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

Sponsors and Collaborators:	University of Chicago Sepracor, Inc.
Information provided by:	University of Chicago
ClinicalTrials.gov Identifier:	NCT00793858

Purpose

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

Condition	Intervention	Phase
Allergic Rhinitis	Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide	Phase IV

Drug Information available for: Ciclesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Single Blind (Subject), Single Group Assignment
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).

Further study details as provided by University of Chicago:

Primary Outcome Measures:

levels of ciclesonide in biopsy tissue [ Time Frame: 2 hours post study drug administration ] [ Designated as safety issue: No ]

Estimated Enrollment:	13
Study Start Date:	February 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator placebo in left nostril, isotonic ciclesonide in right	Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide 200mcg/nostril
2: Active Comparator hypotonic ciclesonide in left nostril, placebo in right	Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide 200mcg/nostril
3: Active Comparator hypotonic ciclesonide in right and left nostrils	Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide 200mcg/nostril
4: Active Comparator isotonic ciclesonide in both right and left nostrils	Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide 200mcg/nostril
6: Placebo Comparator placebo in both right and left nostrils	Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide 200mcg/nostril
5: Active Comparator isotonic ciclesonide in left nostril and hypotonic ciclesonide in right	Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide 200mcg/nostril

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females 18 years of age or older.
History of perennial allergic rhinitis for at least 1 year prior to screening.
Positive skin test to perennial allergen.

Exclusion Criteria:

Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
Pregnant or lactating women.
Upper respiratory infection within 14 days of study start.
Active asthma requiring treatment with inhaled or systemic steroids.
Use of any form of nasal spray during the previous month.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00793858

Contacts

Contact: Marcy deTineo, BSN

773-702-5889

Locations

United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637

Sponsors and Collaborators

University of Chicago

Sepracor, Inc.

More Information

Responsible Party:	University of Chicago ( Robert Naclerio, MD )
Study ID Numbers:	16651A (SEP 1)
Study First Received:	November 14, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00793858
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Perennial

Ciclesonide
Rhinitis
Urinary Retention

Additional relevant MeSH terms:

Therapeutic Uses
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on January 15, 2009