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This study has been withdrawn prior to enrollment.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:
Merck
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01615874
First received: June 7, 2012
Last updated: November 13, 2012
Last verified: November 2012
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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:
Drug Information available for:
Prednisolone
Prednisolone acetate
Prednisone
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
Beclomethasone dipropionate
Formoterol fumarate
Formoterol
Beclomethasone dipropionate monohydrate
Mometasone furoate
Mometasone furoate monohydrate
Montelukast sodium
Montelukast
Arformoterol Tartrate
Dulera
U.S. FDA Resources
Further study details as provided by Merck:
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:
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:
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:
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:
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:
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
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Merck |
| ClinicalTrials.gov Identifier: | NCT01615874 History of Changes |
| Other Study ID Numbers: | P05574, 2009-010108-27 |
| Study First Received: | June 7, 2012 |
| Last Updated: | November 13, 2012 |
| 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 May 16, 2013