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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Schering-Plough
ClinicalTrials.gov Identifier:
NCT01258803
First received: December 9, 2010
Last updated: November 21, 2011
Last verified: November 2011
  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)

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01258803

Sponsors and Collaborators
Schering-Plough
Investigators
Study Chair: Ariel Teper, MD Merck
  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