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

NCT ID: NCT00458835

Last Updated: 2023-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2008-04-30

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.

Conditions

Allergic Rhinitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ciclesonide 300 mcg intranasally via aqueous nasal spray

Group Type: ACTIVE_COMPARATOR

Ciclesonide

Intervention Type: DRUG

Ciclesonide 300 mcg intranasally via HFA nasal aerosol

Group Type: ACTIVE_COMPARATOR

Ciclesonide

Intervention Type: DRUG

Ciclesonide 320 mcg orally inhaled via HFA MDI

Group Type: ACTIVE_COMPARATOR

Ciclesonide

Intervention Type: DRUG

Interventions

Ciclesonide

Intervention Type: DRUG

Eligibility Criteria

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Covis Pharma S.à.r.l.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AstraZeneca AstraZeneca

Role: STUDY_DIRECTOR

AstraZeneca

Locations

ALTANA Pharma

Austin, Texas, United States

Countries

United States

References

Nave R, Herzog R, Laurent A, Wingertzahn MA. 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. Clin Ther. 2009 Dec;31(12):2988-99. doi: 10.1016/j.clinthera.2009.12.002.

Reference Type: DERIVED

PMID: 20110036 (View on PubMed)

Other Identifiers

BY9010/M1-422

Identifier Type: -

Identifier Source: org_study_id