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

Allergic Rhinitis Clinical Trial

Official title:

A Pilot Investigation of the Nasal Mucosal Absorption, Retention, and Metabolism of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray When Each Formulation Is Administered to Currently Symptomatic Patients (18 Years or Older) With Documented Perennial Allergic Rhinitis (PAR).

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00793858
• Other study ID #: 16651A (SEP 1)
• Status: Withdrawn
• Phase: Phase 4
• First received: November 14, 2008
• Last updated: June 6, 2013
• Start date: February 2009

Study information

• Verified date: June 2013
• Source: University of Chicago
• 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 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• placebo, isotonic ciclesonide, hypotonic ciclesonide
200mcg/nostril

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Chicago	Sunovion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	levels of ciclesonide in biopsy tissue		2 hours post study drug administration	No