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GSK BHR Study (Sont - Second Study)

NCT ID: NCT01324362

Last Updated: 2016-09-01

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

446 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2004-10-31

Brief Summary

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The purpose of this study was to determine whether asthma control and reduced bronchial responsiveness could be achieved and maintained at a lower dose of inhaled corticosteroids with ADVAIR DISKUS BID or FP BID in adult and adolescent patients with persistent asthma

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A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg Twice Daily To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg Twice Daily In Symptomatic Patients With Asthma

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A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg BID To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg BID In Symptomatic Subjects With Asthma

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Randomized, Placebo-controlled Study Comparing Efficacy of Fluticasone/Salmeterol Combination to Advair in Asthmatics

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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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Fluticasone propionate

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Twice daily dosing

FP 100mcg

Intervention Type DRUG

Twice daily dosing

FP 250mcg

Intervention Type DRUG

Twice daily dosing

FP 500mcg

Intervention Type DRUG

Twice daily dosing

Fluticasone propionate/salmeterol combination

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Twice daily dosing

FSC 100/50mcg

Intervention Type DRUG

Twice daily dosing

FSC 250/50mcg

Intervention Type DRUG

Twice daily dosing

FSC500/50mcg

Intervention Type DRUG

Twice daily dosing

Interventions

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Placebo

Twice daily dosing

Intervention Type DRUG

Placebo

Twice daily dosing

Intervention Type DRUG

FP 100mcg

Twice daily dosing

Intervention Type DRUG

FP 250mcg

Twice daily dosing

Intervention Type DRUG

FP 500mcg

Twice daily dosing

Intervention Type DRUG

FSC 100/50mcg

Twice daily dosing

Intervention Type DRUG

FSC 250/50mcg

Twice daily dosing

Intervention Type DRUG

FSC500/50mcg

Twice daily dosing

Intervention Type DRUG

Other Intervention Names

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FP 100mcg FP 250mcg FP 500mcg

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of asthma
* Controller asthma medication or medium dose ICS
* Current or historical reversibility

Exclusion Criteria

* Life-threatening asthma
* Asthma instability
* Concurrent respiratory disease
* Drug allergies
* Respiratory tract infection
* Systemic corticosteroid use
* Immunosuppressive medication use
* Postive pregnancy test
* Tobacco use
* Investigation medication use
* Site affiliation
Minimum Eligible Age

12 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

Birmingham, Alabama, United States

Site Status

GSK Investigational Site

Jasper, Alabama, United States

Site Status

GSK Investigational Site

Glendale, Arizona, United States

Site Status

GSK Investigational Site

Tucson, Arizona, United States

Site Status

GSK Investigational Site

Huntington Beach, California, United States

Site Status

GSK Investigational Site

Long Beach, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Los Angeles, California, United States

Site Status

GSK Investigational Site

Denver, Colorado, United States

Site Status

GSK Investigational Site

Englewood, Colorado, United States

Site Status

GSK Investigational Site

Fort Collins, Colorado, United States

Site Status

GSK Investigational Site

Pueblo, Colorado, United States

Site Status

GSK Investigational Site

Wheat Ridge, Colorado, United States

Site Status

GSK Investigational Site

Aventura, Florida, United States

Site Status

GSK Investigational Site

Jacksonville, Florida, United States

Site Status

GSK Investigational Site

Longwood, Florida, United States

Site Status

GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

Tampa, Florida, United States

Site Status

GSK Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

GSK Investigational Site

Oak Brook, Illinois, United States

Site Status

GSK Investigational Site

South Bend, Indiana, United States

Site Status

GSK Investigational Site

Des Moines, Iowa, United States

Site Status

GSK Investigational Site

Baltimore, Maryland, United States

Site Status

GSK Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

GSK Investigational Site

Livonia, Michigan, United States

Site Status

GSK Investigational Site

Chesterfield, Missouri, United States

Site Status

GSK Investigational Site

Omaha, Nebraska, United States

Site Status

GSK Investigational Site

Omaha, Nebraska, United States

Site Status

GSK Investigational Site

Mineola, New York, United States

Site Status

GSK Investigational Site

Charlotte, North Carolina, United States

Site Status

GSK Investigational Site

Wilmington, North Carolina, United States

Site Status

GSK Investigational Site

Winston-Salem, North Carolina, United States

Site Status

GSK Investigational Site

Cincinnati, Ohio, United States

Site Status

GSK Investigational Site

Cleveland, Ohio, United States

Site Status

GSK Investigational Site

Toledo, Ohio, United States

Site Status

GSK Investigational Site

Eugene, Oregon, United States

Site Status

GSK Investigational Site

Lake Oswego, Oregon, United States

Site Status

GSK Investigational Site

Upland, Pennsylvania, United States

Site Status

GSK Investigational Site

Spartanburg, South Carolina, United States

Site Status

GSK Investigational Site

Knoxville, Tennessee, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Dallas, Texas, United States

Site Status

GSK Investigational Site

Friendswood, Texas, United States

Site Status

GSK Investigational Site

Houston, Texas, United States

Site Status

GSK Investigational Site

Danville, Virginia, United States

Site Status

GSK Investigational Site

Richmond, Virginia, United States

Site Status

GSK Investigational Site

Bellingham, Washington, United States

Site Status

GSK Investigational Site

Seattle, Washington, United States

Site Status

GSK Investigational Site

Madison, Wisconsin, United States

Site Status

GSK Investigational Site

Milwaukee, Wisconsin, United States

Site Status

GSK Investigational Site

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

GSK Investigational Site

Florianópolis, Santa Catarina, Brazil

Site Status

GSK Investigational Site

São Paulo, São Paulo, Brazil

Site Status

GSK Investigational Site

Sofia, , Bulgaria

Site Status

GSK Investigational Site

Varna, , Bulgaria

Site Status

GSK Investigational Site

San Juan, Puerto Rico, Puerto Rico

Site Status

Countries

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United States Brazil Bulgaria Puerto Rico

References

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Stauffer JL, Yancey SW, Baitinger LA, Prillaman BA, Dorinsky PM. Measuring airway hyperresponsiveness: Does it add to routine measures of clinical efficacy in guiding asthma therapy? Proc Am Thorac Soc 2006;3:A213

Reference Type BACKGROUND

Study Documents

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Document Type: Informed Consent Form

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: Statistical Analysis Plan

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

View Document

Document Type: Annotated Case Report 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: Individual Participant Data Set

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

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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SAM40065

Identifier Type: -

Identifier Source: org_study_id

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