Status:
COMPLETED
Assess the Efficacy and Safety of Rhinocort Aqua
Lead Sponsor:
AstraZeneca
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
2-5 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to compare Rhinocort with placebo in pediatric subjects aged 2-5 years with allergic rhinitis to study effects on nasal symptoms such as sneezing, runny and stuffy noses.
Eligibility Criteria
Inclusion
- 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 allergic rhinitis and a positive response to a skin prick test at Visit 1 or within the last 12 months for allergens that must be present in the subject's environment for the duration of the study.
- At randomisation having nasal symptom scores as defined by the protocol.
Exclusion
- Primary or secondary adrenal insufficiency
- 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.
- A diagnosis of asthma requiring treatment as specifies in the protocol.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2005
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT00641693
Start Date
April 1 2004
End Date
May 1 2005
Last Update
January 24 2011
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