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

Official Title: “Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis”

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

Intervention(s) in this Clinical Trial

• Drug: 0.15% azelastine hydrochloride
  • 1644 mcg (205.5 mcg/spray) 2 sprays per nostril twice a day/AM and PM
• Drug: Mometasone furoate
  • 200 mcg (50 mcg/spray) 2 sprays per nostril Once a day (AM)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 0.15% azelastine hydrochloride 1644 mcg
• Experimental: 2
  • Mometasone furoate 200 mcg

Primary Measures

• Change From Baseline on Direct Visual Nasal Exams to 12 Months
  • Time Frame: Change from baseline to 12 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Meda Pharmaceuticals Industry

Overall Clinical Trial Officials and Contacts

Lewis M. Fredane, MD Study Director Meda Pharmaceuticals  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00720382

Study ID Number: MP436

ClinicalTrials.gov Identifier: NCT00720382

Health Authority: United States: Food and Drug Administration