Status:
COMPLETED
A Study of Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P04223)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
5-11 years
Phase:
PHASE2
Brief Summary
The primary objective of this study is to demonstrate the dose-related efficacy, by evaluating morning (AM) lung function at the end of the dosing interval (AM pre-dose percent predicted forced expira...
Eligibility Criteria
Inclusion
- Diagnosis of asthma of at least 6 months duration.
- Using an Inhaled corticosteroid (ICS), either alone or in combination with a long-acting beta-2 agonist (LABA), for at least 12 weeks prior to the Screening Visit and must have been on a stable asthma regimen for at least 2 weeks prior to the Screening Visit, must not have used oral glucocorticosteroids within 30 days of the Screening Visit.
Exclusion
- Treated in the emergency room for a severe asthma exacerbation requiring systemic glucocorticosteroid treatment, or hospitalization for management of airway obstruction within 3 months prior to the Screening Visit.
- History of ventilator support for respiratory failure secondary to asthma.
- Upper or lower respiratory tract infection (viral or bacterial) within the 2 weeks prior to Screening and Baseline Visits.
- History of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular, or other significant medical illness or disorder which, in the judgment of the investigator, could interfere with the study or require treatment that might interfere with the study. Specific examples include but are not limited to insulin-dependent diabetes, hypertension, active hepatitis, cardiovascular disease including hypertension, or conditions that may interfere with respiratory function such as, bronchiectasis, and cystic fibrosis. Other conditions that are well controlled and stable will not prohibit participation if deemed appropriate per the investigator's judgment.
- Inability to correctly use an oral MDI or a DPI.
- Participation in this study at another investigational site. Participation in a different investigational study at any site during the same time frame of this study.
- Randomization into this study more than once.
- Direct association with either the administration of the this study or the study staff.
Key Trial Info
Start Date :
January 25 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2015
Estimated Enrollment :
583 Patients enrolled
Trial Details
Trial ID
NCT01502371
Start Date
January 25 2012
End Date
January 29 2015
Last Update
June 17 2024
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