New Nasal Applicator / New Formulation - User Study
Study identifier:SD-005-0698
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
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).
Medical condition
Seasonal Allergic Rhinitis
Phase
Phase 2
Healthy volunteers
No
Study drug
budesonide, Placebo
Sex
All
Actual Enrollment
200
Study type
Interventional
Age
6 Years - 99 Years
Date
Study Start Date: 01 Apr 2002
Primary Completion Date: 01 Aug 2002
Study Completion Date: 01 Aug 2002
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Rhinocort | Drug: budesonide Current product Other Name: Rhinocort AQUA Device: Budesonide New type device Other Name: Rhinocort Aqua |
| Placebo Comparator: 2 | - |
Contacts
Investigators
Principal Investigator
Shaile Shah
Allergy & Asthma Consultant, NJ, USA.
