Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)

Phase 4

Completed

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 inhaler (MDI). The administration of the study medication will be as follows: three single doses, separated by a wash-out period. The study will provide further data on the safety and tolerability of ciclesonide.

Recruitment & Eligibility

Inclusion Criteria

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 Criteria

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

Arm && Interventions

Group	Intervention	Description
Ciclesonide 300 mcg intranasally via aqueous nasal spray	Ciclesonide	-
Ciclesonide 300 mcg intranasally via HFA nasal aerosol	Ciclesonide	-
Ciclesonide 320 mcg orally inhaled via HFA MDI	Ciclesonide	-

Primary Outcome Measures

Name	Time	Method
Comparison of Systemic Exposure Measured by AUC, ng*hr/L, (Area Under the Serum Concentration) of Des-ciclesonide With Ciclesonide Nasal Spray, and Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide.	5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration.	The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARIS™ \[ciclesonide\] nasal spray and 300 mcg ciclesonide nasal HFA aerosol vs. 320 mcg orally inhaled ciclesonide as a reference. At prespecified timepoints, blood samples were obtained from subjects. It was anticipated that only a limited number of des-ciclesonide concentrations would exceed the lower limit of quantification (LLOQ) of 10 pg/mL for ciclesonide aqueous nasal spray. AUC for the aqueous nasal spray could not be determined due to the fact that there were too few analysis samples that produced values above the LLOQ.

Secondary Outcome Measures

Name	Time	Method
Comparison of Systemic Exposure Measured by Cmax, pg/mL, (Highest Concentration of Drug in the Blood) of Des-ciclesonide With Ciclesonide Nasal Spray, and Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide.	5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration.	The primary pharmacokinetics comparisons between treatments will be that of 300 mcg OMNARIS™ \[ciclesonide\] nasal spray and 300 mcg ciclesonide nasal HFA aerosol vs. 320 mcg orally inhaled ciclesonide as a reference. At prespecified timepoints, blood samples were obtained from subjects. The Cmax may be available only for a limited number of subjects. Thus the focus of statistical PK analysis will be on descriptive statistics. In particular, mean and median for Cmax will be calculated using data from subjects with Cmax above LLOQ (Lower Limit of Quantitation) and from all subjects with Cmax below LLOQ imputed by 0.