Status:
COMPLETED
Advair Pediatric Once-Daily
Lead Sponsor:
GlaxoSmithKline
Conditions:
Asthma
Eligibility:
All Genders
4-11 years
Phase:
PHASE3
Brief Summary
To demonstrate if once-daily dosing of ADVAIR 100/50 once-daily has superior efficacy and comparable safety compared with FP 100mcg once-daily in pediatric subjects 4 to 11 years of age with asthma.
Eligibility Criteria
Inclusion
- Out-patients
- Asthma diagnosis
- Reversibility
- Short-acting beta-agonist or asthma controlled medication use
Exclusion
- Life-threatening asthma
- Specified asthma medications
- Chickenpox
- Drug allergy
- Respiratory infections
- Tobacco use
- Clinical laboratory abnormalities
- Ophthalmologic conditions
- Investigation medications
- Affiliation with investigator site
Key Trial Info
Start Date :
November 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2004
Estimated Enrollment :
908 Patients enrolled
Trial Details
Trial ID
NCT00920959
Start Date
November 1 2001
End Date
January 1 2004
Last Update
September 15 2016
Active Locations (149)
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1
GSK Investigational Site
Ozark, Alabama, United States, 36360
2
GSK Investigational Site
Tucson, Arizona, United States, 85716
3
GSK Investigational Site
Tucson, Arizona, United States, 85746
4
GSK Investigational Site
Little Rock, Arkansas, United States, 72205