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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 4

Conditions

Asthma

Treatments

Drug: fluticasone propionate/salmeterol

Drug: salmeterol xinafoate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00102882

SFA100062

Details and patient eligibility

About

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.

Full 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

Enrollment

547 patients

Sex

All

Ages

12+ years old

Volunteers

No 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.