Advair Pediatric Once-Daily

• Status: Completed
• Trial end date: 2004-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Salmeterol Xinafoate

Criteria

Inclusion Criteria:

• Out-patients

• Asthma diagnosis

• Reversibility

• Short-acting beta-agonist or asthma controlled medication use

Exclusion Criteria:

• Life-threatening asthma

• Specified asthma medications

• Chickenpox

• Drug allergy

• Respiratory infections

• Tobacco use

• Clinical laboratory abnormalities

• Ophthalmologic conditions

• Investigation medications

• Affiliation with investigator site