Study of the Effect of Mometasone Furoate/Formoterol (MF/F), Montelukast and Beclomethasone Dipro… (NCT01615874) | Clinical Trial Compass
WithdrawnPhase 2
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)
0Started 2013-01
Plain-language 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.
Who can participate
Age range5 Years – 11 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…
What they're measuring
1
Change from Baseline in Plasma Cortisol Area Under the Curve (AUC) 0-24 hrs