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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00458835
First received: April 10, 2007
Last updated: May 4, 2012
Last verified: January 2012
  Purpose

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)
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00458835

Locations
United States, Texas
ALTANA Pharma
Austin, Texas, United States
Sponsors and Collaborators
Takeda
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeda
ClinicalTrials.gov 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:
Rhinitis
Rhinitis, Allergic, Perennial
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Respiratory Tract Infections
Ciclesonide
Anti-Allergic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014