Advair Pediatric Once-Daily

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: FP 100mcg; Drug: FSC 100/50mcg; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00920959

SAS30021

Details and patient eligibility

About

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.

Enrollment: 908 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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908 participants in 3 patient groups

Fluticasone propionate/salmeterol combination

Experimental group

Description:

study drug

Treatment:

Drug: FSC 100/50mcg

Fluticasone propionate

Experimental group

Description:

study drug

Treatment:

Drug: FP 100mcg

Placebo

Experimental group

Description:

placebo

Treatment:

Drug: Placebo