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

This study has been completed.
Information provided by (Responsible Party):
Takeda Identifier:
First received: April 10, 2007
Last updated: May 4, 2012
Last verified: January 2012

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.

Condition Intervention Phase
Allergic Rhinitis
Drug: Ciclesonide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Takeda:

Primary Outcome Measures:
  • To compare the systemic exposure to des-ciclesonide with OMNARIS™ (ciclesonide nasal spray), and ciclesonide HFA nasal aerosol and orally inhaled ciclesonide.

Secondary Outcome Measures:
  • Pharmacokinetic parameters, safety and tolerability of ciclesonide will also be assessed.

Estimated Enrollment: 30
Study Start Date: April 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00458835

United States, Texas
Austin, Texas, United States
Sponsors and Collaborators
Principal Investigator: Aziz L Laurent, MD PPD Development, LP, Austin , TX 78744
  More Information

No publications provided by Takeda

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Takeda Identifier: NCT00458835     History of Changes
Other Study ID Numbers: BY9010/M1-422
Study First Received: April 10, 2007
Last Updated: May 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Takeda:
Allergic rhinitis

Additional relevant MeSH terms:
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 23, 2014