Assess the Efficacy and Safety of Rhinocort Aqua

AstraZeneca

Status and phase

Completed

Phase 2

Conditions

Allergic Rhinitis

Treatments

Drug: Budesonide

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00641693

D5360C00703

SD-005-0703

Details and patient eligibility

About

The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.

Enrollment

650 estimated patients

Sex

All

Ages

2 to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

In the opinion of the investigator, is a candidate for treatment with nasal steroids based on a history of either a) inadequate control of symptoms with antihistamines, decongestants and/or immunotherapy, or b) prior successful treatment with nasal steroids.
A documented history of allergic rhinitis and a positive response to a skin prick test at Visit 1 or within the last 12 months for allergens that must be present in the subject's environment for the duration of the study.
At randomisation having nasal symptom scores as defined by the protocol.

Exclusion criteria

Primary or secondary adrenal insufficiency
Nasal candidiasis, rhinitis medicamentosa, acute or chronic sinusitis, influenza, upper respiratory tract infection or structural abnormalities of the nose (e.g., septal deviation, nasal polyps) symptomatic enough to cause significant nasal obstruction as judged by the investigator.
A diagnosis of asthma requiring treatment as specifies in the protocol.