A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if one allergy treatment (0.15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.

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

Details

• Lead Sponsor: Meda Pharmaceuticals
• Treatments: Azelastine; Mometasone Furoate

Criteria

Inclusion Criteria:

• Male and female patients 12 years and older with a compatible history greater than or equal to 1 year of rhinitis due to perennial allergies.

• Must be willing and able to provide informed consent and to participate in all study procedures

• Must be in generally good health

• Positive skin test to a prevalent perennial allergen

Exclusion Criteria:

• On nasal examination, the presence of nasal mucosal erosion, nasal ulceration or nasal septal perforation

• Use of any investigational drug within 30 days of the first visit

• Any nasal surgery or sinus surgery within the previous year

• Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate and to either sorbital or sucralose

• Women who are pregnant or nursing

• Women who are not using an acceptable method of birth control

• Nasal Diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa or clinically significant nasal polyposis or nasal structural abnormalities.

• Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered after consultation with investigator.

• Patients with Arrythmia

• Patients with know history of alcohol and drug abuse

• Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor, might significantly alter the evaluation of the study.

• Use of medications that could affect the study results