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Study to Evaluate the Safety and Tolerability of a Nasal Spray in Patients With Chronic Allergic or Nonallergic Rhinitis

NCT00783432 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 862

Last updated 2009-10-06

Study results available
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Summary

The purpose of this study is to determine if Astepro Nasal Spray (0.1% azelastine hydrochloride) is as safe as Astelin Nasal Spray (0.1% azelastine hydrochloride)

Conditions

  • Chronic Allergic Rhinitis
  • Nonallergic Rhinitis

Interventions

DRUG

Astepro Nasal Spray (0.1% azelastine hydrochloride)

548 mcg (2 sprays per nostril) twice a day

DRUG

Astelin Nasal Spray (0.1% azelastine hydrochloride)

548 mcg (2 sprays per nostril) twice a day

Sponsors & Collaborators

  • Meda Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Lewis M. Fredane, MD · Meda Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-07-31
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • United States

Study Locations

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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 NCT00783432 on ClinicalTrials.gov