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)
2 other identifiers
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2013
Shorter than P25 for phase_2 asthma
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2012
CompletedFirst Posted
Study publicly available on registry
June 11, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedFebruary 16, 2022
February 1, 2022
8 months
June 7, 2012
February 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs
Baseline (Day 1) and Day 42
Secondary Outcomes (1)
Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough)
Baseline (Day 1) and Day 42
Study Arms (5)
MF/F MDI 50/10 mcg BID
EXPERIMENTALMF/F MDI 100/10 mcg BID
EXPERIMENTALMF/F MDI 200/10 mcg BID
EXPERIMENTALBDP HFA 160 mcg BID
ACTIVE COMPARATORMontelukast 5 mg QD (4 mg QD for 5-year-olds)
ACTIVE COMPARATORInterventions
MF/F MDI 25/5 mcg, 2 inhalations twice a day (BID)
MF/F MDI 50/5 mcg, 2 inhalations BID
MF/F MDI 100/5 mcg, 2 inhalations BID
BDP HFA 80 mcg, 2 inhalations BID
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
albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed
Prednisone/Prednisolone for rescue medication, taken as directed
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2012
First Posted
June 11, 2012
Study Start
January 1, 2013
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
February 16, 2022
Record last verified: 2022-02