A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:5 - 11
Updated:11/8/2014
Start Date:January 2012
End Date:January 2015
Contact:Toll Free Number
Phone:1-888-577-8839

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A 12-Week, Randomized, Placebo-Controlled, Dose-Ranging, Efficacy and Safety Study of Mometasone Furoate Metered Dose Inhaler in the Treatment of Children Ages 5 to 11 Years With Persistent Asthma

The primary objective of this study is to demonstrate the dose-related efficacy, by
evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent
predicted forced expiratory volume in one second [FEV1]) across 12 weeks of treatment, of
three doses (50 mcg, 100 mcg, and 200 mcg) of Mometasone Furoate (MF) Metered Dose Inhaler
(MDI) twice a day (BID) compared with Placebo.


Inclusion Criteria:

- Diagnosis of asthma of at least 6 months duration.

- Using an Inhaled corticosteroid (ICS) - either alone or in combination with a
Long-acting beta-2 agonist (LABA) - for at least 12 weeks prior to the Screening
Visit and must have been on a stable asthma regimen for at least 2 weeks prior to the
Screening Visit, must not have used oral glucocorticosteroids within 30 days of the
Screening Visit.

Exclusion Criteria:

- Treated in the emergency room for a severe asthma exacerbation requiring systemic
glucocorticosteroid treatment, or hospitalization for management of airway
obstruction within 3 months prior to the Screening Visit.

- History of ventilator support for respiratory failure secondary to asthma.

- Upper or lower respiratory tract infection (viral or bacterial) within the 2 weeks
prior to Screening and Baseline Visits.

- History of clinically significant renal, hepatic, cardiovascular, metabolic,
neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal,
cerebrovascular, or other significant medical illness or disorder which, in the

judgment of the investigator, could interfere with the study or require treatment that
might interfere with the study. Specific examples include but are not limited to
insulin-dependent diabetes, hypertension, active hepatitis, cardiovascular disease
including hypertension, or conditions that may interfere with respiratory function such
as, bronchiectasis, and cystic fibrosis. Other conditions that are well controlled and
stable will not prohibit participation if deemed appropriate per the investigator's
judgment.

- Allergy/sensitivity to glucocorticoids, beta-2 agonists, or study drug/excipients.

- Inability to correctly use an oral MDI or a DPI.

- Participation in this study at another investigational site. Participation in a
different investigational study at any site during the same timeframe of this study.

- Randomization into this study more than once.

- Direct association with either the administration of the this study or the study
staff.
We found this trial at
16
sites
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Miami Lakes, FL
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Arlington, TX
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Bellevue, NE
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Boerne, TX
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Corning, NY
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Dallas, TX
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Dallas, TX
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Huntington Beach, California 92646
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Huntington Beach, CA
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Lebanon, TN
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Miami, FL
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Normal, IL
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Raleigh, NC
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San Antonio, TX
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Stockton, CA
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Waco, TX
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Warrensburg, MO
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