A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

NCT00740792 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 776

Last updated 2012-09-07

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine if two allergy medications (formulated azelastine and fluticasone product) are more effective than placebo or either medication alone (azelastine or fluticasone)

Conditions

  • Seasonal Allergic Rhinitis

Interventions

DRUG

azelastine HCl/fluticasone propionate

azelastine HCl 548 mcg/ fluticasone propionate 200 mcg one spray per nostril BID

DRUG

azelastine Hcl

azelastine Hcl 548 mcg one spray per nostril BID

DRUG

fluticasone propionate

fluticasone propionate 200 mcg one spray per nostril BID

DRUG

placebo

placebo one spray per nostril BID

Sponsors & Collaborators

  • Meda Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lewis M Fredane, MD · Meda Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00740792 on ClinicalTrials.gov