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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00102882
• Other study ID #: SFA100062
• Status: Completed
• Phase: Phase 4
• First received: February 3, 2005
• Last updated: February 2, 2017
• Start date: October 2004
• Est. completion date: January 2007

Study information

• Verified date: February 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 547
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• fluticasone propionate/salmeterol

• salmeterol xinafoate

Locations

Country	Name	City	State
Kenya	GSK Investigational Site	Nairobi
Peru	GSK Investigational Site	Lima
Peru	GSK Investigational Site	San Isidro	Lima
Puerto Rico	GSK Investigational Site	Hato Rey
Puerto Rico	GSK Investigational Site	Ponce
United States	GSK Investigational Site	Asheville	North Carolina
United States	GSK Investigational Site	Atlanta	Georgia
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Baltimore	Maryland
United States	GSK Investigational Site	Bayshore	New York
United States	GSK Investigational Site	Bellingham	Washington
United States	GSK Investigational Site	Boston	Massachusetts
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Charleston	South Carolina
United States	GSK Investigational Site	Chattanooga	Tennessee
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Chicago	Illinois
United States	GSK Investigational Site	Colorado Springs	Colorado
United States	GSK Investigational Site	Columbia	Missouri
United States	GSK Investigational Site	Coral Gables	Florida
United States	GSK Investigational Site	Corsicana	Texas
United States	GSK Investigational Site	Covington	Louisiana
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Dallas	Texas
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	Denver	Colorado
United States	GSK Investigational Site	El Paso	Texas
United States	GSK Investigational Site	El Paso	Texas
United States	GSK Investigational Site	Fort Worth	Texas
United States	GSK Investigational Site	Fresno	California
United States	GSK Investigational Site	Fullerton	California
United States	GSK Investigational Site	Hackensack	New Jersey
United States	GSK Investigational Site	Houston	Texas
United States	GSK Investigational Site	Huntington Beach	California
United States	GSK Investigational Site	Indianapolis	Indiana
United States	GSK Investigational Site	Inglewood	California
United States	GSK Investigational Site	Irvine	California
United States	GSK Investigational Site	Jackson	Mississippi
United States	GSK Investigational Site	Jacksonville	Florida
United States	GSK Investigational Site	Kerrville	Texas
United States	GSK Investigational Site	Kirkland	Washington
United States	GSK Investigational Site	Knoxville	Tennessee
United States	GSK Investigational Site	Lakewood	Colorado
United States	GSK Investigational Site	Lawrenceville	Georgia
United States	GSK Investigational Site	Lilburn	Georgia
United States	GSK Investigational Site	Little Rock	Arkansas
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Long Beach	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Los Angeles	California
United States	GSK Investigational Site	Madison	Wisconsin
United States	GSK Investigational Site	Medford	Oregon
United States	GSK Investigational Site	Metairie	Louisiana
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Miami	Florida
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Milwaukee	Wisconsin
United States	GSK Investigational Site	Mobile	Alabama
United States	GSK Investigational Site	Nashville	Tennessee
United States	GSK Investigational Site	New York	New York
United States	GSK Investigational Site	Newark	New Jersey
United States	GSK Investigational Site	North Dartmouth	Massachusetts
United States	GSK Investigational Site	Oklahoma City	Oklahoma
United States	GSK Investigational Site	Orange	California
United States	GSK Investigational Site	Orangeburg	South Carolina
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Overland Park	Kansas
United States	GSK Investigational Site	Papillion	Nebraska
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Philadelphia	Pennsylvania
United States	GSK Investigational Site	Richmond	Virginia
United States	GSK Investigational Site	Rochester	New York
United States	GSK Investigational Site	San Antonio	Texas
United States	GSK Investigational Site	Sarasota	Florida
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	Shreveport	Louisiana
United States	GSK Investigational Site	South Burlington	Vermont
United States	GSK Investigational Site	South Miami	Florida
United States	GSK Investigational Site	Spartanburg	South Carolina
United States	GSK Investigational Site	Spring Valley	California
United States	GSK Investigational Site	St. Louis	Missouri
United States	GSK Investigational Site	Stockton	California
United States	GSK Investigational Site	Tallahassee	Florida
United States	GSK Investigational Site	Tampa	Florida
United States	GSK Investigational Site	Upland	Pennsylvania
United States	GSK Investigational Site	Warrensburg	Missouri
United States	GSK Investigational Site	Waterbury	Connecticut
United States	GSK Investigational Site	West Allis	Wisconsin
United States	GSK Investigational Site	Wheat Ridge	Colorado
United States	GSK Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Kenya,  Peru,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

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