NCT00641979CompletedPhase 2
A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Functionality of a New Nasal Device With Reformulated Rhinocort Aqua (Budesonide) Versus the Current Product and Versus Placebo in Subjects With Seasonal Allergic Rhinitis (SAR).
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 200
- Primary Endpoint
- Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
2
Placebo Comparator
Intervention: Placebo (Drug)
1
Experimental
Rhinocort
Intervention: Budesonide (Device)
Outcomes
Primary Outcomes
Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing)
Time Frame: 2 weekly
Secondary Outcomes
- Durability of device(End of study)
- Safety assessment via adverse events and clinical measurements(2 weekly)
Investigators
Similar Trials
Completed
Phase 3
Rhinocort Aqua Versus Placebo and Fluticasone PropionateSeasonal Allergic RhinitisNCT00641680AstraZeneca750
Completed
Phase 4
Children, Perennial Allergic Rhinitis (PAR), l-t GrowthPerennial Allergic RhinitisNCT00641212AstraZeneca209
Completed
Phase 2
Assess the Efficacy and Safety of Rhinocort AquaAllergic RhinitisNCT00641693AstraZeneca650
Completed
Phase 2
Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Grass Pollen AllergyRhinoconjunctivitisRhinitisNCT02654223Inmunotek S.L.180
Unknown
Phase 2
Dose Finding for the Treatment of Rhinitis/Rhinoconjunctivitis Against Mite AllergyRhinoconjunctivitisRhinitisNCT02661854Inmunotek S.L.186