Study Stopped
Cost prohibitive and company withdrew support.
A Pilot Investigation of Ciclesonide When Administered as a Hypotonic Versus an Isotonic Formulation of Ciclesonide Nasal Spray
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).
1 other identifier
interventional
N/A
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2008
CompletedFirst Posted
Study publicly available on registry
November 19, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedJune 7, 2013
June 1, 2013
7 months
November 14, 2008
June 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
levels of ciclesonide in biopsy tissue
2 hours post study drug administration
Study Arms (6)
1
ACTIVE COMPARATORplacebo in left nostril, isotonic ciclesonide in right
2
ACTIVE COMPARATORhypotonic ciclesonide in left nostril, placebo in right
3
ACTIVE COMPARATORhypotonic ciclesonide in right and left nostrils
4
ACTIVE COMPARATORisotonic ciclesonide in both right and left nostrils
6
PLACEBO COMPARATORplacebo in both right and left nostrils
5
ACTIVE COMPARATORisotonic ciclesonide in left nostril and hypotonic ciclesonide in right
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Chicagolead
- Sumitomo Pharma America, Inc.collaborator
Study Sites (1)
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 14, 2008
First Posted
November 19, 2008
Study Start
February 1, 2009
Primary Completion
September 1, 2009
Last Updated
June 7, 2013
Record last verified: 2013-06