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Clinical trial

SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma. (AUSTRI)

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Last updated:1st Nov 2011

The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma
Enrollment: 11751
Study Start Date: November 2011
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
ADVAIR 100/50mcg
- Experimental: ADVAIR 250/50mcg
- Experimental: ADVAIR 500/50mcg
- Active Comparator: FLOVENT 100mcg
- Active Comparator: FLOVENT 250mcg
- Active Comparator: FLOVENT 500mcg


Related journal: Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone.

Category Value
Study start date 2011-11-01

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