Study Of Asthma In Patients Of African Descent

Condition(s) targeted: Asthma

Intervention: fluticasone propionate/salmeterol powder (Drug); fluticasone propionate powder (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline

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)

Official title: 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

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Asthma exacerbation rate per patient per year

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

Minimum age: 12 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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).

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Starting date: November 2004
Last updated: January 14, 2008