A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Meda Pharmaceuticals
• Treatments: Azelastine; Fluticasone; Xhance

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