Assess the Efficacy and Safety of Rhinocort Aqua

Condition(s) targeted: Allergic Rhinitis

Intervention: Budesonide (Drug); Budesonide (Drug); Budesonide (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Liza O'Dowd, MD, Study Director, Affiliation: AstraZeneca
Bertil Andersson, Study Director, Affiliation: AstraZeneca

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.

Official title: A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Phase II Study to Assess the Efficacy and Safety of RHINOCORT AQUA (Budesonide) Nasal Spray 16mg, 32mg and 64mg Per Day Versus Placebo in Paediatric Subjects Ages 2-5 Years Old With Allergic Rhinitis.

Study design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To compare Rhinocort with placebo to compare effects on nasal symptoms such as sneezing, runny and stuffy noses as assessed by caregivers.

Secondary outcome:

Safety assessment via adverse events and clinical measurements

To assess efficacy of Rhinocort via the physician and caregivers assessments

Minimum age: 2 Years. Maximum age: 5 Years. Gender(s): Both.

Criteria:

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.

Starting date: April 2004
Ending date: June 2005
Last updated: March 18, 2008