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 @ 11:19 PM
Ignite Modification Date:
2025-12-24 @ 11:19 PM
NCT ID:
NCT01697956
Eligibility Criteria:
Inclusion Criteria:
* Informed consent/(assent - if applicable)
* Male or female subjects 6-11 years of age
* General good health
* A documented history of PAR to a relevant perennial allergen for a minimum of 12 months
* Other criteria apply
Exclusion Criteria:
* Pregnancy, nursing, or plans to become pregnant or donate gametes
* Participation in any investigational drug study within the 30 days preceding the Screening Visit 1 (SV1)
* Previous participation in a BDP nasal aerosol study as a randomized subject
* A known hypersensitivity to any corticosteroid or any of the excipients in the study medication formulation
* History of physical findings of nasal pathology, including nasal polyps or other clinically significant respiratory tract malformations
* History of a respiratory infection or disorder within the 14 days preceding the Screening Visit 1 (SV1)
* Use of any prohibited concomitant medications within the prescribed (per protocol) withdrawal periods prior to the Screening Visit 1 (SV1)
* Other criteria apply
* Current smoker or current user of tobacco products at any time during the study; history of smoking or use of tobacco products within the past year
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
11 Years
Study:
NCT01697956
Study Brief:
Protocol Section:
NCT01697956