Back to resultsA Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray
Primary Purpose
Allergic Rhinitis
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
placebo, isotonic ciclesonide, hypotonic ciclesonide
Sponsored by
About this trial
This is an interventional basic science trial for Allergic Rhinitis
Eligibility 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.
Sites / Locations
- University of Chicago Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Arm Label
1
2
3
4
6
5
Arm Description
placebo in left nostril, isotonic ciclesonide in right
hypotonic ciclesonide in left nostril, placebo in right
hypotonic ciclesonide in right and left nostrils
isotonic ciclesonide in both right and left nostrils
placebo in both right and left nostrils
isotonic ciclesonide in left nostril and hypotonic ciclesonide in right
Outcomes
Primary Outcome Measures
levels of ciclesonide in biopsy tissue
Secondary Outcome Measures
Full Information
NCT ID
NCT00793858
First Posted
November 14, 2008
Last Updated
June 6, 2013
Sponsor
University of Chicago
Collaborators
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00793858
Brief Title
A Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray
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).
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Cost prohibitive and company withdrew support.
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2009 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
placebo in left nostril, isotonic ciclesonide in right
Arm Title
2
Arm Type
Active Comparator
Arm Description
hypotonic ciclesonide in left nostril, placebo in right
Arm Title
3
Arm Type
Active Comparator
Arm Description
hypotonic ciclesonide in right and left nostrils
Arm Title
4
Arm Type
Active Comparator
Arm Description
isotonic ciclesonide in both right and left nostrils
Arm Title
6
Arm Type
Placebo Comparator
Arm Description
placebo in both right and left nostrils
Arm Title
5
Arm Type
Active Comparator
Arm Description
isotonic ciclesonide in left nostril and hypotonic ciclesonide in right
Intervention Type
Drug
Intervention Name(s)
placebo, isotonic ciclesonide, hypotonic ciclesonide
Intervention Description
200mcg/nostril
Primary Outcome Measure Information:
Title
levels of ciclesonide in biopsy tissue
Time Frame
2 hours post study drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray
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