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Dose Finding Study of Fluticasone Furoate Nasal Spray for Uncomplicated Acute Rhinosinusitis

NCT01018030 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 741

Last updated 2017-05-17

Study results available
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Summary

The purpose of this study is to assess the safety and efficacy of fluticasone furoate nasal spray (FFNS), without the use of an antibiotic, in the treatment of adult and adolescent subjects who are 12 years of age and older with uncomplicated acute rhinosinusitis (ARS).

Conditions

  • Sinusitis, Acute

Interventions

DRUG

FFNS 110 mcg QD

Active Nasal Spray (AM) and Placebo Nasal Spray (PM)

DRUG

FFNS 110 mcg BID

Active Nasal Spray (AM) and Active Nasal Spray (PM)

DRUG

Placebo Nasal Spray

Placebo Nasal Spray (AM) and Placebo Nasal Spray (PM)

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
2010-01-06
Primary Completion
2010-07-01
Completion
2010-07-16

Countries

  • Bulgaria
  • Canada
  • Czechia
  • Estonia
  • Germany
  • Netherlands
  • Norway
  • Poland
  • Russia
  • Spain
  • Sweden
  • Ukraine

Study Locations

More Related Trials

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 NCT01018030 on ClinicalTrials.gov