NCT00305487CompletedPhase 3
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial Designed to Assess the Safety and Efficacy of Ciclesonide (200mcg and 100mcg, Once Daily) Applied as a Nasal Spray for Two Weeks in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 6 to 11 Years of Age
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 660
- Locations
- 72
- Primary Endpoint
- Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment
Study Overview
Brief Summary
The aim of the study is to determine the efficacy and safety of ciclesonide nasal spray in children with seasonal allergic rhinitis. Ciclesonide will be administered intranasally at two dose levels once daily. The study consists of a baseline period (1 to 3 weeks) and a treatment period (2 weeks).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 6 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Main Inclusion Criteria:
- •Written informed consent
- •General good health other than seasonal allergic rhinitis
- •Positive standard skin prick test
Exclusion Criteria
- •Pregnancy, nursing, or plans to become pregnant or donate gametes for in vitro fertilization
- •Participation in any investigational drug trial within the 30 days preceding the Screening Visit
- •A known hypersensitivity to any corticosteroid or any of the ingredients in the study drug formulation
- •Plans to travel outside the study area (the known pollen area for the investigative site) for 24 hours or more during the final 7 days of the baseline period
- •Plans to travel outside the study area (the known pollen area for the investigative site) for more than 2 consecutive days OR more than 3 days total during the treatment period
- •Use of any prohibited concomitant medications
- •Non-vaccinated exposure to or active infection with chickenpox or measles within the 21 days preceding the Screening Visit
- •Use of antiepileptic drugs for epilepsy within 30 days of the Screening Visit
- •Study participation by more than one patient from the same household
Outcomes
Primary Outcomes
Average of morning and evening parent/caregiver reported reflective total nasal symptoms score over the two weeks of treatment
Secondary Outcomes
- Physician assessment of nasal symptoms score at endpoint
- safety
- average of morning and evening parent/caregiver reported instantaneous total nasal symptom score over the two weeks of treatment
Investigators
Study Sites (72)
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