A Study In Pediatric Subjects With Asthma Using ADVAIR HF... | NCT00400608

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

NCT00400608

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Oct 28, 2016Estimated

Enrollment

28Actual

Phase

Phase 4

Conditions

Asthma

Interventions

ADVAIR HFA
ADVAIR DISKUS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2006

Primary Completion Date

Not provided

Completion Date

Feb 2007Actual

First Submitted Date

Nov 15, 2006

First Submission Date that Met QC Criteria

Nov 15, 2006

First Posted Date

Nov 17, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2016

Last Update Posted Date

Oct 28, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

28Actual

Name	Type	Description	Arm Group Labels	Other Names
ADVAIR HFA	Drug
ADVAIR DISKUS	Drug			ADVAIR HFA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PD of Fluticasone as measured by serum cortisol followed by doses of ADVAIR HFA and ADVAIR DISKUS		3 Weeks

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Huntington Beach	California	92647	United States
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
	Background	This study has not been published in the scientific literature.

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

ID	Term
D000068299	Salmeterol Xinafoate
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols