The goal of asthma treatment is to achieve and maintain asthma control and to reduce the
future risk of exacerbations. Inhaled corticosteroids (ICS) are considered as the most
effective anti- inflammatory treatment for all severities of persistent asthma. For children
>=5 years of age and adolescents whose asthma is uncontrolled, low-dose ICS plus adjunctive
therapy with long-acting beta agonist (LABA) is considered as effective. Thus, this study is
designed to evaluate the efficacy and safety of FF (ICS component)/VI (LABA component)
compared to FF alone for the treatment of asthma, in subjects aged 5 to 17 years old
currently uncontrolled on ICS. The study will be conducted over a total duration of
approximately 29 weeks: 4 week run-in period, 24-week double-blind treatment period and
1-week follow-up period. Subjects will be randomized to receive FDC of FF/VI or FF
administered via ELLIPTA dry powder inhaler (DPI). The dose of both FF/VI and FF alone will
be selected based on the age of subjects. Subjects will receive a short acting beta 2 agonist
(SABA) (albuterol /salbutamol) as a rescue medication throughout the study. A total of 870
subjects will be randomized in the study. Of this, 652 subjects will be aged 5 to 11 years
(cohort A), and 218 will be aged 12 to 17 years inclusive (cohort B). ELLIPTA is a registered
trademark of GlaxoSmithKline (GSK) group of companies.
FF/VI via ELLIPTA DPI,
FF via ELLIPTA DPI
Clinical Study Identifier
Last Modified on
5 November 2020
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