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 @ 4:59 AM
Ignite Modification Date:
2025-12-25 @ 4:59 AM
NCT ID:
NCT00651118
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
* Must be in generally good health
* Must meet minimum symptom requirements, as specified in the protocol
* Must be wiling and able to provide informed consent and to participate all study procedures
* Positive skin test to a prevalent spring allergen
Exclusion criteria:
* On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation
* Nasal disease likely to affect the deposition of the medication or evaluation, such as sinus infection, nasal polyps or severe deviated septum
* Nasal or sinus surgery within the previous 6 months
* Chronic sinus infection (more than 3 per year)
* Planned travel outside the study area during the study period
* Use of any investigational drug within 30 days of the first visit
* Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or fluticasone propionate nasal spray (Flonase)
* Women who are not using an acceptable method or birth control
* Women who are pregnant or nursing
* Upper respiratory tract infection such as common cold, flu, sinus infection within 2 weeks of first study visit
* Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with the investigator
* Irregular heartbeat or other symptomatic heart conditions
* History of alcohol or drug abuse
* History of glaucoma
* Use of medications that could affect the study results
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00651118
Study Brief:
Protocol Section:
NCT00651118