A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)

Organon

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer; Drug: Formoterol Fumarate DPI; Drug: Placebo MDI with spacer; Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer; Drug: Mometasone Furoate DPI; Drug: Placebo MDI without spacer

Study type: Interventional

Funder types: Industry

Identifiers

NCT01258803

P06476

MK-0887A-178 (Other Identifier)

Details and patient eligibility

About

A study to compare the bronchodilatory effect of a single dose of Mometasone Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and without an AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber (spacer) versus Placebo MDI (combined with and without spacer) and formoterol fumarate (F) dry powder inhaler (DPI). Participants were randomly assigned to 1 of 6 treatment sequences and each participant was to receive a single dose of each of 4 treatments in each period. Each treatment period was separated by a 5 to 7 day washout period. It assumed that a single dose MF/F MDI 100/10 microgram (mcg) delivered with a spacer would produce bronchodilation, defined as a significant increase in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours (AUC[0-12 hr]) when compared to placebo.

Enrollment: 92 patients

Sex: All

Ages: 5 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must have a diagnosis of asthma of at least 6 months duration
• Must have taken an Inhaled Corticosteroid ([ICS]; alone or in combination with a long-acting beta-2 Agonist [LABA]) for at least 3 months prior to the Screening Visit and must have been on a stable daily dose for at least 2 weeks prior to the Screening Visit
• FEV1 must be at least 70% predicted after all restricted medications have been withheld for the appropriate intervals
• Must demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of 360 mcg albuterol (4 inhalations x 90 mcg, ex-actuator) or of nebulized albuterol (2.5 mg), if confirmed as standard office practice

Exclusion criteria

• Has been treated in the emergency room for a severe asthma exacerbation requiring systemic glucocorticosteroid treatment, or hospitalized for management of airway obstruction within 3 months prior to the Screening Visit
• Has required ventilator support for respiratory failure secondary to asthma
• Demonstrates a decrease in absolute FEV1 of >20% at any time from the Screening Visit up to and including the Baseline Visit
• Requires the use of greater than 8 inhalations per day of short-acting beta-2 agonists (SABA) MDI, or 2 or more nebulized treatments per day of 2.5 mg SABA on any 2 consecutive days from the Screening Visit up to and including the Baseline Visit
• Experiences a clinical deterioration in asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids, but allowing SABA) as judged by the investigator, at any time from the Screening Visit up to and including the Baseline Visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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92 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Treatment Period 1: Placebo MDI with spacer; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: F DPI

Treatment:

Drug: Mometasone Furoate DPI

Drug: Placebo MDI with spacer

Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer

Drug: Formoterol Fumarate DPI

Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer

Sequence 2

Experimental group

Description:

Treatment Period 1: F DPI; Treatment Period 2: MF/F MDI without spacer; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI with spacer

Treatment:

Drug: Mometasone Furoate DPI

Drug: Placebo MDI with spacer

Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer

Drug: Formoterol Fumarate DPI

Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer

Sequence 3

Experimental group

Description:

Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: Placebo MDI with spacer; Treatment Period 4: MF/F MDI with spacer

Treatment:

Drug: Mometasone Furoate DPI

Drug: Placebo MDI with spacer

Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer

Drug: Formoterol Fumarate DPI

Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer

Sequence 4

Experimental group

Description:

Treatment Period 1: Placebo MDI without spacer; Treatment Period 2: MF/F MDI with spacer; Treatment Period 3: F DPI; Treatment Period 4: MF/F MDI without spacer

Treatment:

Drug: Mometasone Furoate DPI

Drug: Placebo MDI without spacer

Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer

Drug: Formoterol Fumarate DPI

Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer

Sequence 5

Experimental group

Description:

Treatment Period 1: MF/F MDI without spacer; Treatment Period 2: F DPI; Treatment Period 3: MF/F MDI with spacer; Treatment Period 4: Placebo MDI without spacer

Treatment:

Drug: Mometasone Furoate DPI

Drug: Placebo MDI without spacer

Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer

Drug: Formoterol Fumarate DPI

Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer

Sequence 6

Experimental group

Description:

Treatment Period 1: MF/F MDI with spacer; Treatment Period 2: Placebo MDI without spacer; Treatment Period 3: MF/F MDI without spacer; Treatment Period 4: F DPI

Treatment:

Drug: Mometasone Furoate DPI

Drug: Placebo MDI without spacer

Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer

Drug: Formoterol Fumarate DPI

Drug: Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer