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:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT01647633
Eligibility Criteria:
Inclusion Criteria:
* Male or Female 18-80 years of age
* Twelve months or more of allergic rhinitis symptoms
* Allergic antibodies to perennial aeroallergens to be confirmed by blood draw
Exclusion Criteria:
* Intranasal or systemic glucocorticosteroids within one month of study entry
* Intranasal cromolyn for 2 weeks prior to study
* Intranasal or systemic antihistamine for 3 days prior to the study
* Loratadine for ten days prior to study
* History of rhinitis medicamentosa
* Planned travel outside the study area that will inhibit study follow-up visits
\_Persons with Asthma with more than 2 episodes per week or month of nighttime awakenings
* Persons with Known sensitivity to Calcium or phosphorus supplements
* Persons taking antihistamine treatment intermittently. (Chronic steady use throughout study is acceptable)
* Immunomodulatory or cytotoxic drugs
* Clinically significant uncontrolled disease that in the opinion of the investigator would put the subject at risk or may confound the study interpretation
* Persons with hypercalcemia
* Persons whose nasal obstruction(s) would be significant to obstruct air flow
* Persons who are employees of Investigator or AkPharma or whose spouse, parent, child or sibling is employee of investigator
* Pregnant persons or persons planning to conceive/inseminate partner during study or for one month after
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01647633
Study Brief:
Protocol Section:
NCT01647633