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

Completed · Phase 3 · Has a placebo group

Conditions studied: Seasonal Allergic Rhinitis

In brief

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)

Key facts

Study ID

NCT00651118

Run by

Meda Pharmaceuticals

People needed

832

Starts

2008-03-01

Expected to finish

2008-07-01

Last updated by the study team

2012-09-26

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Allergy, Asthma and Immunology Associates — Scottsdale, Arizona, United States
• Clinical Research Center — Encinitas, California, United States
• Allergy Research Foundation — Los Angeles, California, United States
• Southern California Research — Mission Viejo, California, United States
• Peninsula Research Associates — Rolling Hills Estates, California, United States
• Allergy and Asthma Medical Group and Research Center — San Diego, California, United States
• Bensch Research Associates — Stockton, California, United States
• Allergy and Asthma Clinical Research, Inc. — Walnut Creek, California, United States
• Storms Clinical Research Institute — Colorado Springs, Colorado, United States
• Colorado Allergy and Asthma Centers — Denver, Colorado, United States
• Colorado Allergy and Asthma Centers — Lakewood, Colorado, United States
• Clinical Research Atlanta — Atlanta, Georgia, United States
• Aeroallergy Research Laboratories of Savannah — Savannah, Georgia, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Sneeze, Wheeze and Itch Associates — Normal, Illinois, United States
• Kansas City Allergy and Asthma — Overland Park, Kansas, United States
• Northeast Medical Research Associates — North Dartmouth, Massachusetts, United States
• Clinical Research Institute — Minneapolis, Minnesota, United States
• Clinical Research Institute — Plymouth, Minnesota, United States
• The Clinical Research Center — St Louis, Missouri, United States
• Allergy, Asthma and Immunology Associates — Lincoln, Nebraska, United States
• The Asthma and Allergy Center — Papillion, Nebraska, United States
• Atlantic Research Center — Ocean City, New Jersey, United States
• Research Asthma, Sinus and Allergy Centers — Warren Township, New Jersey, United States
• AAIR Research Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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