A Study to Evaluate the Safety & 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 one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone

Key facts

Study ID

NCT00719862

Run by

Meda Pharmaceuticals

People needed

481

Starts

2007-08-01

Expected to finish

2007-11-01

Last updated by the study team

2010-02-02

Who can join

Age: 12 and older. Sex: female. 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 willing and able to provide informed consent and to participate in all study procedures
• Positive skin test to a prevalent fall allergen

You may not qualify if…

• On focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study.
• Other nasal disease(s)likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
• Nasal Surgery or sinus surgery within the previous year
• Chronic sinusitis-more than 3 episodes a year
• Planned travel outside of the study area during the study period
• The use of any investigational drug within 30 days prior to screening. No investigational products are permitted for use during the conduct of the study.
• Presence of any hypersensitivity to drugs similar to azelastine and to either sorbital or sucralose (Splenda brand sweetener)
• Women who are pregnant or nursing
• Women of childbearing potential who are not abstinent or not practicing medically acceptable method of contraception
• Respiratory tract infection within 14 days prior to screening
• Respiratory tract infections requiring antibiotic treatment 14 days prior to screening
• Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not for more often tha twice a week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
• Significant pulmonary disease including COPD
• Clinically significant arrythmia or symptomatic cardiac conditions
• A known history of alcohol or drug abuse within the last 2 years
• Existence of any surgical or medical condition or physical laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial
• Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures.

Where it is running

• Allergy and Asthma Specialist Medical Group — Huntington Beach, California, United States
• Allergy, Asthma and Respiratory Care medical Center — Long Beach, California, United States
• Allergy and Asthma Medical Group and Research Center — San Diego, California, United States
• Allergy & Asthma Associates of Santa Clara Valley Research Cntr — San Jose, California, United States
• Bensch Research Associates — Stockton, California, United States
• Colorado Allergy and Asthma centers, PC — Lakewood, Colorado, United States
• University of South Florida — Tampa, Florida, United States
• Aeroallergy Research Laboratories of Savannah — Savannah, Georgia, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Atlanta Allergy and Asthma Clinic — Woodstock, Georgia, United States
• Sneeze, Wheeze and Itch Associates — Normal, Illinois, United States
• Kansas City Allergy and Asthma — Overland Park, Kansas, United States
• RX R+D — Metairie, Louisiana, United States
• Chesapeake Clinical Research, Inc — Baltimore, Maryland, United States
• Institute for Asthma and Allergy PC — Wheaton, Maryland, United States
• Clinical Research Institute — Plymouth, Minnesota, United States
• The Clinical Research Center — St Louis, Missouri, United States
• Midwest Allergy and Asthma Clinic — Omaha, Nebraska, United States
• The Asthma and Allergy Center — Papillion, Nebraska, United States
• Las Vegas Physicians Research Group — Henderson, Nevada, United States
• Allergy and Asthma Research NJ inc — Mount Laurel, New Jersey, United States
• Allergy Consultants PA — Verona, New Jersey, United States
• AAIR Research Center — Rochester, New York, United States
• OIAA Clinical Research, LLC — Edmond, Oklahoma, United States
• Asthma and Allergy Research Associates — Chester, Pennsylvania, United States

Full record on ClinicalTrials.gov

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