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

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00102882

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 IV

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone Fluticasone propionate Salmeterol Salmeterol xinafoate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	See Detailed Description

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

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

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

Show 85 Study Locations

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SFA100062
Study First Received:	February 3, 2005
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00102882
Health Authority:	United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:

genotype
ADVAIR
Salmeterol

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Salmeterol
Respiratory Tract Diseases
Lung Diseases

Albuterol
Hypersensitivity, Immediate
Fluticasone
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Immune System Diseases
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Asthmatic Agents

Anti-Allergic Agents
Reproductive Control Agents
Adrenergic Agonists
Pharmacologic Actions
Tocolytic Agents
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 15, 2009