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

Organon

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg; Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg; Drug: Placebo Dry Powder Inhaler (DPI); Drug: Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg; Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg; Drug: Placebo Metered Dose Inhaler (MDI)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01502371

MK-0887-086 (Other Identifier)

P04223

2008-007504-28 (EudraCT Number)

Details and patient eligibility

About

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 in children 5 to 11 years of age, inclusive, with persistent asthma. The primary hypothesis of this study is that at least one dose of MF MDI BID increases lung function, defined as a significant increase in percent predicted FEV1, when compared to Placebo.

Enrollment: 583 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

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.
• 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 time frame of this study.
• Randomization into this study more than once.
• Direct association with either the administration of the this study or the study staff.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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583 participants in 5 patient groups, including a placebo group

MF MDI 50 mcg BID

Experimental group

Description:

Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks.

Treatment:

Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg

Drug: Placebo Dry Powder Inhaler (DPI)

MF MDI 100 mcg BID

Experimental group

Description:

Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.

Treatment:

Drug: Placebo Dry Powder Inhaler (DPI)

Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg

MF MDI 200 mcg BID

Experimental group

Description:

Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.

Treatment:

Drug: Placebo Dry Powder Inhaler (DPI)

Drug: Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg

MF DPI 100 mcg QD

Active Comparator group

Description:

Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.

Treatment:

Drug: Placebo Metered Dose Inhaler (MDI)

Drug: Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg

Placebo

Placebo Comparator group

Description:

Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.

Treatment:

Drug: Placebo Metered Dose Inhaler (MDI)

Drug: Placebo Dry Powder Inhaler (DPI)