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This study has been withdrawn prior to enrollment.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

ClinicalTrials.gov Identifier:

NCT01615874

First received: June 7, 2012

Last updated: November 13, 2012

Last verified: November 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 7, 2012
Last Updated Date	November 13, 2012
Start Date ^ICMJE	January 2013
Estimated Primary Completion Date	September 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 8, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01615874 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: June 8, 2012)	Change from Baseline in Plasma Cortisol Trough Concentration (Ctrough) [ Time Frame: Baseline (Day 1) and Day 42 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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 ^ICMJE	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)
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Asthma
Intervention ^ICMJE	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
Study Arm (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Enrollment ^ICMJE	0
Estimated Completion Date	September 2013
Estimated Primary Completion Date	September 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	5 Years to 11 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01615874
Other Study ID Numbers ^ICMJE	P05574, 2009-010108-27
Has Data Monitoring Committee	No
Responsible Party	Merck
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	November 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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