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

NCT ID: NCT00400608

Last Updated: 2016-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2007-02-28

Brief Summary

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

Detailed Description

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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

Conditions

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Asthma

Keywords

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pediatrics ADVAIR Inhaler Asthma ADVAIR DISKUS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ADVAIR HFA

Intervention Type DRUG

ADVAIR DISKUS

Intervention Type DRUG

Other Intervention Names

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ADVAIR HFA

Eligibility Criteria

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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
Minimum Eligible Age

4 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Huntington Beach, California, United States

Site Status

GSK Investigational Site

Long Beach, California, United States

Site Status

GSK Investigational Site

Medford, Oregon, United States

Site Status

Countries

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United States

References

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This study has not been published in the scientific literature.

Reference Type BACKGROUND

Study Documents

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Document Type: Clinical Study Report

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Informed Consent Form

View Document

Document Type: Annotated Case Report Form

View Document

Document Type: Dataset Specification

View Document

Document Type: Study Protocol

View Document

Related Links

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https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

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SAS105519

Identifier Type: -

Identifier Source: org_study_id