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

The University of Chicago

Status and phase: Withdrawn; Phase 4

Conditions: Allergic Rhinitis

Treatments: Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00793858

16651A (SEP 1)

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

---

0 participants in 6 patient groups, including a placebo group

1

Active Comparator group

Description:

placebo in left nostril, isotonic ciclesonide in right

Treatment:

Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide

2

Active Comparator group

Description:

hypotonic ciclesonide in left nostril, placebo in right

Treatment:

Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide

3

Active Comparator group

Description:

hypotonic ciclesonide in right and left nostrils

Treatment:

Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide

4

Active Comparator group

Description:

isotonic ciclesonide in both right and left nostrils

Treatment:

Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide

6

Placebo Comparator group

Description:

placebo in both right and left nostrils

Treatment:

Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide

5

Active Comparator group

Description:

isotonic ciclesonide in left nostril and hypotonic ciclesonide in right

Treatment:

Drug: placebo, isotonic ciclesonide, hypotonic ciclesonide