Assess the Efficacy and Safety of Rhinocort Aqua - Tabular View

Tracking Information

First Received Date ^ICMJE

March 18, 2008

Last Updated Date

March 24, 2009

Start Date ^ICMJE

April 2004

Primary Completion Date

May 2005 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00641693 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety assessment via adverse events and clinical measurements [ Time Frame: At 1 & 2 weeks ]
To assess efficacy of Rhinocort via the physician and caregivers assessments [ Time Frame: At 2 weeks ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Assess the Efficacy and Safety of Rhinocort Aqua

Official Title ^ICMJE

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.

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Allergic Rhinitis

Intervention ^ICMJE

Drug: Budesonide
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Nasal Spray

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

650

Completion Date

May 2005

Primary Completion Date

May 2005 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

2 Years to 5 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00641693

Responsible Party

Study ID Numbers ^ICMJE

D5360C00703, SD-005-0703

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:	Liza O'Dowd, MD	AstraZeneca
Study Director:	Bertil Andersson	AstraZeneca

Information Provided By

AstraZeneca

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP