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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00641212
First received: March 18, 2008
Last updated: March 24, 2009
Last verified: March 2009

March 18, 2008
March 24, 2009
January 2000
April 2003   (final data collection date for primary outcome measure)
Change in height over a 12 month period [ Time Frame: 3 monthly ]
Same as current
Complete list of historical versions of study NCT00641212 on ClinicalTrials.gov Archive Site
  • Change in growth velocity over a 12 month period. [ Time Frame: 3 monthly ]
  • Other safety - assessed by adverse event query [ Time Frame: 3 monthly ]
Same as current
Not Provided
Not Provided
 
Children, Perennial Allergic Rhinitis (PAR), l-t Growth
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.

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Perennial Allergic Rhinitis
  • Drug: Budesonide
    Other Name: Rhinocort AQUA
  • Drug: Placebo
  • Experimental: 1
    Budesonide
    Intervention: Drug: Budesonide
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
209
April 2003
April 2003   (final data collection date for primary outcome measure)

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.
Both
4 Years to 10 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00641212
SD-005-0414, D5360C00414
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: Bertil Andersson AstraZeneca
AstraZeneca
March 2009

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