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Ciclesonide Nasal Spray for Seasonal Allergic Rhinitis
NCT00659841Phase 3
Key facts
- Status
- Completed
- Start
- Dec 2003
- Primary completion
- Dec 2004
- Countries
- 1
- Sponsor
- AstraZeneca
- Modality
- Orthosteric Ligands
- Drugs
- ciclesonide
- Conditions
- seasonal allergic rhinitis (SAR)
01
Overview
Phase 3, randomised, double-blind trial in seasonal allergic rhinitis (SAR) comparing Ciclesonide 200µg with Placebo (2 arms). Primary endpoint: Total Nasal Symptom Score at 2 weeks. Started Dec 2003; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ciclesonide 200µg
Ciclesonide nasal spray 200µg once daily
Placebo
Placebo nasal spray once daily
03
Who it enrols
Patients 12 years and older with a 2-year history of seasonal allergic rhinitis and demonstrated sensitivity to Mountain Cedar pollen.
04
Endpoints
Primary
Total Nasal Symptom Score
Secondary
Instantaneous Total Nasal Symptom Score
Physician Assessment of Overall Nasal Signs and Symptoms Severity
Rhinoconjunctivitis Quality of Life Questionnaire
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