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

Official Title: “Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 in Patients With Perennial Allergic Rhinitis”

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

Intervention(s) in this Clinical Trial

• Drug: 0.15% azelastine hydrochloride
  • 0.15% azelastine hydrochloride 1644 mcg
• Drug: 0.1% azelastine hydrochloride
  • 0.1% azelastine hydrochloride 1096 mcg
• Drug: Placebo
  • Placebo

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo
• Experimental: 2
  • 0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks
• Experimental: 3
  • 0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks

Primary Measures

• Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.
  • Time Frame: baseline and 28 days
    Safety Issue?: No

Secondary Measures

• Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days
  • Time Frame: baseline and 28 days
    Safety Issue?: No
• Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days
  • Time Frame: baseline and 28 days
    Safety Issue?: No
• Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days
  • Time Frame: baseline and 28 Days
    Safety Issue?: No
• Change From Baseline on Direct Visual Nasal Exams and 28 Days
  • Time Frame: baseline and 28 days
    Safety Issue?: Yes

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.

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

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00712920

Study ID Number: MP434

ClinicalTrials.gov Identifier: NCT00712920

Health Authority: United States: Food and Drug Administration