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

This study has been withdrawn prior to enrollment.
(Cost prohibitive and company withdrew support.)
Sponsor:
Collaborator:
Sunovion
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00793858
First received: November 14, 2008
Last updated: July 16, 2010
Last verified: July 2010
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
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).

Resource links provided by NLM:

Drug Information available for: Ciclesonide
U.S. FDA Resources

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

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

Locations
United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Sunovion
  More Information

No publications provided

Responsible Party: Robert Naclerio, MD, University of Chicago
ClinicalTrials.gov Identifier: NCT00793858     History of Changes
Other Study ID Numbers: 16651A (SEP 1)
Study First Received: November 14, 2008
Last Updated: July 16, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Ciclesonide
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013