A study to see if it is safe to give a new asthma controller drug (called fluticasone furoate) to 5 to 11 year old children with asthma.

• Conditions: Asthma; MedDRA version: 14.1Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-000753-31-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Research & Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

1. Male and pre-menarchial female subjects aged 5–11 years on the last planned
treatment day are eligible for this study. Pre-menarchial females are defined as any
female who has yet to begin menses and is considered Tanner Stage 2 or less.
2. Diagnosis of asthma at least 6 months prior to screening.
3. Patients must be controlled on their existing asthma treatment at screening as defined
by a Childhood Asthma Control Test score of >19 and PEF =80% predicted.
4. Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer from
no other significant medical conditions.
5. Subjects must be taking a stable regimen of a short acting beta-agonist inhaler on an
as-need basis for at least 4 weeks prior to screening.
6. Subjects must weigh at least 15 kg.
7. Subjects must demonstrate ability to accept and effectively use the fluticasone
furoate devices using the demonstration kits provided to the site.
8. Subjects and parents/guardians must be able to understand and comply with protocol
requirements, instructions and protocol-stated restrictions. Parents/guardians must
have the ability to read, write and record diary information collected throughout the
study. They must also have the ability to manage study drug administration and PEF
assessments.
9. A signed and dated written informed consent from at least one parent/guardian, and accompanying informed assent from the subject prior to admission to the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 26
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Subjects who have changed their asthma medication within 4 weeks of screening or
subjects currently being treated with inhaled corticosteroids or have received such
treatment within 4 weeks of screening. In addition, subjects currently receiving (or
have received within 4 weeks of screening) any of the following asthma therapies:
theophyllines, long-acting inhaled beta-agonists or oral beta-agonists.
2. Any medical condition or circumstance making the volunteer unsuitable for
participation in the study (e.g. history of life-threatening asthma).
3. Any clinically relevant abnormality identified on the screening medical assessment,
including asthma exacerbation requiring systemic corticosteroids (oral,
intramuscular, intravenous) or emergency room attendance within 3 months or
asthma exacerbation requiring hospitalization within 6 months prior to screening.
4. 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 screening
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.
5. Clinical visual evidence of oral candidiasis at screening.
6. Parent/guardian has history of psychiatric disease, intellectual deficiency, substance
abuse, or other condition (e.g., inability to read, comprehend and write) which will
limit the validity of consent to participate in this study.
7. Any adverse reaction including immediate or delayed hypersensitivity to any beta-2-
agonist, sympathomimetic drug, or any intranasal, inhaled or systemic corticosteroid
therapy.
8. Known or suspected sensitivity to the constituents of the novel dry powder inhaler
(i.e., lactose or magnesium stearate), for example, history of severe milk protein
allergy.
9. A subject will not be eligible for this study if he/she is an immediate family member
of the participating Investigator, sub-Investigator, study coordinator, or employee of
the participating Investigator.
10. Children who are wards of the state or government.
11. Evidence of clinically significant abnormality in the 12-lead ECG at screening, as
follows:

i. Ventricular rate <65 bpm or >115 bpm if aged 5–7 years.
ii. Ventricular rate <55 bpm or >110bpm if aged 8–11 years.
iii. PR interval >160 msec if aged 5–7 years.
iv. PR interval >170 msec if aged 8–11 years.
v. QRS >100 msec.
vi. Evidence of Mobitz II second degree or third degree AV block.
vii. Evidence of =2 unifocal ventricular ectopic beats, couplets,
bigeminy, trigeminy or multifocal premature ventricular
complexes on three ECG traces.
viii. QTcB >450 msec or an ECG that is not suitable for QT
measurements (e.g. poor defined termination of the T wave).
ix. Right or left complete bundle branch block.
x. Clinically significant conduction abnormalities (e.g. left bundle
branch block, Wolff-Parkinson-White syndrome).
xi. Clinically significant arrhythmias (e.g. atrial fibrillation, atrial
flutter, ventricular tachycardia).
xii. Non-sustained VT (3 or more consecutive ventricular beats greater
than 100 bpm).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified