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Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate

NCT ID: NCT00102882

Last Updated: 2017-02-03

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

547 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2007-01-31

Brief Summary

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This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.

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Detailed Description

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A Randomized, Parallel Group, Double-Blind, Comparative Trial Assessing Lung Function and Other Measures of Asthma Control in Adults and Adolescents, at least 12 Years of Age, with Persistent Asthma, Who Have Either a B16-Arg/Arg, a B16-Gly/Gly or a B-16 Arg/Gly Genotype and are Treated With Fluticasone Propionate/Salmeterol DISKUS™ Combination Product 100/50mcg or Salmeterol DISKUS 50 mcg BID

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

Interventions

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fluticasone propionate/salmeterol

Intervention Type DRUG

salmeterol xinafoate

Intervention Type DRUG

Other Intervention Names

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fluticasone propionate/salmeterol

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of persistent asthma for 3 months.
* Use of short-acting beta-agonist medication like VENTOLIN.

Exclusion Criteria

* Hospitalization for asthma 6 months before study.
* Other serious diseases like congestive heart failure, uncontrolled hypertension, TB.
* Current use of inhaled or oral corticosteroids.
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

Mobile, Alabama, United States

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Little Rock, Arkansas, United States

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Fresno, California, United States

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Fullerton, California, United States

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Huntington Beach, California, United States

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Inglewood, California, United States

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Irvine, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Spring Valley, California, United States

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Stockton, California, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Lakewood, Colorado, United States

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Wheat Ridge, Colorado, United States

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Waterbury, Connecticut, United States

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Coral Gables, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Sarasota, Florida, United States

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South Miami, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Lawrenceville, Georgia, United States

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Lilburn, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Overland Park, Kansas, United States

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Covington, Louisiana, United States

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Metairie, Louisiana, United States

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Shreveport, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Jackson, Mississippi, United States

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Columbia, Missouri, United States

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St Louis, Missouri, United States

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Warrensburg, Missouri, United States

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Papillion, Nebraska, United States

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Hackensack, New Jersey, United States

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Newark, New Jersey, United States

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Bay Shore, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Asheville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Medford, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Upland, Pennsylvania, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Orangeburg, South Carolina, United States

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Spartanburg, South Carolina, United States

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Chattanooga, Tennessee, United States

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Knoxville, Tennessee, United States

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Nashville, Tennessee, United States

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Corsicana, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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El Paso, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Kerrville, Texas, United States

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San Antonio, Texas, United States

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South Burlington, Vermont, United States

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Richmond, Virginia, United States

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Bellingham, Washington, United States

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Kirkland, Washington, United States

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Madison, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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GSK Investigational Site

Milwaukee, Wisconsin, United States

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GSK Investigational Site

West Allis, Wisconsin, United States

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GSK Investigational Site

Nairobi, , Kenya

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GSK Investigational Site

Lima, Lima Province, Peru

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GSK Investigational Site

San Isidro, Lima region, Peru

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GSK Investigational Site

Hato Rey, Puerto Rico, Puerto Rico

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GSK Investigational Site

Ponce, Puerto Rico, Puerto Rico

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Countries

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United States Kenya Peru Puerto Rico

References

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Bleecker ER, Nelson HS, Kraft M, Corren J, Meyers DA, Yancey SW, Anderson WH, Emmett AH, Ortega HG. Beta2-receptor polymorphisms in patients receiving salmeterol with or without fluticasone propionate. Am J Respir Crit Care Med. 2010 Apr 1;181(7):676-87. doi: 10.1164/200809-1511OC. Epub 2009 Nov 12.

Reference Type DERIVED
PMID: 19910613 (View on PubMed)

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: Annotated Case Report Form

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: Study Protocol

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: Dataset Specification

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

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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SFA100062

Identifier Type: -

Identifier Source: org_study_id

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