NCT00641212

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2000

Typical duration for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

3.2 years

First QC Date

March 18, 2008

Last Update Submit

March 24, 2009

Conditions

Perennial Allergic Rhinitis

Keywords

Allergic rhinitisPerennial allergic rhinitisPaediatricGrowthbudesonideRhinocort AQUA

Outcome Measures

Primary Outcomes (1)

  • Change in height over a 12 month period

    3 monthly

Secondary Outcomes (2)

  • Change in growth velocity over a 12 month period.

    3 monthly

  • Other safety - assessed by adverse event query

    3 monthly

Study Arms (2)

1

EXPERIMENTAL

Budesonide

Drug: Budesonide

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BudesonideDRUG
Also known as: Rhinocort AQUA
1
PlaceboDRUG
2

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic, PerennialRhinitis, Allergic

Interventions

Budesonide

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bertil Andersson

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 18, 2008

First Posted

March 24, 2008

Study Start

January 1, 2000

Primary Completion

April 1, 2003

Study Completion

April 1, 2003

Last Updated

March 25, 2009

Record last verified: 2009-03