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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-label, Single-dose, 3-period Crossover, Pharmacokinetic Study Designed to Compare the Systemic Des-ciclesonide Exposure of OMNARIS™ (Ciclesonide) Nasal Spray, Ciclesonide HFA Nasal Aerosol, and Orally Inhaled Ciclesonide

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Drug: Ciclesonide


Participation Criteria
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Eligibility Criteria
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Main 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ciclesonide 300 mcg intranasally via aqueous nasal spray<br> | Drug: Ciclesonide<br> <br> |
| Active Comparator: Ciclesonide 300 mcg intranasally via HFA nasal aerosol<br> | Drug: Ciclesonide<br> <br> |
| Active Comparator: Ciclesonide 320 mcg orally inhaled via HFA MDI<br> | Drug: Ciclesonide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 5min, 15min, 30min, 1h, 1.5h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 14h, 18h, 22h, 24h following drug administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergic rhinitis