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

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

Collaborators

Inclusion and exclusion criteria

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	-

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1104&filename=CSR-SD-005-0698.pdf
Download
CSR-SD-005-0698.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

null AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Investigators

Principal Investigator

Shaile Shah

Allergy & Asthma Consultant, NJ, USA.