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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)

Primary Purpose

Asthma

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MF/F Metered Dose Inhaler (MDI) 25/5 mcg
MF/F MDI 50/5 mcg
MF/F MDI 100/5 mcg
BDP hydrofluoroalkane (HFA) 80 mcg
Montelukast tablets 5 mg (4 mg for children 5 years of age)
Rescue medication: short-acting beta-2 agonist (SABA) MDI
Rescue medication: Prednisone/Prednisolone
Sponsored by
Organon and Co
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

5 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    MF/F MDI 50/10 mcg BID

    MF/F MDI 100/10 mcg BID

    MF/F MDI 200/10 mcg BID

    BDP HFA 160 mcg BID

    Montelukast 5 mg QD (4 mg QD for 5-year-olds)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs

    Secondary Outcome Measures

    Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough)

    Full Information

    First Posted
    June 7, 2012
    Last Updated
    February 7, 2022
    Sponsor
    Organon and Co
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01615874
    Brief Title
    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)
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    September 2013 (Anticipated)
    Study Completion Date
    September 2013 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Organon and Co

    4. Oversight

    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MF/F MDI 50/10 mcg BID
    Arm Type
    Experimental
    Arm Title
    MF/F MDI 100/10 mcg BID
    Arm Type
    Experimental
    Arm Title
    MF/F MDI 200/10 mcg BID
    Arm Type
    Experimental
    Arm Title
    BDP HFA 160 mcg BID
    Arm Type
    Active Comparator
    Arm Title
    Montelukast 5 mg QD (4 mg QD for 5-year-olds)
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    MF/F Metered Dose Inhaler (MDI) 25/5 mcg
    Other Intervention Name(s)
    SCH 418131, MK-0887A, DULERA®
    Intervention Description
    MF/F MDI 25/5 mcg, 2 inhalations twice a day (BID)
    Intervention Type
    Drug
    Intervention Name(s)
    MF/F MDI 50/5 mcg
    Other Intervention Name(s)
    SCH 418131, MK-0887A, DULERA®
    Intervention Description
    MF/F MDI 50/5 mcg, 2 inhalations BID
    Intervention Type
    Drug
    Intervention Name(s)
    MF/F MDI 100/5 mcg
    Other Intervention Name(s)
    SCH 418131, MK-0887A, DULERA®
    Intervention Description
    MF/F MDI 100/5 mcg, 2 inhalations BID
    Intervention Type
    Drug
    Intervention Name(s)
    BDP hydrofluoroalkane (HFA) 80 mcg
    Other Intervention Name(s)
    BECONASE AQ®, QVAR®
    Intervention Description
    BDP HFA 80 mcg, 2 inhalations BID
    Intervention Type
    Drug
    Intervention Name(s)
    Montelukast tablets 5 mg (4 mg for children 5 years of age)
    Other Intervention Name(s)
    MK-0476, SINGULAIR®
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Rescue medication: short-acting beta-2 agonist (SABA) MDI
    Intervention Description
    albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed
    Intervention Type
    Drug
    Intervention Name(s)
    Rescue medication: Prednisone/Prednisolone
    Intervention Description
    Prednisone/Prednisolone for rescue medication, taken as directed
    Primary Outcome Measure Information:
    Title
    Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs
    Time Frame
    Baseline (Day 1) and Day 42
    Secondary Outcome Measure Information:
    Title
    Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough)
    Time Frame
    Baseline (Day 1) and Day 42

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    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)

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