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NCT00641979 Clinical Trial

New Nasal Applicator / New Formulation - User Study

Seasonal Allergic Rhinitis Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00641979
Other study ID # SD-005-0698
Secondary ID D5360C00698
Status Completed
Phase Phase 2
First received March 18, 2008
Last updated January 21, 2011
Start date April 2002
Est. completion date August 2002

Study information
Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 2002
Est. primary completion date August 2002
Accepts healthy volunteers No
Gender Both
Age group 6 Years and older
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• budesonide
Current product
Device:
• Budesonide
New type device
Drug:
• Placebo

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary Assessment of Total Nasal Symptom scores (Rhinorrhea, Congestion, Itching & Sneezing) 2 weekly
Secondary Durability of device End of study
Secondary Safety assessment via adverse events and clinical measurements 2 weekly
See also
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