Study In Asthma Control

Condition(s) targeted: Asthma

Intervention: salmeterol xinafoate/fluticasone propionate (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: GlaxoSmithKline

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

This study will compare patients treated with a marketed medication and those who continue with their usual care to assess the proportion of patients achieving well controlled asthma after 24 weeks.

Official title: An Open-Label, Multi-Centre, Randomized, Parallel Group Clinical Effectiveness Study to Determine the Level of Asthma Control in Adolescent and Adult Patients With ADVAIR Versus Usual Care for 24 Weeks.

Study design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study

Primary outcome: Percentage of patients achieving well-controlled asthma at the end of the treatment period.

Secondary outcome: Percentage of patients achieving total asthma control as defined by the Canadian Asthma consensus guidelines at the end of the treatment period.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- documented clinical history of asthma and receiving regular maintenance therapy.

Exclusion Criteria:

- Using oral/parenteral or depot corticosteroids within 12 weeks of visit 1.

- History of heavy smoking or substance abuse.

- Females who are pregnant or lactating.

- Required emergency room treatment for their asthma 12 weeks prior to Visit 1.

- Serious, uncontrolled, systemic disease that may make study participation unsafe or

inappropriate in the opinion of the physician.

- Other medical criteria will be evaluated at the screening visit.

GSK Clinical Trials Call Center, Edmonton, Alberta T5A 0A3, Canada

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Starting date: November 2004
Last updated: May 26, 2006