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
  Purpose

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.


Condition Intervention Phase
Perennial Allergic Rhinitis
Drug: Budesonide
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in height over a 12 month period [ Time Frame: 3 monthly ]

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

Estimated Enrollment: 209
Study Start Date: January 2000
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Budesonide
Drug: Budesonide
Other Name: Rhinocort AQUA
Placebo Comparator: 2 Drug: Placebo

  Eligibility

Ages Eligible for Study:   4 Years to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641212

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Bertil Andersson AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00641212     History of Changes
Other Study ID Numbers: SD-005-0414, D5360C00414
Study First Received: March 18, 2008
Last Updated: March 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Allergic rhinitis
Perennial allergic rhinitis
Paediatric
Growth
budesonide
Rhinocort AQUA

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 29, 2014