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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Meda Pharmaceuticals
• Treatments: Azelastine

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.