Comparator study in children investigating whole body exposure to Advair Inhalation alone or via the Aerochamber Plus Spacer or via Advair Diskus.

Phase 1

• Conditions: Asthma; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2015-004866-27-Outside-EU/EEA
• Lead Sponsor: GlaxoSmithKline Research & Development

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-03
• Last Update Posted: 8 August 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Male and pre-menarchial female subjects with mild asthma (PEF > 75% predicted) aged 4 - 11 years are eligible for this study. Pre-menarchial females are defined as any female who has yet to begin menses and is considered Tanner Stage 2 or less; any female who begins menstruation during the course of the study will be withdrawn.
2. Apart from asthma(as defined by GINA, 2005), subjects should be healthy and suffer from no other significant medical conditions.
3. Subjects must weigh at least 11 kg and have a BMI of 14-24 kg/m2 for inclusion in this study.
4. Subjects and/or parents must demonstrate ability to accept and effectively use the MDI, Aerochamber Plus Spacer and DISKUS devices using the demonstration kits provided to the site.
Are the trial subjects under 18? yes
Number of subjects for this age range: 30
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any clinically relevant abnormality identified on the screening medical assessment
2. Any medical condition or circumstance making the volunteer unsuitable for participation in the study
3. Subjects should not be on a long-acting beta-agonist and asthma control should be with regular or intermittent non-steroidal asthma medication, such as short-acting
beta-agonist as required or montelukast, for at least three months prior to entry in to the study.
• Inhaled corticosteroids will be excluded for 6 weeks prior to the Screening Visit and throughout the study until study discharge at Session 2. Investigators should not discontinue ICS therapy if there is a significant possibility that this will result in deterioration in asthma control
• Topical corticosteroids equivalent to >1% hydrocortisone cream or ointment at any time from Screening Visit through discharge at the end of Session 2
4. A subject has been using Corticosteriods in any of the delivery systems as indicated below:
• Oral or parenteral corticosteroids used within 10 weeks prior to the Screening Visit or during the study until study discharge in Session 2 or has used more than 2 courses during 6 months prior to the Screening Visit
• Intranasal corticosteroids within 2 weeks before Screening Visit and during the study until study discharge in Session 2

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The purpose of this study was to compare the systemic exposure and pharmacodynamics of therapeutic<br>doses of Advair HFA;Secondary Objective: To assess the systemic exposure of FP and salmeterol following administration of 2 X ADVAIR HFA 45/21, 2 X ADVAIR HFA 45/21 with Aerochamber Plus Spacer and ADVAIR DISKUS 100/50;Primary end point(s): Serum cortisol weighted mean(0-12h) and Cmin (0-12h) (FP PD);Timepoint(s) of evaluation of this end point: Three Weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - FP and SALM Cmaxss, AUClast and tmaxss<br>- Heart rate, systolic BP, diastolic BP, QTc (B) and QTc (F) weighted mean(0-9h)<br>and peak response, diastolic BP trough(0-9h)<br>;Timepoint(s) of evaluation of this end point: Three Weeks