Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00102882
First received: February 3, 2005
Last updated: October 4, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: fluticasone propionate/salmeterol Drug: salmeterol xinafoate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | See Detailed Description |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
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
| Estimated Enrollment: | 540 |
| Study Start Date: | October 2004 |
Intervention Details:
Detailed Description:
-
Drug: fluticasone propionate/salmeterol
Drug: salmeterol xinafoate
- fluticasone propionate/salmeterol
- salmeterol xinafoate
Other Names:
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
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102882
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| United States, Alabama | |
| GSK Investigational Site | |
| Mobile, Alabama, United States, 36608 | |
| United States, Arkansas | |
| GSK Investigational Site | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| GSK Investigational Site | |
| 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 | |
| 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 | |
| United States, Colorado | |
| GSK Investigational Site | |
| Colorado Springs, Colorado, United States, 80907 | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80209 | |
| GSK Investigational Site | |
| Denver, Colorado, United States, 80206 | |
| GSK Investigational Site | |
| Lakewood, Colorado, United States, 80401 | |
| GSK Investigational Site | |
| Wheat Ridge, Colorado, United States, 80033 | |
| United States, Connecticut | |
| GSK Investigational Site | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| GSK Investigational Site | |
| Coral Gables, Florida, United States, 33134 | |
| GSK Investigational Site | |
| Jacksonville, Florida, United States, 32207 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33176 | |
| GSK Investigational Site | |
| Miami, Florida, United States, 33136 | |
| 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 | |
| United States, Georgia | |
| GSK Investigational Site | |
| Atlanta, Georgia, United States, 30310 | |
| GSK Investigational Site | |
| Lawrenceville, Georgia, United States, 30045 | |
| GSK Investigational Site | |
| Lilburn, Georgia, United States, 30047 | |
| United States, Illinois | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60612 | |
| GSK Investigational Site | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| GSK Investigational Site | |
| Indianapolis, Indiana, United States, 46208 | |
| United States, Louisiana | |
| GSK Investigational Site | |
| Covington, Louisiana, United States, 70433 | |
| GSK Investigational Site | |
| Metairie, Louisiana, United States, 70002 | |
| GSK Investigational Site | |
| Shreveport, Louisiana, United States, 71105 | |
| United States, Maryland | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21237 | |
| GSK Investigational Site | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| GSK Investigational Site | |
| North Dartmouth, Massachusetts, United States, 02747 | |
| United States, Mississippi | |
| GSK Investigational Site | |
| Jackson, Mississippi, United States, 39202 | |
| United States, Missouri | |
| GSK Investigational Site | |
| Columbia, Missouri, United States, 65203 | |
| GSK Investigational Site | |
| St. Louis, Missouri, United States, 63141 | |
| GSK Investigational Site | |
| Warrensburg, Missouri, United States, 64093 | |
| United States, New Jersey | |
| GSK Investigational Site | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| GSK Investigational Site | |
| 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 | |
| United States, North Carolina | |
| GSK Investigational Site | |
| Asheville, North Carolina, United States, 28801 | |
| GSK Investigational Site | |
| Durham, North Carolina, United States, 27705 | |
| GSK Investigational Site | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Oklahoma | |
| GSK Investigational Site | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| United States, Oregon | |
| GSK Investigational Site | |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| GSK Investigational Site | |
| Philadelphia, Pennsylvania, United States, 19143 | |
| GSK Investigational Site | |
| Upland, Pennsylvania, United States, 19013 | |
| United States, South Carolina | |
| GSK Investigational Site | |
| Charleston, South Carolina, United States, 29414 | |
| GSK Investigational Site | |
| Charleston, South Carolina, United States, 29407 | |
| GSK Investigational Site | |
| Orangeburg, South Carolina, United States, 29118 | |
| GSK Investigational Site | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| GSK Investigational Site | |
| Chattanooga, Tennessee, United States, 37421 | |
| GSK Investigational Site | |
| Knoxville, Tennessee, United States, 37920 | |
| GSK Investigational Site | |
| Nashville, Tennessee, United States, 37203-1424 | |
| United States, Texas | |
| GSK Investigational Site | |
| Corsicana, Texas, United States, 75110 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75230 | |
| GSK Investigational Site | |
| Dallas, Texas, United States, 75246 | |
| GSK Investigational Site | |
| El Paso, Texas, United States, 79902 | |
| GSK Investigational Site | |
| El Paso, Texas, United States, 79925 | |
| 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 | |
| United States, Vermont | |
| GSK Investigational Site | |
| South Burlington, Vermont, United States, 05403 | |
| United States, Virginia | |
| GSK Investigational Site | |
| Richmond, Virginia, United States, 23229 | |
| United States, Washington | |
| GSK Investigational Site | |
| Bellingham, Washington, United States, 98225 | |
| United States, Wisconsin | |
| GSK Investigational Site | |
| 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 | |
| Kenya | |
| GSK Investigational Site | |
| Nairobi, Kenya, 00200 | |
| Peru | |
| GSK Investigational Site | |
| San Isidro, Lima, Peru, Lima 27 | |
| Puerto Rico | |
| GSK Investigational Site | |
| Hato Rey, Puerto Rico, 00917 | |
| GSK Investigational Site | |
| Ponce, Puerto Rico, 00716 | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided by GlaxoSmithKline
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00102882 History of Changes |
| Other Study ID Numbers: | SFA100062 |
| Study First Received: | February 3, 2005 |
| Last Updated: | October 4, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
Salmeterol genotype ADVAIR |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Salmeterol Albuterol Fluticasone Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Tocolytic Agents Reproductive Control Agents Dermatologic Agents Anti-Allergic Agents |
ClinicalTrials.gov processed this record on May 19, 2013