Assess the Efficacy and Safety of Rhinocort Aqua

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00641693

Enrollment

650

Registered

2008-03-24

Start date

2004-04-30

Completion date

2005-05-31

Last updated

2011-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis, Paediatric, Nasal symptoms, Congestion, Rhinorrhea, Sneeze, budesonide, Rhinocort AQUA

Brief summary

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.

Interventions

DRUGBudesonide

16mg Nasal Spray

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

2 Years to 5 Years

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.

Design outcomes

Primary

Measure	Time frame
To compare Rhinocort with placebo to compare effects on nasal symptoms such as sneezing, runny and stuffy noses as assessed by caregivers.	At 2 weeks

Secondary

Measure	Time frame
Safety assessment via adverse events and clinical measurements	At 1 & 2 weeks
To assess efficacy of Rhinocort via the physician and caregivers assessments	At 2 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026