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

June 6, 2013 updated by: University of Chicago

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).

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
levels of ciclesonide in biopsy tissue
Time Frame: 2 hours post study drug administration
2 hours post study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

Sunovion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Anticipated)

September 1, 2009

Study Registration Dates

First Submitted

November 14, 2008

First Submitted That Met QC Criteria

November 18, 2008

First Posted (Estimate)

November 19, 2008

Study Record Updates

Last Update Posted (Estimate)

June 7, 2013

Last Update Submitted That Met QC Criteria

June 6, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16651A (SEP 1)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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