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Safety and Effectiveness of Ciclesonide Nasal Spray in Patients With Perennial Allergic Rhinitis During One Year Treatment (BY9010/M1-404)

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AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Perennial Allergic Rhinitis
Allergic Rhinitis
Hay Fever

Treatments

Drug: Ciclesonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00163501
BY9010/M1-404

Details and patient eligibility

About

The purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of perennial allergic rhinitis.

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

  • General good health, other than perennial allergic rhinitis
  • History and diagnosis of perennial allergic rhinitis by skin prick test

Main Exclusion Criteria:

  • Participation in any investigational drug trial within the 30 days preceding the Screening Visit
  • A known hypersensitivity to any corticosteroid or any of the excipients in the formulation
  • Use of any prohibited concomitant medications as defined by the study protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

Trial contacts and locations

41

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Data sourced from clinicaltrials.gov

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