Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:42 PM
Ignite Modification Date:
2025-12-24 @ 10:42 PM
NCT ID:
NCT00458835
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00458835
Study Brief:
Protocol Section:
NCT00458835