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A Study to Evaluate the 24 Hour Spirometric Effect (FEV1) of Fluticasone Furoate/Vilanterol Inhalation Powder (100mcg Fluticasone Furoate (FF)/25mcg Vilanterol (VI)) Compared With Salmeterol/Fluticasone Propionate Inhalation Powder (50mcg Salmeterol/500mcg Fluticasone Propionate (FP))

NCT01342913 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 528

Last updated 2018-08-31

Study results available
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Summary

The purpose of this study is to evaluate the 24-hour spirometry effect (FEV1) of Fluticasone Furoate/Vilanterol 100/25mcg once daily compared with Salmeterol/Fluticasone Propionate 50/500mcg twice daily over a 12-week treatmen period in subjects with COPD.

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Fluticasone Furoate 100mcg/Vilanterol 25mcg

Inhalation Powder

DRUG

Fluticaosne Propionate 500mcg/Salmeterol 50mcg

Inhalation Powder

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-01
Primary Completion
2011-10-01
Completion
2011-10-19

Countries

  • Belgium
  • France
  • Germany
  • Italy
  • Philippines
  • Poland
  • Russia
  • Spain
  • Ukraine

Study Locations

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Entities

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 NCT01342913 on ClinicalTrials.gov