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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Brief Summary

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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

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Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

placebo in left nostril, isotonic ciclesonide in right

Group Type ACTIVE_COMPARATOR

placebo, isotonic ciclesonide, hypotonic ciclesonide

Intervention Type DRUG

200mcg/nostril

2

hypotonic ciclesonide in left nostril, placebo in right

Group Type ACTIVE_COMPARATOR

placebo, isotonic ciclesonide, hypotonic ciclesonide

Intervention Type DRUG

200mcg/nostril

3

hypotonic ciclesonide in right and left nostrils

Group Type ACTIVE_COMPARATOR

placebo, isotonic ciclesonide, hypotonic ciclesonide

Intervention Type DRUG

200mcg/nostril

4

isotonic ciclesonide in both right and left nostrils

Group Type ACTIVE_COMPARATOR

placebo, isotonic ciclesonide, hypotonic ciclesonide

Intervention Type DRUG

200mcg/nostril

6

placebo in both right and left nostrils

Group Type PLACEBO_COMPARATOR

placebo, isotonic ciclesonide, hypotonic ciclesonide

Intervention Type DRUG

200mcg/nostril

5

isotonic ciclesonide in left nostril and hypotonic ciclesonide in right

Group Type ACTIVE_COMPARATOR

placebo, isotonic ciclesonide, hypotonic ciclesonide

Intervention Type DRUG

200mcg/nostril

Interventions

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placebo, isotonic ciclesonide, hypotonic ciclesonide

200mcg/nostril

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No