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Study Of Asthma In Patients Of African Descent

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00102765
First Posted: February 2, 2005
Last Update Posted: January 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
February 1, 2005
February 2, 2005
January 18, 2017
November 2004
April 2007   (Final data collection date for primary outcome measure)
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
Not Provided
 
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
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Asthma
  • Drug: fluticasone propionate/salmeterol powder
  • Drug: fluticasone propionate powder
    Other Name: fluticasone propionate/salmeterol powder
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
479
April 2007
April 2007   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
12 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00102765
SFA103153
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
January 2017

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