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A 12-Week Study To Assess The Safety Of Fluticasone Propionate/Salmeterol 100/50 Hydrofluoroalkane (HFA) Versus Fluticasone Propionate 100 HFA In Children With Asthma

NCT ID: NCT00441441

Last Updated: 2016-12-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-01-31

Brief Summary

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This study is to assess the safety of an investigational drug in children 4 to 11 years of age who have asthma. The subjects will attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests performed.

Detailed Description

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Conditions

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Asthma

Keywords

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asthma fluticasone propionate children fluticasone propionate/salmeterol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fluticasone propionate/salmeterol 100/50 HFA

Fluticasone propionate/salmeterol 100/50 HFA (2 inhalations of 50/25mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate 100mcg HFA inhaler (2 inhalations) twice daily

Group Type EXPERIMENTAL

fluticasone propionate/salmeterol

Intervention Type DRUG

fluticasone propionate/salmeterol 100/50mcg HFA

Fluticasone propionate 100mcg HFA

Fluticasone propionate 100mcg HFA (2 inhalations of 50mcg), twice daily (strengths are ex-valve) and a placebo HFA inhaler matching the fluticasone propionate/salmeterol 100/50 HFA inhaler (2 inhalations ) twice daily

Group Type EXPERIMENTAL

fluticasone propionate

Intervention Type DRUG

fluticasone propionate 100mcg HFA

Interventions

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fluticasone propionate

fluticasone propionate 100mcg HFA

Intervention Type DRUG

fluticasone propionate/salmeterol

fluticasone propionate/salmeterol 100/50mcg HFA

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must have asthma.
* Must be currently taking an inhaled corticosteroid.
* Must be able to attend 7 clinic visits, of which up to 3 will be in the morning, and have lung function tests that are at least 60% of normal (AM FEV1 or PEF).
* Have a historical or current FEV1 or PEF reversibility of \>=12%.

Exclusion Criteria

* Has ever had life-threatening asthma (for example respiratory arrest, mechanical ventilation).
* Has a current ear or respiratory tract infection.
* Has ever had any other major illnesses (such as cystic fibrosis, heart problems, tuberculosis).
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

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Long Beach, California, United States

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Long Beach, California, United States

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Riverside, California, United States

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Denver, Colorado, United States

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Lakewood, Colorado, United States

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Jacksonville, Florida, United States

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Gainesville, Georgia, United States

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Ypsilanti, Michigan, United States

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Cortland, New York, United States

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Raleigh, North Carolina, United States

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Canton, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Lake Oswego, Oregon, United States

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Medford, Oregon, United States

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Portland, Oregon, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Germantown, Tennessee, United States

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South Burlington, Vermont, United States

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Clayton, Victoria, Australia

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Parkville, Victoria, Australia

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Subiaco, Western Australia, Australia

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St. John's, Newfoundland and Labrador, Canada

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Brampton, Ontario, Canada

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Mississauga, Ontario, Canada

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Sarnia, Ontario, Canada

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Viña del Mar, Región de Valparaíso, Chile

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Santiago, Región Metro de Santiago, Chile

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Santiago, , Chile

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San José, , Costa Rica

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Bochum, North Rhine-Westphalia, Germany

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Gütersloh, North Rhine-Westphalia, Germany

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Kleve-Materborn, North Rhine-Westphalia, Germany

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Wesel, North Rhine-Westphalia, Germany

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Mainz, Rhineland-Palatinate, Germany

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Geesthacht, Schleswig-Holstein, Germany

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Ogre, , Latvia

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Riga, , Latvia

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Kaunas, , Lithuania

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Utena, , Lithuania

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Vilnius, , Lithuania

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Chihuahua City, Chihuahua, Mexico

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Monterrey N.L, Nuevo León, Mexico

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Mexico City, , Mexico

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México, , Mexico

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Lima, Lima Province, Peru

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Lodz, , Poland

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Rabka-Zdrój, , Poland

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Moscow, , Russia

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Novosibirsk, , Russia

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St'Petersburg, , Russia

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Tomsk, , Russia

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Murcia, , Spain

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GSK Investigational Site

San Javier (Murcia), , Spain

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Countries

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United States Australia Canada Chile Costa Rica Germany Latvia Lithuania Mexico Peru Poland Russia Spain

References

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Li JS, Qaqundah PY, Weinstein SF, LaForce CF, Ellsworth AV, Ortega HG, Ferro TJ. Fluticasone propionate/salmeterol combination in children with asthma: key cardiac and overall safety results. Clin Res Reg Affairs 2010;27(3):87-95.

Reference Type BACKGROUND

Study Documents

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Document Type: Annotated Case Report Form

View Document

Document Type: Informed Consent Form

View Document

Document Type: Individual Participant Data Set

View Document

Document Type: Clinical Study Report

View Document

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Dataset Specification

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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SFA106484

Identifier Type: -

Identifier Source: org_study_id