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Study Of Asthma In Patients Of African Descent

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00102765
First received: February 1, 2005
Last updated: May 31, 2012
Last verified: March 2011
History of Changes

February 1, 2005
May 31, 2012
November 2004
Not Provided
Asthma exacerbation rate per patient per year
Not Provided
Complete list of historical versions of study NCT00102765 on ClinicalTrials.gov Archive Site
Morning peak flow measurement, percent of asthma symptom-free days, percent of albuterol-free days
Not Provided
Not Provided
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Study Of Asthma In Patients Of African Descent
A Multicenter, Randomized, Double-Blind, Parallel Group, 52-Week Comparison of Asthma Control and Measures of Airway Inflammation in Subjects of African Descent Receiving Fluticasone Propionate/Salmeterol 100/50mcg DISKUS® BID or Fluticasone Propionate 100mcg DISKUS® BID Alone

This study will last up to 62 weeks. You will visit the clinic up to 17 times. Certain clinic visits will include physical examination, medical history review and lung function tests. The purpose of this study is to see if one asthma drug (fluticasone propionate/salmeterol) is better in reducing the number of asthma exacerbations compared with another drug (fluticasone propionate alone)
Not Provided
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 powder
  • Drug: fluticasone propionate powder
    Other Names:
    • fluticasone propionate/salmeterol powder
    • fluticasone propionate powder
Not Provided
Bailey W, Castro M, Matz J, White M, Dransfield M, Yancey S, Ortega H. Asthma exacerbations in African Americans treated for 1 year with combination fluticasone propionate and salmeterol or fluticasone propionate alone. Curr Med Res Opin. 2008 Jun;24(6):1669-82. Epub 2008 May 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
460
Not Provided
Not Provided

Inclusion criteria:

  • History of asthma for at least 6 months.
  • Taking a low-dose of an inhaled corticosteroid for at least one month prior to the study (such as fluticasone propionate or budesonide).

Exclusion criteria:

  • History of life-threatening asthma.
  • Hospitalized for asthma within 3 months prior to the study.
  • Current respiratory tract infection.
  • Will not be able to attend clinic visits for the entire length of the study.
  • Certain medical conditions that will make being in the study unsafe (such as congestive heart failure, uncontrolled hypertension, tuberculosis or certain drug allergies).
Both
12 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00102765
SFA103153
No
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2011

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