Status:
COMPLETED
A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)
Lead Sponsor:
Organon and Co
Conditions:
Asthma
Eligibility:
All Genders
5-11 years
Phase:
PHASE2
Brief Summary
A study to compare the bronchodilatory effect of a single dose of Mometasone Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and without an AeroChamber Plus® w...
Eligibility Criteria
Inclusion
- Must have a diagnosis of asthma of at least 6 months duration
- Must have taken an Inhaled Corticosteroid (\[ICS\]; alone or in combination with a long-acting beta-2 Agonist \[LABA\]) for at least 3 months prior to the Screening Visit and must have been on a stable daily dose for at least 2 weeks prior to the Screening Visit
- FEV1 must be at least 70% predicted after all restricted medications have been withheld for the appropriate intervals
- Must demonstrate an increase in absolute FEV1 of at least 12% within 30 minutes after administration of 360 mcg albuterol (4 inhalations x 90 mcg, ex-actuator) or of nebulized albuterol (2.5 mg), if confirmed as standard office practice
Exclusion
- Has been treated in the emergency room for a severe asthma exacerbation requiring systemic glucocorticosteroid treatment, or hospitalized for management of airway obstruction within 3 months prior to the Screening Visit
- Has required ventilator support for respiratory failure secondary to asthma
- Demonstrates a decrease in absolute FEV1 of \>20% at any time from the Screening Visit up to and including the Baseline Visit
- Requires the use of greater than 8 inhalations per day of short-acting beta-2 agonists (SABA) MDI, or 2 or more nebulized treatments per day of 2.5 mg SABA on any 2 consecutive days from the Screening Visit up to and including the Baseline Visit
- Experiences a clinical deterioration in asthma that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded asthma medication (including oral or other systemic corticosteroids, but allowing SABA) as judged by the investigator, at any time from the Screening Visit up to and including the Baseline Visit
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01258803
Start Date
December 1 2010
End Date
October 1 2011
Last Update
May 23 2024
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