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Advair Pediatric Once-Daily

A Stratified, Randomized, Double-blind, Placebo-controlled, Parallel-group, 12 Week Trial Evaluating the Safety and Efficacy of Fluticasone Propionate/Salmeterol DISKUS Combination Product 100/50mcg Once Daily Versus Fluticasone Propionate DISKUS 100mcg Once Daily and Placebo in Symptomatic Pediatric Subjects (4-11 Years) With Asthma

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00920959
Enrollment
908
Registered
2009-06-15
Start date
2001-11-30
Completion date
2004-01-31
Last updated
2016-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

DRUGFSC 100/50mcg

Once-daily dosing

DRUGPlacebo

Once-daily dosing

DRUGFP 100mcg

Once-daily dosing

Sponsors

GlaxoSmithKline
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change from baseline at endpoint in daily PM PEF12 weeks

Secondary

MeasureTime frame
Various pulmonary function endpoints12 weeks

Countries

Argentina, Chile, Peru, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026