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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.

NCT01475721 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11751

Last updated 2018-08-06

Study results available
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Summary

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.

Conditions

Interventions

DRUG

ADVAIR 100/50mcg

fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months

DRUG

ADVAIR 250/50mcg

fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months

DRUG

ADVAIR 500/50mcg

fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months

DRUG

FLOVENT 100mcg

fluticasone propionate (100) twice daily (AM and PM) for 6 months

DRUG

FLOVENT 250mcg

fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months

DRUG

FLOVENT 500mcg

fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-18
Primary Completion
2015-06-23
Completion
2015-06-23

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Croatia
  • Czechia
  • Denmark
  • Germany
  • Hungary
  • Indonesia
  • Italy
  • Latvia
  • Lithuania
  • Malaysia
  • Mexico
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • Serbia
  • Slovakia
  • South Africa
  • South Korea
  • Spain
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01475721 on ClinicalTrials.gov