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A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg BID To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg BID In Symptomatic Subjects With Asthma

NCT00452699 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 621

Last updated 2016-12-08

Study results available
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Summary

This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

Conditions

Interventions

DRUG

Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

DRUG

Fluticasone propionate 250 mcg BID

Fluticasone propionate 250 mcg BID

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-05-31
Completion
2009-05-31

Countries

  • United States
  • Argentina
  • Brazil
  • Canada
  • Philippines

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 NCT00452699 on ClinicalTrials.gov