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A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis

NCT01279057 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 727

Last updated 2021-02-03

Study results available
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Summary

This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

Conditions

  • Rhinitis, Allergic, Seasonal

Interventions

DRUG

Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals)

Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.

DRUG

Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray

Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.

DRUG

Placebo

Placebo nasal spray administered once daily (4 actuations) for 14 days.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-27
Primary Completion
2011-02-08
Completion
2011-02-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01279057 on ClinicalTrials.gov