Clareo Health | 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)
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)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Organon and Co
Age
5–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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
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.)
You may not be 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
