Back to resultsChildren, Perennial Allergic Rhinitis (PAR), l-t Growth
Primary Purpose
Perennial Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Budesonide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Perennial Allergic Rhinitis focused on measuring Allergic rhinitis, Perennial allergic rhinitis, Paediatric, Growth, budesonide, Rhinocort AQUA
Eligibility 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 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Budesonide
Outcomes
Primary Outcome Measures
Change in height over a 12 month period
Secondary Outcome Measures
Change in growth velocity over a 12 month period.
Other safety - assessed by adverse event query
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00641212
Brief Title
Children, Perennial Allergic Rhinitis (PAR), l-t Growth
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
April 2003 (Actual)
Study Completion Date
April 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perennial Allergic Rhinitis
Keywords
Allergic rhinitis, Perennial allergic rhinitis, Paediatric, Growth, budesonide, Rhinocort AQUA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
209 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Budesonide
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Budesonide
Other Intervention Name(s)
Rhinocort AQUA
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Change in height over a 12 month period
Time Frame
3 monthly
Secondary Outcome Measure Information:
Title
Change in growth velocity over a 12 month period.
Time Frame
3 monthly
Title
Other safety - assessed by adverse event query
Time Frame
3 monthly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bertil Andersson
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Children, Perennial Allergic Rhinitis (PAR), l-t Growth
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