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)(MK-0887A-178-0)
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Purpose
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 will be randomly assigned to 1 of 6 treatment sequences and each participant will receive a single dose of each of 4 treatments in each period. Each treatment period is 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 will 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Formoterol Fumarate DPI Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) without a spacer Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) with spacer Drug: Placebo MDI with spacer Drug: Placebo MDI without spacer |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Evaluator-Blind, Crossover, Single Dose Study of the Bronchodilator Effect of Formoterol Fumarate in Combination With Mometasone Furoate Metered Dose Inhaler Delivered With and Without a Spacer Versus Placebo and Foradil® Aerolizer® in Children With Persistent Asthma (P06476) |
- Comparison of the area under the curve from 0 to 12 hours (AUC[0-12]) of the change from baseline in forced expiratory volume in 1 second (FEV1) after a single dose MF/F MDI 100/10 mcg with spacer versus placebo MDI (with and without spacer evaluations) [ Time Frame: Baseline and up to 12 hours ] [ Designated as safety issue: No ]
- Comparison of AUC(0-12) of the change from baseline in FEV1 after a single dose MF/F MDI 100/10 mcg without spacer versus placebo MDI (with and without spacer evaluations) [ Time Frame: Baseline and up to 12 hours ] [ Designated as safety issue: No ]
- Comparison of AUC(0-12) of the change from baseline in FEV1 after a single dose of MF/F MDI 100/10 mcg with a spacer versus MF/F MDI 100/10 mcg without a spacer [ Time Frame: Baseline and up to 12 hours ] [ Designated as safety issue: No ]
| Enrollment: | 92 |
| Study Start Date: | December 2010 |
| Study Completion Date: | October 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Sequence 1
Placebo MDI with spacer; MF/F MDI without spacer; MF/F MDI with spacer; F DPI
|
Drug: Formoterol Fumarate DPI
Single dose of Formoterol Fumarate DPI 10 mcg
Other Name: Foradil® Aerolizer®
Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) without a spacer
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
Other Name: SCH 418131
Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) with spacer
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
Other Name: SCH 418131
Drug: Placebo MDI with spacer
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
|
Experimental: Sequence 2
F DPI; MF/F MDI without spacer; MF/F MDI with spacer; Placebo MDI with spacer
|
Drug: Formoterol Fumarate DPI
Single dose of Formoterol Fumarate DPI 10 mcg
Other Name: Foradil® Aerolizer®
Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) without a spacer
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
Other Name: SCH 418131
Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) with spacer
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
Other Name: SCH 418131
Drug: Placebo MDI with spacer
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
|
Experimental: Sequence 3
MF/F MDI without spacer; F DPI; Placebo MDI with spacer; MF/F MDI with spacer
|
Drug: Formoterol Fumarate DPI
Single dose of Formoterol Fumarate DPI 10 mcg
Other Name: Foradil® Aerolizer®
Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) without a spacer
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
Other Name: SCH 418131
Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) with spacer
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
Other Name: SCH 418131
Drug: Placebo MDI with spacer
Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
|
Experimental: Sequence 4
Placebo MDI without spacer; MF/F MDI with spacer; F DPI; MF/F MDI without spacer
|
Drug: Formoterol Fumarate DPI
Single dose of Formoterol Fumarate DPI 10 mcg
Other Name: Foradil® Aerolizer®
Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) without a spacer
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
Other Name: SCH 418131
Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) with spacer
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
Other Name: SCH 418131
Drug: Placebo MDI without spacer
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
|
Experimental: Sequence 5
MF/F MDI without spacer; F DPI; MF/F MDI with spacer; Placebo MDI without spacer
|
Drug: Formoterol Fumarate DPI
Single dose of Formoterol Fumarate DPI 10 mcg
Other Name: Foradil® Aerolizer®
Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) without a spacer
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
Other Name: SCH 418131
Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) with spacer
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
Other Name: SCH 418131
Drug: Placebo MDI without spacer
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
|
Experimental: Sequence 6
MF/F MDI with spacer; Placebo MDI without spacer; MF/F MDI without spacer; F DPI
|
Drug: Formoterol Fumarate DPI
Single dose of Formoterol Fumarate DPI 10 mcg
Other Name: Foradil® Aerolizer®
Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) without a spacer
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
Other Name: SCH 418131
Drug: Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg (ex-actuator) with spacer
Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
Other Name: SCH 418131
Drug: Placebo MDI without spacer
Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
|
Eligibility| Ages Eligible for Study: | 5 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT01258803 History of Changes |
| Other Study ID Numbers: | P06476, MK-0887A-178-0 |
| Study First Received: | December 9, 2010 |
| Last Updated: | November 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Schering-Plough:
|
asthma children persistent |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Bronchodilator Agents Formoterol Mometasone furoate Autonomic Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013