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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: salmeterol xinafoate; Drug: fluticasone propionate/salmeterol

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

• Study Type: Interventional
• Enrollment (Actual): 547
• Phase: Phase 4

Contacts and Locations

Study Locations

• Kenya
  • Nairobi, Kenya, 00200
    • GSK Investigational Site
• Peru
  • Lima, Peru, Lima 1
    • GSK Investigational Site
  • Lima
    • San Isidro, Lima, Peru, Lima 27
      • GSK Investigational Site
• Puerto Rico
  • Hato Rey, Puerto Rico, 00917
    • GSK Investigational Site
  • Ponce, Puerto Rico, 00716
    • GSK Investigational Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • GSK Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • GSK Investigational Site
  • California
    • Fresno, California, United States, 93720
      • GSK Investigational Site
    • Fullerton, California, United States, 92835
      • GSK Investigational Site
    • Huntington Beach, California, United States, 92647
      • GSK Investigational Site
    • Inglewood, California, United States, 90301
      • GSK Investigational Site
    • Irvine, California, United States, 92618
      • GSK Investigational Site
    • Long Beach, California, United States, 90808
      • GSK Investigational Site
    • Long Beach, California, United States, 90806
      • GSK Investigational Site
    • Los Angeles, California, United States, 90025
      • GSK Investigational Site
    • Los Angeles, California, United States, 90048
      • GSK Investigational Site
    • Orange, California, United States, 92868
      • GSK Investigational Site
    • Spring Valley, California, United States, 91978
      • GSK Investigational Site
    • Stockton, California, United States, 95207
      • GSK Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • GSK Investigational Site
    • Denver, Colorado, United States, 80206
      • GSK Investigational Site
    • Denver, Colorado, United States, 80209
      • GSK Investigational Site
    • Lakewood, Colorado, United States, 80401
      • GSK Investigational Site
    • Wheat Ridge, Colorado, United States, 80033
      • GSK Investigational Site
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • GSK Investigational Site
  • Florida
    • Coral Gables, Florida, United States, 33134
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32207
      • GSK Investigational Site
    • Miami, Florida, United States, 33136
      • GSK Investigational Site
    • Miami, Florida, United States, 33176
      • GSK Investigational Site
    • Orlando, Florida, United States, 32806
      • GSK Investigational Site
    • Sarasota, Florida, United States, 34233
      • GSK Investigational Site
    • South Miami, Florida, United States, 33143
      • GSK Investigational Site
    • Tallahassee, Florida, United States, 32308
      • GSK Investigational Site
    • Tampa, Florida, United States, 33613
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30310
      • GSK Investigational Site
    • Lawrenceville, Georgia, United States, 30045
      • GSK Investigational Site
    • Lilburn, Georgia, United States, 30047
      • GSK Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • GSK Investigational Site
    • Chicago, Illinois, United States, 60612
      • GSK Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46208
      • GSK Investigational Site
  • Kansas
    • Overland Park, Kansas, United States, 66210
      • GSK Investigational Site
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • GSK Investigational Site
    • Metairie, Louisiana, United States, 70002
      • GSK Investigational Site
    • Shreveport, Louisiana, United States, 71105
      • GSK Investigational Site
    • Shreveport, Louisiana, United States, 71104
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • GSK Investigational Site
    • Baltimore, Maryland, United States, 21237
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • GSK Investigational Site
    • North Dartmouth, Massachusetts, United States, 02747
      • GSK Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • GSK Investigational Site
  • Missouri
    • Columbia, Missouri, United States, 65203
      • GSK Investigational Site
    • St. Louis, Missouri, United States, 63141
      • GSK Investigational Site
    • Warrensburg, Missouri, United States, 64093
      • GSK Investigational Site
  • Nebraska
    • Papillion, Nebraska, United States, 68046
      • GSK Investigational Site
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • GSK Investigational Site
    • Newark, New Jersey, United States, 07103-2499
      • GSK Investigational Site
  • New York
    • Bayshore, New York, United States, 11706
      • GSK Investigational Site
    • New York, New York, United States, 10021
      • GSK Investigational Site
    • Rochester, New York, United States, 14618
      • GSK Investigational Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27157
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • GSK Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • GSK Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19143
      • GSK Investigational Site
    • Upland, Pennsylvania, United States, 19013
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • GSK Investigational Site
    • Charleston, South Carolina, United States, 29414
      • GSK Investigational Site
    • Orangeburg, South Carolina, United States, 29118
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • GSK Investigational Site
    • Knoxville, Tennessee, United States, 37920
      • GSK Investigational Site
    • Nashville, Tennessee, United States, 37203-1424
      • GSK Investigational Site
  • Texas
    • Corsicana, Texas, United States, 75110
      • GSK Investigational Site
    • Dallas, Texas, United States, 75246
      • GSK Investigational Site
    • Dallas, Texas, United States, 75230
      • GSK Investigational Site
    • El Paso, Texas, United States, 79925
      • GSK Investigational Site
    • El Paso, Texas, United States, 79902
      • GSK Investigational Site
    • Fort Worth, Texas, United States, 76104
      • GSK Investigational Site
    • Houston, Texas, United States, 77054
      • GSK Investigational Site
    • Kerrville, Texas, United States, 78028
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
  • Vermont
    • South Burlington, Vermont, United States, 05403
      • GSK Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23229
      • GSK Investigational Site
  • Washington
    • Bellingham, Washington, United States, 98225
      • GSK Investigational Site
    • Kirkland, Washington, United States, 98034
      • GSK Investigational Site
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • GSK Investigational Site
    • Milwaukee, Wisconsin, United States, 53226
      • GSK Investigational Site
    • Milwaukee, Wisconsin, United States, 53209-0996
      • GSK Investigational Site
    • Milwaukee, Wisconsin, United States, 53219
      • GSK Investigational Site
    • West Allis, Wisconsin, United States, 53227
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: October 1, 2004
• Primary Completion (Actual): January 1, 2007
• Study Completion (Actual): January 1, 2007

Study Registration Dates

• First Submitted: February 3, 2005
• First Submitted That Met QC Criteria: February 3, 2005
• First Posted (Estimate): February 4, 2005

Study Record Updates

• Last Update Posted (Estimate): February 3, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: genotype; Salmeterol; ADVAIR
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Sympathomimetics; Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
• Other Study ID Numbers: SFA100062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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.

Study Data/Documents

1. Informed Consent Form
   Information identifier: SFA100062
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Annotated Case Report Form
   Information identifier: SFA100062
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: SFA100062
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Study Protocol
   Information identifier: SFA100062
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: SFA100062
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Dataset Specification
   Information identifier: SFA100062
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Clinical Study Report
   Information identifier: SFA100062
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register