Study In Airway Physiology In Children SERETIDE DISKUS ® Inhlaer and FLIXOTIDE® Inhaler Are Trademarks of GSK Group of Companies.

NCT ID: NCT00169546

Last Updated: 2016-09-15

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

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2005-12-31

Brief Summary

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Comparison of two asthma treatments by lung function measures.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Salmeterol/fluticasone propionate

Intervention Type DRUG

Fluticasone propionate

Intervention Type DRUG

Interventions

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Salmeterol/fluticasone propionate

Intervention Type DRUG

Fluticasone propionate

Intervention Type DRUG

Other Intervention Names

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Salmeterol/fluticasone propionate

Eligibility Criteria

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Inclusion Criteria

* Currently receiving 200-800mcg/day beclomethasone dipropionate.
* sRAW value of 1.3 kPa's.

Exclusion Criteria

* 3 or more courses of oral steroids in last 12 months.
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

Wellington, , New Zealand

Site Status

GSK Investigational Site

Manchester, Lancashire, United Kingdom

Site Status

Countries

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New Zealand United Kingdom

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: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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SAM40100

Identifier Type: -

Identifier Source: org_study_id

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