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Investigation of the Efficacy and Safety of Concomitant Administration of Ciclesonide Nasal Spray and Azelastine Nasal Spray in Patients (18 Years or Older) With Perennial Allergic Rhinitis (PAR) Not Adequately Controlled on an Intranasal Corticosteroid or Antihistamine Monotherapy (BY9010/M1-490)

NCT00806754 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 340

Last updated 2016-11-23

No results posted yet for this study

Summary

* The primary objective of this study is to evaluate the efficacy of the concomitant administration of ciclesonide nasal spray and azelastine nasal spray versus ciclesonide nasal spray alone in patients (18 years or older) with perennial allergic rhinitis (PAR) not adequately controlled on an intranasal corticosteroid or antihistamine monotherapy
* The secondary objective is to investigate the safety of the concomitant administration of ciclesonide nasal spray and azelastine nasal spray

Conditions

  • Rhinitis, Allergic, Perennial

Interventions

DRUG

Ciclesonide nasal spray + placebo Azelastine

Ciclesonide nasal spray 50 mcg + Placebo Azelastine

DRUG

Ciclesonide nasal spray + Azelastine

Ciclesonide nasal spray 50 mcg + Azelastine 137 mcg

Sponsors & Collaborators

Principal Investigators

  • AstraZeneca AstraZeneca · AstraZeneca

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-11-30
Primary Completion
2007-05-31
Completion
2007-08-31

Countries

  • United States

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 NCT00806754 on ClinicalTrials.gov