New Nasal Applicator / New Formulation - User Study
Phase 2
Completed
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Drug: PlaceboDevice: Budesonide
- Registration Number
- NCT00641979
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to compare the efficacy of once daily dosing with Rhinocort Aqua (new formulation) against Rhinocort Aqua (current formulation) and placebo in reliving the symptoms of seasonal allergic rhinitis (SAR).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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 seasonal allergic rhinitis.
- A positive response to a skin prick test for grass allergens that must be present in the subject's environment throughout the study.
Exclusion Criteria
- 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 specified in the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Placebo - 1 Budesonide Rhinocort
- Primary Outcome Measures
Name Time Method Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing) 2 weekly
- Secondary Outcome Measures
Name Time Method Durability of device End of study Safety assessment via adverse events and clinical measurements 2 weekly