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

Phase 4

Withdrawn

• Conditions: Allergic Rhinitis
• Interventions: Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide

• Registration Number: NCT00793858
• Lead Sponsor: University of Chicago

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-14
• Study First Submitted QC: 2008-11-18
• Study First Posted: 2008-11-19
• Study Start: 2009-02
• Primary Completion: 2009-09
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-06
• Last Update Posted: 2013-06-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
4	placebo, isotonic ciclesonide, hypotonic ciclesonide	isotonic ciclesonide in both right and left nostrils
1	placebo, isotonic ciclesonide, hypotonic ciclesonide	placebo in left nostril, isotonic ciclesonide in right
2	placebo, isotonic ciclesonide, hypotonic ciclesonide	hypotonic ciclesonide in left nostril, placebo in right
3	placebo, isotonic ciclesonide, hypotonic ciclesonide	hypotonic ciclesonide in right and left nostrils
6	placebo, isotonic ciclesonide, hypotonic ciclesonide	placebo in both right and left nostrils
5	placebo, isotonic ciclesonide, hypotonic ciclesonide	isotonic ciclesonide in left nostril and hypotonic ciclesonide in right

Primary Outcome Measures

Name	Time	Method
levels of ciclesonide in biopsy tissue	2 hours post study drug administration

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States