Study of Safety and Efficacy of Mometasone Furoate Used in Combination With Formoterol Fumarate Compared With Mometasone Furoate in Children (5 to 11 Years of Age) With Persistent Asthma (MK-0887A-087)



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:5 - 11
Updated:5/5/2017
Start Date:May 11, 2016
End Date:January 17, 2018
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase III, Randomized, Active-controlled, Parallel-group Clinical Trial to Study the Efficacy and Long-term Safety of Mometasone Furoate/Formoterol Fumarate (MF/F, MK-0887A [SCH418131]), Compared With Mometasone Furoate (MF, MK-0887 [SCH032088]), in Children With Persistent Asthma

This study will compare the efficacy and safety of mometasone furoate/formoterol fumarate
(MF/F) 100/10 mcg to mometasone furoate (MF) 100 mcg, both administered by metered-dose
inhaler, in 5- to 11-year-old children with persistent asthma. This study will evaluate the
change in forced expiratory volume in one second (FEV1) from baseline as a measure of
pulmonary function


Inclusion Criteria:

- Has a diagnosis of asthma of ≥ 6-months duration prior to study start

- Has asthma that is adequately controlled, according to the clinical judgment of the
investigator, on a stable dose of inhaled corticosteroid (ICS) combined with
long-acting beta-agonist (LABA) ≥ 4 weeks prior to study start

- Is able to demonstrate at screening, an FEV1 >60% and ≤90% predicted -Is able to
demonstrate at screening, an increase in absolute FEV1 of at least 12% within 30
minutes after administration of albuterol/salbutamol.

Exclusion Criteria:

- Requires >8 inhalations per day of albuterol (100 mcg per actuation), and/or >2
nebulized treatments per day of 2.5 mg albuterol on any 2 consecutive days between
the screening visit and the study start

- Has a clinical worsening of asthma between the screening visit and the study start,
that results in emergency room visit (for an asthma exacerbation), hospitalization
due to asthma, or treatment with additional, excluded asthma medication (other than
SABA).

- Has experienced an upper or lower respiratory tract infection within the 4 weeks
prior to screening

- Is considered by the investigator to have unstable asthma at the end of the run-in
period

- Has had > 4 asthma exacerbations (defined as a worsening of asthma requiring systemic
corticosteroid use and/or ≥ 24-hour stay in an emergency department, urgent care
center, or hospital) within 1 year of the screening visit

- Has had a history of life-threatening asthma, including an asthma episode that
required intubation and/or was associated with an increase in carbon dioxide levels
in the blood requiring non-invasive ventilator support
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