Study Of Asthma In Patients Of African Descent - Tabular View

Tracking Information

First Received Date ^ICMJE

February 1, 2005

Last Updated Date

May 15, 2009

Start Date ^ICMJE

November 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Asthma exacerbation rate per patient per year

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00102765 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Morning peak flow measurement, percent of asthma symptom-free days, percent of albuterol-free days

Original Secondary Outcome Measures ^ICMJE

Morning peak flow measurement
Percent of asthma symptom-free days
Percent of albuterol-free days

Descriptive Information

Brief Title ^ICMJE

Study Of Asthma In Patients Of African Descent

Official Title ^ICMJE

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

Brief Summary

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)

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Asthma

Intervention ^ICMJE

Drug: fluticasone propionate/salmeterol powder
Drug: fluticasone propionate powder

Study Arms / Comparison Groups

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

460

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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).

Gender

Both

Ages

12 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00102765

Responsible Party

Study Director, GSK

Study ID Numbers ^ICMJE

SFA103153

Study Sponsor ^ICMJE

GlaxoSmithKline

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

Information Provided By

GlaxoSmithKline

Verification Date

May 2009

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