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

Covis Pharmaceuticals

Status and phase: Completed; Phase 4

Conditions: Allergic Rhinitis

Treatments: Drug: Ciclesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00458835

BY9010/M1-422

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

Ciclesonide 300 mcg intranasally via aqueous nasal spray

Active Comparator group

Treatment:

Drug: Ciclesonide

Ciclesonide 300 mcg intranasally via HFA nasal aerosol

Active Comparator group

Treatment:

Drug: Ciclesonide

Ciclesonide 320 mcg orally inhaled via HFA MDI

Active Comparator group

Treatment:

Drug: Ciclesonide