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

Completed · Phase 3 · Has a placebo group

Conditions studied: Perennial Allergic Rhinitis

In brief

The purpose of this study is to determine if two allergy medications are more effective than placebo.

Key facts

Study ID

NCT00712920

Run by

Meda Pharmaceuticals

People needed

581

Starts

2007-01-01

Last updated by the study team

2011-06-08

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
• Must be in generally good health
• Must meet minimum symptom requirements, as specified in protocol
• Must be willing and able to provide informed consent and participate in all study procedures
• 2-year history of PAR
• Positive skin test to cockroach, dust mite, mold or cat/dog dander

You may not qualify if…

• On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
• Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
• Nasal surgery or sinus surgery within the previous year
• The use of any investigational drug within 30 days
• Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
• Women who are pregnant or nursing
• Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
• Respiratory tract infection within 2 weeks of screening
• Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
• Patients with asthma with the exception of mild, intermittent
• Significant pulmonary disease including COPD
• Patients with arrhythmia
• Patients with a known history of alcohol or drug abuse
• Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
• Clinically relevant abnormal physical findings within one week of randomization
• Overnight abscences from home for more than 3 nights
• Employees of the research center or private practice and family members are excluded
• Patients who received prohibited medications within specified timepoints in protocol.

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 Research Foundation — Los Angeles, California, United States
• Southern California Research — Mission Viejo, California, United States
• Allergy Associates Medical Group Inc — San Diego, California, United States
• Allergy and Asthma Medical Group and Research Center — San Diego, California, United States
• Allergy and Asthma Clinical Research, Inc. — Walnut Creek, California, United States
• Asthma and Allergy Associates — Colorado Springs, Colorado, United States
• The William Storms Allergy Clinic — Colorodo Springs, Colorado, 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
• Institute for Asthma and Allergy PC — Wheaton, Maryland, 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
• Las Vegas Physicians Research Group — Henderson, Nevada, United States
• Allergy and Asthma Research NJ inc — Mount Laurel, New Jersey, United States
• Atlantic Research Center — Ocean City, New Jersey, United States
• Dr. Perin — Teaneck, New Jersey, United States
• AAIR Research Center — Rochester, New York, United States
• North Carolina Clinical Research — Raleigh, North Carolina, United States
• Wake Research Associates, LLC — Raleigh, North Carolina, United States
• Bernstein Clinical Research Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.