Status:
COMPLETED
Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)
Lead Sponsor:
Covis Pharma S.à.r.l.
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the systemic des-ciclesonide exposure of OMNARIS™ (ciclesonide) nasal spray, ciclesonide HFA nasal aerosol, and orally inhaled ciclesonide HFA-metered-dose inha...
Eligibility Criteria
Inclusion
- Main
- Written informed consent and HIPAA
- Body weight as indicate by a Body Mass Index (BMI) between ≥ 18 and ≤ 28 kg/m², and a body weight \>50 kg
- General good health
- Ability to use oral inhaler
- Main
Exclusion
- Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
- Participation in any investigational drug trial within the 30 days before Screening Visit and thereafter
- History or current clinically relevant allergies or idiosyncrasy to drugs or food
- History of allergic reactions to any corticosteroids including ciclesonide or any excipients of the formulations
- Any contraindication to nasally administered corticosteroids
- History of a respiratory infection or disorder \[including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, flu, severe acute respiratory syndrome (SARS)\] within the 30 days before Screening Visit, or development of a respiratory infection during the Screening Period
- History or current evidence of any other relevant allergic, cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, metabolic, neurological, psychiatric, or other disease within the last 2 years
- Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding Screening Visit
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00458835
Start Date
April 1 2007
End Date
April 1 2008
Last Update
February 9 2023
Active Locations (1)
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1
ALTANA Pharma
Austin, Texas, United States