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)

NCT01258803 | Completed Phase 2 Results

• 2 other identifiers: P06476MK-0887A-178
• Study Type: interventional
• Target: 92
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Asthma

Keywords

asthma; children; persistent

Outcome Measures

Primary Outcomes (1)

• Area Under the Curve From 0-12 Hours (AUC[0-12h]) of the Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) After a Single Dose of MF/F MDI With Spacer Compared to Placebo MDI Combined With or Without Spacer

  The AUC was standardized to liters by dividing the length of time for which measurements of FEV1 were included in the calculation of the AUC. Baseline was defined as the average of 2 pre-dose FEV1 measurements (taken 30 minutes before and immediately before dosing), which was subtracted from each of the serial FEV1 measurements over the 12-hour period. The AUC was calculated based on these changes from the baseline evaluations using the trapezoidal rule.

  Up to 12 hours postdose

Secondary Outcomes (7)

• AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose MF/F MDI Without Spacer Compared to Placebo MDI Combined With or Without Spacer

  Up to 12 hours postdose

• AUC(0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer Compared to MF/F MDI Without Spacer

  Up to 12 hours postdose

• Change From Baseline in FEV1 After a Single Dose of MF/F MDI With Spacer, MF/F MDI Without Spacer, F DPI or Placebo MDI Combined With or Without Spacer at 5 and 30 Minutes, 1, 2, 4, 8 and 12 Hours Postdose

  Baseline and 5 and 30 minutes, 1, 2, 4, 8 and 12 hours postdose

• AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F With Spacer Compared to F DPI

  Up to 12 hours postdose

• AUC (0-12h) of the Change From Baseline in FEV1 After a Single Dose of MF/F Without Spacer Compared to F DPI

  Up to 12 hours postdose

Study Arms (6)

Sequence 1

EXPERIMENTAL

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

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

Sequence 2

EXPERIMENTAL

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

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

Sequence 3

EXPERIMENTAL

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

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

Sequence 4

EXPERIMENTAL

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

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

Sequence 5

EXPERIMENTAL

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

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

Sequence 6

EXPERIMENTAL

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

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

Interventions

Formoterol Fumarate DPI DRUG

Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose

Also known as: SCH 045571, MK-5571, Foradil® Aerolizer®

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

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

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)

Also known as: SCH 418131, MK-0877A

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

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

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)

Also known as: SCH 418131, MK-0877A

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Placebo MDI with spacer DRUG

Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)

Sequence 1; Sequence 2; Sequence 3

Placebo MDI without spacer DRUG

Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)

Sequence 4; Sequence 5; Sequence 6

Mometasone Furoate DPI DRUG

Two inhalations of MF DPI 100 mcg administered as a single dose once daily at night. Used as maintenance therapy during screening and in between single doses of study drug.

Also known as: SCH 032088, MK-0887, Asmanex® Twisthaler®

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• Berger WE, Bensch GW, Weinstein SF, Skoner DP, Prenner BM, Shekar T, Nolte H, Teper AA. Bronchodilation with mometasone furoate/formoterol fumarate administered by metered-dose inhaler with and without a spacer in children with persistent asthma. Pediatr Pulmonol. 2014 May;49(5):441-50. doi: 10.1002/ppul.22850. Epub 2013 Sep 9.

  PMID: 24019197 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Mometasone Furoate; Metered Dose Inhalers

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Nebulizers and Vaporizers; Equipment and Supplies

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Study Officials

• Ariel Teper, MD

  Merck Sharp & Dohme LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2010
• First Posted: December 13, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 23, 2024
• Results First Posted: July 18, 2013

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share