA
Click here to add this to my saved trials
Homestead, Florida 33030
Phone: 877-379-3718
?
mi
from
Homestead, FL
Click here to add this to my saved trials
Huntington Beach, California 92647
Phone: 877-379-3718
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Little Rock, Arkansas 72205
Phone: 877-379-3718
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Loxahatchee Groves, Florida 33470
Phone: 877-379-3718
?
mi
from
Loxahatchee Groves, FL
Click here to add this to my saved trials
Medford, Oregon 97504
Phone: 877-379-3718
?
mi
from
Medford, OR
Click here to add this to my saved trials
Ocala, Florida 34471
Phone: 877-379-3718
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73112
Phone: 877-379-3718
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orangeburg, South Carolina 29118
Phone: 877-379-3718
?
mi
from
Orangeburg, SC
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15213
Phone: 877-379-3718
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Raleigh, North Carolina 27614
Phone: 877-379-3718
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Rolling Hills Estates, California 90274
Phone: 877-379-3718
?
mi
from
Rolling Hills Estates, CA
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
Phone: 877-379-3718
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
San Antonio, Texas 78258
Phone: 877-379-3718
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
Waco, Texas 76712
Phone: 877-379-3718
?
mi
from
Waco, TX
Click here to add this to my saved trials
Ypsilanti, Michigan 48197
Phone: 877-379-3718
?
mi
from
Ypsilanti, MI
Click here to add this to my saved trials