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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00102882
First received: February 3, 2005
Last updated: October 4, 2012
Last verified: September 2012

February 3, 2005
October 4, 2012
October 2004
Not Provided
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
Not Provided
Complete list of historical versions of study NCT00102882 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate
See Detailed Description

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.

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

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Asthma
  • Drug: fluticasone propionate/salmeterol
  • Drug: salmeterol xinafoate
    Other Names:
    • fluticasone propionate/salmeterol
    • salmeterol xinafoate
Not Provided
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. Epub 2009 Nov 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
540
Not Provided
Not Provided

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.
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Kenya,   Peru,   Puerto Rico
 
NCT00102882
SFA100062
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP