Status:
COMPLETED
A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
6-11 years
Phase:
PHASE2
Brief Summary
This purpose of the study is to investigate the bronchodilating effects of 3 different dosages of formoterol given in combination with budesonide as Symbicort pMDI.
Detailed Description
A Phase 2, randomized, blinded, 5-period cross-over, placebo and active controlled, multicenter, dose-finding study comparing single doses of formoterol 2.25 µg, 4.5 µg, and 9 µg delivered via Symbico...
Eligibility Criteria
Inclusion
- Has a documented clinical diagnosis of asthma for at least 6 months prior to Visit 1
- Has a FEV1 measured at least 6 hours after the last dose of inhaled, short-acting β2-agonist (SABA) and at least 48 hours after the last dose of inhaled long-acting β2-agonist of =60% and =85% of predicted normal.
- Demonstrated reversibility of FEV1 of =15% from pre short acting beta agonist level within 15 to 30 minutes after administration of a standard dose of short acting beta agonist
Exclusion
- Has been hospitalized for \>24 hours at least once or required emergency treatment or urgent care visit more than once for an asthma-related condition during the 6 months prior to Visit 1
- Has required treatment with systemic corticosteroids (eg, oral, parenteral, or rectal) for any reason within the 12 weeks prior to Visit 1.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT01136655
Start Date
September 1 2010
End Date
December 1 2011
Last Update
October 31 2013
Active Locations (34)
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1
Research Site
Huntington, California, United States
2
Research Site
Long Beach, California, United States
3
Research Site
Mission Viejo, California, United States
4
Research Site
Orange, California, United States