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)
Inclusion Criteria:
- Male and female patients 12 years of age and older with a 2 year history of moderate
to severe sasonal 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
Allergy, Asthma and Immunology Associates, Scottsdale, Arizona 85251, United States
Bensch Research Associates, Stockton, California 95207, United States
Southern California Research, Mission Viejo, California 92691, United States
Allergy Research Foundation, Los Angeles, California 90025, United States
Allergy and Asthma Clinical Research, Inc., Walnut Creek, California 94598, United States
Allergy and Asthma Medical Group and Research Center, San Diego, California 92123, United States
Clinical Research Center, Encinitas, California 92024, United States
Peninsula Research Associates, Rolling Hills Estates, California 90274, United States
Colorado Allergy and Asthma Centers, Lakewood, Colorado 80401, United States
Colorado Allergy and Asthma Centers, Denver, Colorado 80230, United States
Storms Clinical Research Institute, Colorado Springs, Colorado 80907, United States
Aeroallergy Research Laboratories of Savannah, Savannah, Georgia 31406, United States
Clinical Research Atlanta, Atlanta, Georgia 30342, United States
Clinical Research Atlanta, Stockbridge, Georgia 30281, United States
Sneeze, Wheeze and Itch Associates, Normal, Illinois 61761, United States
Kansas City Allergy and Asthma, Overland Park, Kansas 66210, United States
Northeast Medical Research Associates, North Dartmouth, Massachusetts 02747, United States
Clinical Research Institute, Plymouth, Minnesota 55441, United States
Clinical Research Institute, Minneapolis, Minnesota 55402, United States
The Clinical Research Center, St. Louis, Missouri 63141, United States
The Asthma and Allergy Center, Papillion, Nebraska 68046, United States
Allergy, Asthma and Immunology Associates, Lincoln, Nebraska 68505, United States
Research Asthma, Sinus and Allergy Centers, Warren, New Jersey 07059, United States
Atlantic Research Center, Ocean, New Jersey 07712, United States
AAIR Research Center, Rochester, New York 14618, United States
Island Medical Research, Rockville Center, New York 11570, United States
North Carolina Clinical Research, Raleigh, North Carolina 27607, United States
Bernstein Clinical Research Center, Cincinnati, Ohio 45231, United States
Allergy Clinic of Tulsa, Tulsa, Oklahoma 74133, United States
Allergy Asthma and Dermatology Research, Lake Oswego, Oregon 97035, United States
Allergy and Clinical Immunology Associates, Pittsburgh, Pennsylvania 15241, United States
Asthma and Allergy Research Associate, Upland, Pennsylvania 19013, United States
Allergy and Consultants of NJ/PA, Collegeville, Pennsylvania 19426, United States
National Allergy, Asthma and Urticaria of Charleston, Charleston, South Carolina 29407, United States
East Tennesse Center for Clinical Research, Knoxville, Tennessee 37909, United States
Central Texas Health Research, New Braunfels, Texas 78130, United States
Allergy and Asthma Center of Austin, Austin, Texas 78759, United States
Jane Lee, MD, PA Research Center, Dallas, Texas 75246, United States
AARA Research Center, Dallas, Texas 75231, United States
Sylvana Research Associates, San Antonio, Texas 78229, United States
Allergy and Asthma Associates, Austin, Texas 78731, United States
Intermountain Clinical Research, Draper, Utah 84020, United States
Asthma, Inc., Seattle, Washington 98105, United States
