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Study of the Effects of Ciclesonide Hydrofluoroalkane (HFA) Nasal Aerosol on Hypothalamic-Pituitary-Adrenal (HPA) Axis

NCT01033825 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2012-07-19

Study results available
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Summary

To demonstrate the effects of ciclesonide applied as a nasal aerosol and ciclesonide aqueous (AQ) nasal spray on hypothalamic-pituitary-adrenal axis.

Conditions

  • Perennial Allergic Rhinitis

Interventions

DRUG

Ciclesonide HFA Nasal Aerosol 320 mcg

Ciclesonide HFA Nasal Aerosol 320 μg once daily

DRUG

Ciclesonide HFA Nasal Aerosol 160 mcg

Ciclesonide HFA Nasal Aerosol 160 μg once daily

DRUG

HFA Nasal Aerosol placebo

HFA Nasal Aerosol placebo once daily

DRUG

Ciclesonide Aqueous Nasal Spray 200 mcg

Ciclesonide Aqueous Nasal Spray 200 mcg once daily

DRUG

AQ Nasal Spray Placebo

AQ Nasal Spray Placebo once daily

DRUG

Placebo plus Dexamethasone HFA

Dexamethasone capsules 6 mg once daily

DRUG

Placebo AQ plus Dexamethasone 6 mg

Placebo AQ plus Dexamethasone 6 mcg capsules once daily

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01033825 on ClinicalTrials.gov