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 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
NCT ID:
NCT01630135
Eligibility Criteria:
Inclusion Criteria:
* Informed Consent
* 6 to \<15 years of age, male or eligible female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control), outpatient
* Diagnosis of perennial allergic rhinitis: A positive test response to house dust and/or dust mites on serum antigen-specific IgE antibody test at Visit 1. One year or more clinical history of perennial allergic rhinitis. A positive test result on nasal eosinophil count at Visit 1/1A.
* Either subject's parent/guardian who signed ICF or subject is able to complete assessments on the patient diary through the study.
* ALT \< 2xULN; alkaline phosphatase and bilirubin \<= 1.5xULN
* Average of 3TNSS is \>= 4.0 in the last consecutive 4 days prior to Visit 2.
* Completion of the patient diary on \>= 3 days of the last consecutive 4 days prior to Visit 2
Exclusion Criteria:
* Has a seasonal pollen as an allergen
* A nose disorder that could affect the assessment of the study medication or eye or nose surgery (within 3 months prior to Visit 1)
* Bacterial or viral infection of upper respiratory tract or eye
* Concurrent disease/abnormalities: Clinically significant uncontrolled disease
* Known hypersensitivity to corticosteroids or any excipients in the investigational product
* Has recent participation in a study and/or exposure to an investigational study drug within 3 months prior to Visit 1
* Use of the following medication and/or its combination drug within the specified time:
Anti-IgE (Within 6 months prior to Visit 1), Immunosuppressive medications or Systemic corticosteroids (Within 8 weeks prior to Visit 1), Topical corticosteroids (Within 4 weeks prior to Visit 1), Immunotherapy or nonspecific allassotherapy which was initiated, discontinued or changed its dose within 4 weeks prior to Visit 1
* Affiliation with Investigator's Site: Relative or employee
* History of alcohol or drug abuse, children in care or in the opinion of the investigator (sub-investigator), inappropriate to be enrolled in the study.
* Average of 3TNSS is \>= 8.0 in the last consecutive 4 days prior to Visit 2.
* Bacterial or viral infection of upper respiratory tract or eye during the screening period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
14 Years
Study:
NCT01630135
Study Brief:
Protocol Section:
NCT01630135