Assess the Efficacy and Safety of Rhinocort Aqua
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel Group, Phase II Study to Assess the Efficacy and Safety of RHINOCORT AQUA (Budesonide) Nasal Spray 16mg, 32mg and 64mg Per Day Versus Placebo in Paediatric Subjects Ages 2-5 Years Old With Allergic Rhinitis.
2 other identifiers
interventional
650
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2004
Shorter than P25 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 18, 2008
CompletedFirst Posted
Study publicly available on registry
March 24, 2008
CompletedJanuary 24, 2011
January 1, 2011
1.1 years
March 18, 2008
January 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare Rhinocort with placebo to compare effects on nasal symptoms such as sneezing, runny and stuffy noses as assessed by caregivers.
At 2 weeks
Secondary Outcomes (2)
Safety assessment via adverse events and clinical measurements
At 1 & 2 weeks
To assess efficacy of Rhinocort via the physician and caregivers assessments
At 2 weeks
Study Arms (2)
1
EXPERIMENTALNasal Spray
2
PLACEBO COMPARATORInterventions
Eligibility Criteria
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 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Liza O'Dowd, MD
AstraZeneca
- STUDY DIRECTOR
Bertil Andersson
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
April 1, 2004
Primary Completion
May 1, 2005
Study Completion
May 1, 2005
Last Updated
January 24, 2011
Record last verified: 2011-01