Children, Perennial Allergic Rhinitis (PAR), l-t Growth - Tabular View

Tracking Information

First Received Date ^ICMJE

March 18, 2008

Last Updated Date

March 24, 2009

Start Date ^ICMJE

January 2000

Primary Completion Date

April 2003 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in height over a 12 month period [ Time Frame: 3 monthly ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00641212 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in growth velocity over a 12 month period. [ Time Frame: 3 monthly ]
Other safety - assessed by adverse event query [ Time Frame: 3 monthly ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Children, Perennial Allergic Rhinitis (PAR), l-t Growth

Official Title ^ICMJE

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Effect of Long-Term Treatment With Rhinocort Aqua (Budesonide) Nasal Spray in Children With Perennial Allergic Rhinitis.

Brief Summary

The purpose of this study is to compare the effect of Rhinocort nasal spray with placebo on growth in children with perennial allergic rhinitis over 12 months.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Perennial Allergic Rhinitis

Intervention ^ICMJE

Drug: Budesonide
Drug: Placebo

Study Arms / Comparison Groups

Experimental: Budesonide

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

209

Completion Date

April 2003

Primary Completion Date

April 2003 (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 at least one year of perennial allergic rhinitis.
A positive response to a skin prick test for perennial allergens that must be present in the subject's environment.
Height and weight within normal limits.

Exclusion Criteria:

Any disease which may affect growth
Sexual development later than Tanner stage I.
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.

Gender

Both

Ages

4 Years to 10 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

NCT00641212

Responsible Party

Study ID Numbers ^ICMJE

SD-005-0414, D5360C00414

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

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