Overview

A Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to measure the amount of a nasal steroid spray (ciclesonide) absorbed by the tissue in the nose 2 hours after having this study drug sprayed in the nose
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Chicago
Collaborator:
Sunovion
Treatments:
Ciclesonide
Criteria
Inclusion Criteria:

1. Males and females 18 years of age or older.

2. History of perennial allergic rhinitis for at least 1 year prior to screening.

3. Positive skin test to perennial allergen.

Exclusion Criteria:

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.

2. Pregnant or lactating women.

3. Upper respiratory infection within 14 days of study start.

4. Active asthma requiring treatment with inhaled or systemic steroids.

5. Use of any form of nasal spray during the previous month.