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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT00712920
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients 12 years of age and older
* Must be in generally good health
* Must meet minimum symptom requirements, as specified in protocol
* Must be willing and able to provide informed consent and participate in all study procedures
* 2-year history of PAR
* Positive skin test to cockroach, dust mite, mold or cat/dog dander
Exclusion Criteria:
* On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
* Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
* Nasal surgery or sinus surgery within the previous year
* The use of any investigational drug within 30 days
* Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
* Women who are pregnant or nursing
* Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
* Respiratory tract infection within 2 weeks of screening
* Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
* Patients with asthma with the exception of mild, intermittent
* Significant pulmonary disease including COPD
* Patients with arrhythmia
* Patients with a known history of alcohol or drug abuse
* Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
* Clinically relevant abnormal physical findings within one week of randomization
* Overnight abscences from home for more than 3 nights
* Employees of the research center or private practice and family members are excluded
* Patients who received prohibited medications within specified timepoints in protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00712920
Study Brief:
Protocol Section:
NCT00712920