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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Asthma
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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough) [ Time Frame: Baseline (Day 1) and Day 42 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01615874     History of Changes
Other Study ID Numbers: P05574, 2009-010108-27
Study First Received: June 7, 2012
Last Updated: October 24, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methylprednisolone acetate
Prednisolone acetate
Mometasone furoate
Beclomethasone
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisone
Prednisolone hemisuccinate
Prednisolone phosphate
Formoterol
Montelukast
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 28, 2014