Phase 4
Completed N=30
Comparison Between Systemic Exposure to Ciclesonide Nasal Spray, Ciclesonide HFA Nasal Aerosol and Orally Inhaled Ciclesonide (BY9010/M1-422)
Source: ClinicalTrials.gov NCT00458835 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcomePrimary: 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. — NA; 403.7; 2762 ng*hr/L
◆ Published Evidence
Emerging
15citations · ~1 / year
Pharmacokinetics of ciclesonide and desisobutyryl ciclesonide after administration via aqueous nasal spray or hydrofluoroalkane nasal aerosol compared with orally inhaled ciclesonide: an open-label, single-dose, three-period crossover study in healthy volunteers.
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.
Linked Publications
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Pharmacokinetics of ciclesonide and desisobutyryl ciclesonide after administration via aqueous nasal spray or hydrofluoroalkane nasal aerosol compared with orally inhaled ciclesonide: an open-label, single-dose, three-period crossover study in healthy volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
NA; 403.7; 2762 | — |
| SECONDARY 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. |
20.05; 59.0; 602.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00458835) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.