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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)

Sponsor
Organon and Co (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01615874
Collaborator
(none)
0
Enrollment
5
Arms
8
Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: MF/F Metered Dose Inhaler (MDI) 25/5 mcg
  • 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)
  • Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI
  • Drug: Rescue medication: Prednisone/Prednisolone
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Sep 1, 2013
Anticipated Study Completion Date :
Sep 1, 2013

Arms and Interventions

Arm Intervention/Treatment
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: MF/F MDI 50/5 mcg
    MF/F MDI 50/5 mcg, 2 inhalations 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 200/10 mcg BID

    Drug: MF/F MDI 100/5 mcg
    MF/F MDI 100/5 mcg, 2 inhalations 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
    Active Comparator: BDP HFA 160 mcg BID

    Drug: BDP hydrofluoroalkane (HFA) 80 mcg
    BDP HFA 80 mcg, 2 inhalations BID
    Other Names:
  • BECONASE AQ®
  • QVAR®

    • 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
    Active Comparator: Montelukast 5 mg QD (4 mg QD for 5-year-olds)

    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®

    • 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

    Outcome Measures

    Primary Outcome Measures

    1. Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs [Baseline (Day 1) and Day 42]

    Secondary Outcome Measures

    1. Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough) [Baseline (Day 1) and Day 42]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 11 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Organon and Co

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Organon and Co
    ClinicalTrials.gov Identifier:
    NCT01615874
    Other Study ID Numbers:
    • P05574
    • 2009-010108-27
    First Posted:
    Jun 11, 2012
    Last Update Posted:
    Feb 16, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:
    Asthma
    Prednisone
    Prednisolone
    Montelukast
    Mometasone Furoate, Formoterol Fumarate Drug Combination

    Study Results

    No Results Posted as of Feb 16, 2022