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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400608
• Other study ID #: SAS105519
• Status: Completed
• Phase: Phase 4
• First received: November 15, 2006
• Last updated: October 26, 2016
• Start date: October 2006
• Est. completion date: February 2007

Study information

• Verified date: October 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 11 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• ADVAIR HFA

• ADVAIR DISKUS

Locations

Country	Name	City	State
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Medford	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (1)

This study has not been published in the scientific literature.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PD of Fluticasone as measured by serum cortisol followed by doses of ADVAIR HFA and ADVAIR DISKUS		3 Weeks
Secondary	To assess the exposure of FP and Salmeterol following the doses of ADVAIR HFA and ADVAIR DISKUS as well as assessing safety measurements based on adverse event reporting		3 Weeks

External Links

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