Study of the Effect of Mometasone Furoate/Formoterol (MF/F), Montelukast and Beclomethasone Dipropionate (BDP) on Plasma Cortisol Levels of Children 5-11 Years Old With Persistent Asthma (P05574)

A Six-week Evaluator-Blind, Randomized, Active-Controlled Evaluation of the Effects of Three Doses of Mometasone Furoate/Formoterol Fumarate (MF/F) Metered Dose Inhaler (MDI), Montelukast, and Beclomethasone Dipropionate (BDP HFA) on the HPA Axis in Asthmatic Children 5 to 11 Years of Age (Protocol No. P05574/PN158)

The purpose of this study is to assess the effect of one of five possible study medications used in the treatment of asthma on blood plasma cortisol levels in children aged 5-11 years with persistent asthma.

Study Overview

• Status: Withdrawn
• Conditions: Asthma
• Intervention / Treatment: Drug: MF/F Metered Dose Inhaler (MDI) 25/5 mcg; Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI; Drug: Rescue medication: Prednisone/Prednisolone; Drug: MF/F MDI 50/5 mcg; Drug: MF/F MDI 100/5 mcg; Drug: BDP hydrofluoroalkane (HFA) 80 mcg; Drug: Montelukast tablets 5 mg (4 mg for children 5 years of age)

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 11 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosis of persistent asthma of ≥6 months duration
• body weight ≥18 kg
• able to discontinue prescribed inhaled corticosteroid (ICS) or ICS combined with long-acting beta-agonist (LABA) before starting study medication
• use of a low or medium daily dose of ICS (either alone or in combination with a LABA) with no use of oral corticosteroids within 3 months prior to Screening Visit
• stable asthma regimen (daily dose unchanged) for ≥2 weeks prior to Screening Visit
• documented positive responsiveness to bronchodilators
• ability to use a peak flow meter correctly and to perform spirometry and PEF measurements
• ability to use an inhaler correctly
• consent/assent for the trial and for pharmacogenetic testing (Note: If unwilling to consent/assent for pharmacogenetic testing, inclusion in the study is still allowed, but no pharmacogenetic samples will be obtained.)

Exclusion Criteria:

• use of a high dose of ICS for ≥30 days within 6 months prior to Screening Visit
• treatment in the emergency room (for a severe asthma exacerbation requiring systemic corticosteroid treatment) or hospitalization for management of airway obstruction within 3 months prior to Screening Visit
• ever required ventilator support for respiratory failure secondary to asthma
• upper or lower respiratory tract infection (viral or bacterial) within 2 weeks prior to Screening Visit
• clinically significant abnormal vital sign
• evidence of oropharyngeal candidiasis
• history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder that may interfere with study participation. Specific examples include but are not limited to insulin-dependent diabetes, active hepatitis, cardiovascular disease including hypertension, or conditions that may interfere with respiratory function such as, bronchiectasis, and cystic fibrosis
• allergy to or intolerance of corticoids, beta-2 agonists, montelukast or any of the inactive ingredients in the medications used in this study
• participation in this same study at another study site
• previous randomization into this study
• participation in another investigational study for the duration of this study
• use of any investigational drug within one month prior to Screening Visit
• previous participation in a study with MF/F or montelukast
• direct association with or family member of one of the investigators or study staff
• sibling of a participant in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MF/F MDI 200/10 mcg BID	Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI; albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed; Drug: Rescue medication: Prednisone/Prednisolone; Prednisone/Prednisolone for rescue medication, taken as directed; Drug: MF/F MDI 100/5 mcg; MF/F MDI 100/5 mcg, 2 inhalations BID; Other Names: SCH 418131; MK-0887A; DULERA®
EXPERIMENTAL: MF/F MDI 50/10 mcg BID	Drug: MF/F Metered Dose Inhaler (MDI) 25/5 mcg; MF/F MDI 25/5 mcg, 2 inhalations twice a day (BID); Other Names: SCH 418131; MK-0887A; DULERA®; Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI; albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed; Drug: Rescue medication: Prednisone/Prednisolone; Prednisone/Prednisolone for rescue medication, taken as directed
EXPERIMENTAL: MF/F MDI 100/10 mcg BID	Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI; albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed; Drug: Rescue medication: Prednisone/Prednisolone; Prednisone/Prednisolone for rescue medication, taken as directed; Drug: MF/F MDI 50/5 mcg; MF/F MDI 50/5 mcg, 2 inhalations BID; Other Names: SCH 418131; MK-0887A; DULERA®
ACTIVE_COMPARATOR: BDP HFA 160 mcg BID	Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI; albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed; Drug: Rescue medication: Prednisone/Prednisolone; Prednisone/Prednisolone for rescue medication, taken as directed; Drug: BDP hydrofluoroalkane (HFA) 80 mcg; BDP HFA 80 mcg, 2 inhalations BID; Other Names: QVAR®; BECONASE AQ®
ACTIVE_COMPARATOR: Montelukast 5 mg QD (4 mg QD for 5-year-olds)	Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI; albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed; Drug: Rescue medication: Prednisone/Prednisolone; Prednisone/Prednisolone for rescue medication, taken as directed; Drug: Montelukast tablets 5 mg (4 mg for children 5 years of age); Montelukast chewable tablets 5 mg once daily (QD) for children 6-11 years of age OR Montelukast chewable tablets 4 mg QD for children 5 years of age; Other Names: MK-0476; SINGULAIR®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs	Baseline (Day 1) and Day 42

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough)	Baseline (Day 1) and Day 42

Collaborators and Investigators

• Sponsor: Organon and Co

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ANTICIPATED): September 1, 2013
• Study Completion (ANTICIPATED): September 1, 2013

Study Registration Dates

• First Submitted: June 7, 2012
• First Submitted That Met QC Criteria: June 8, 2012
• First Posted (ESTIMATE): June 11, 2012

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Prednisolone; Montelukast; Prednisone; Mometasone Furoate, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: P05574; 2009-010108-27 (EUDRACT_NUMBER)