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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
fluticasone propionate/salmeterol
salmeterol xinafoate
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring genotype, Salmeterol, ADVAIR

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
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Outcomes

Primary Outcome Measures

Evaluate lung function by testing morning peak expiratory flow in patients with a B16 Arg/Arg genotype compared to patients with a B16 Gly/Gly genotype over 16 weeks of treatment with ADVAIR or SEREVENT

Secondary Outcome Measures

Evaluate lung function by testing morning peak expiratory flow in patients with a Arg/Gly genotype compared to patients with a Arg/Arg or a Gly/Gly genotype over 16 weeks of treatment with ADVAIR and/or SEREVENT

Full Information

First Posted
February 3, 2005
Last Updated
February 2, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00102882
Brief Title
Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate
Official Title
Randomized, Double-Blind Comparison of Advair 100/50 BID vs Salmeterol BID vs Albuterol QID in Subjects With ARG/ARG Genotype 12 Years of Age and Older With Presistent Asthma on Short-Acting Beta2-Agonists Alone
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
genotype, Salmeterol, ADVAIR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
547 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fluticasone propionate/salmeterol
Intervention Type
Drug
Intervention Name(s)
salmeterol xinafoate
Other Intervention Name(s)
fluticasone propionate/salmeterol
Primary Outcome Measure Information:
Title
Evaluate lung function by testing morning peak expiratory flow in patients with a B16 Arg/Arg genotype compared to patients with a B16 Gly/Gly genotype over 16 weeks of treatment with ADVAIR or SEREVENT
Secondary Outcome Measure Information:
Title
Evaluate lung function by testing morning peak expiratory flow in patients with a Arg/Gly genotype compared to patients with a Arg/Arg or a Gly/Gly genotype over 16 weeks of treatment with ADVAIR and/or SEREVENT

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
GSK Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
GSK Investigational Site
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
GSK Investigational Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
GSK Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
GSK Investigational Site
City
Inglewood
State/Province
California
ZIP/Postal Code
90301
Country
United States
Facility Name
GSK Investigational Site
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
GSK Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
GSK Investigational Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90808
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
GSK Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
GSK Investigational Site
City
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
GSK Investigational Site
City
Stockton
State/Province
California
ZIP/Postal Code
95207
Country
United States
Facility Name
GSK Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
GSK Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
GSK Investigational Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
GSK Investigational Site
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
GSK Investigational Site
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
GSK Investigational Site
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
GSK Investigational Site
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
GSK Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
GSK Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
GSK Investigational Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
GSK Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
GSK Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
GSK Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30310
Country
United States
Facility Name
GSK Investigational Site
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
GSK Investigational Site
City
Lilburn
State/Province
Georgia
ZIP/Postal Code
30047
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
GSK Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
GSK Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46208
Country
United States
Facility Name
GSK Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
GSK Investigational Site
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
Facility Name
GSK Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70002
Country
United States
Facility Name
GSK Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
GSK Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
GSK Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
GSK Investigational Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
GSK Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
GSK Investigational Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
GSK Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
GSK Investigational Site
City
Warrensburg
State/Province
Missouri
ZIP/Postal Code
64093
Country
United States
Facility Name
GSK Investigational Site
City
Papillion
State/Province
Nebraska
ZIP/Postal Code
68046
Country
United States
Facility Name
GSK Investigational Site
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
GSK Investigational Site
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103-2499
Country
United States
Facility Name
GSK Investigational Site
City
Bayshore
State/Province
New York
ZIP/Postal Code
11706
Country
United States
Facility Name
GSK Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
GSK Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
GSK Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
GSK Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19143
Country
United States
Facility Name
GSK Investigational Site
City
Upland
State/Province
Pennsylvania
ZIP/Postal Code
19013
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
GSK Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
GSK Investigational Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
GSK Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
GSK Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
GSK Investigational Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
GSK Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203-1424
Country
United States
Facility Name
GSK Investigational Site
City
Corsicana
State/Province
Texas
ZIP/Postal Code
75110
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
GSK Investigational Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
GSK Investigational Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79925
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
GSK Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Facility Name
GSK Investigational Site
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
South Burlington
State/Province
Vermont
ZIP/Postal Code
05403
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
GSK Investigational Site
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
GSK Investigational Site
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
GSK Investigational Site
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209-0996
Country
United States
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53219
Country
United States
Facility Name
GSK Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
GSK Investigational Site
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
GSK Investigational Site
City
Nairobi
ZIP/Postal Code
00200
Country
Kenya
Facility Name
GSK Investigational Site
City
San Isidro
State/Province
Lima
ZIP/Postal Code
Lima 27
Country
Peru
Facility Name
GSK Investigational Site
City
Lima
ZIP/Postal Code
Lima 1
Country
Peru
Facility Name
GSK Investigational Site
City
Hato Rey
ZIP/Postal Code
00917
Country
Puerto Rico
Facility Name
GSK Investigational Site
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
19910613
Citation
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.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100062
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100062
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100062
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100062
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100062
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100062
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
SFA100062
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

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