A Study In Pediatric Subjects With Asthma Using ADVAIR HFA, ADVAIR HFA With Spacer, And ADVAIR DISKUS

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: ADVAIR DISKUS; Drug: ADVAIR HFA

Study type: Interventional

Funder types: Industry

Identifiers

NCT00400608

SAS105519

Details and patient eligibility

About

Collect PK/PD data for this age group to compare ADVAIR DISKUS with ADVAIR HFA

Full description

A repeat-dose open label randomized incomplete block design in pediatric subjects with asthma, ages 4-11 years, to compare systemic exposure and pharmacodynamics of fluticasone propionate and salmeterol following ADVAIR HFA 45/21mcg(2 inhalations), ADVAIR HFA 45/21mcg(2 inhalations) with Aerochamber Plus Spacer and ADVAIR DISKUS 100/50 twice daily

Enrollment: 28 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with mild asthma
• No significant medical conditions at screen
• Weigh at least 20 kg

Exclusion criteria

• No clinical abnormalities at screen visit
• Asthma control at least 3 months prior with anti-steroidal medication only

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)