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)

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01615874
First received: June 7, 2012
Last updated: October 24, 2013
Last verified: October 2013

June 7, 2012
October 24, 2013
January 2013
September 2013   (final data collection date for primary outcome measure)
Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs [ Time Frame: Baseline (Day 1) and Day 42 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01615874 on ClinicalTrials.gov Archive Site
Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough) [ Time Frame: Baseline (Day 1) and Day 42 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Asthma
  • 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: MF/F MDI 50/5 mcg
    MF/F MDI 50/5 mcg, 2 inhalations BID
    Other Names:
    • SCH 418131
    • MK-0887A
    • DULERA®
  • Drug: MF/F MDI 100/5 mcg
    MF/F MDI 100/5 mcg, 2 inhalations BID
    Other Names:
    • SCH 418131
    • MK-0887A
    • DULERA®
  • Drug: BDP hydrofluoroalkane (HFA) 80 mcg
    BDP HFA 80 mcg, 2 inhalations BID
    Other Names:
    • BECONASE AQ®
    • QVAR®
  • 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
  • Experimental: MF/F MDI 50/10 mcg BID
    Interventions:
    • 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
  • Experimental: MF/F MDI 100/10 mcg BID
    Interventions:
    • Drug: MF/F MDI 50/5 mcg
    • Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI
    • Drug: Rescue medication: Prednisone/Prednisolone
  • Experimental: MF/F MDI 200/10 mcg BID
    Interventions:
    • Drug: MF/F MDI 100/5 mcg
    • Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI
    • Drug: Rescue medication: Prednisone/Prednisolone
  • Active Comparator: BDP HFA 160 mcg BID
    Interventions:
    • Drug: BDP hydrofluoroalkane (HFA) 80 mcg
    • Drug: Rescue medication: short-acting beta-2 agonist (SABA) MDI
    • Drug: Rescue medication: Prednisone/Prednisolone
  • Active Comparator: Montelukast 5 mg QD (4 mg QD for 5-year-olds)
    Interventions:
    • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
September 2013
September 2013   (final data collection date for primary outcome measure)

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
Both
5 Years to 11 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01615874
P05574, 2009-010108-27
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP