A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies

Official Title: “Randomized, Double Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-036 in Patients With Seasonal Allergic Rhinitis”

The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone

Intervention(s) in this Clinical Trial

• Drug: Placebo nasal spray
  • Placebo
• Drug: 0.15% azelastine hydrochloride Nasal Spray
  • 0.15% azelastine hydrochloride 822 mcg

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo Nasal Spray
  • 0mg Placebo Nasal Spray
• Active Comparator: 0.15% azelastine hydrochloride nasal spray
  • 0.15% azelastine hydrochloride

Primary Measures

• Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days
  • Time Frame: baseline and 14 days
    Safety Issue?: No

Secondary Measures

• Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo
  • Time Frame: baseline and 14 days
    Safety Issue?: No
• Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days
  • Time Frame: baseline and 14-days
    Safety Issue?: No
• Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined)
  • Time Frame: baseline and 14-days
    Safety Issue?: No
• Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days
  • Time Frame: baseline and 14 Days
    Safety Issue?: No
• Change From Baseline on Direct Visual Nasal Exams at 14 Days
  • Time Frame: baseline and 14 days
    Safety Issue?: Yes

Inclusion Criteria:

• Male and female patients 12 years of age and older with a 2 year history of moderate to severe seasonal allergic rhinitis
• Must be in generally good health
• Must meet minimum symptom requirements, as specified in the protocol
• Must be willing and able to provide informed consent and to participate in all study procedures
• Positive skin test to a prevalent fall allergen

Exclusion Criteria:

• On focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study.
• Other nasal disease(s)likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
• Nasal Surgery or sinus surgery within the previous year
• Chronic sinusitis-more than 3 episodes a year
• Planned travel outside of the study area during the study period
• The use of any investigational drug within 30 days prior to screening. No investigational products are permitted for use during the conduct of the study.
• Presence of any hypersensitivity to drugs similar to azelastine and to either sorbital or sucralose (Splenda brand sweetener)
• Women who are pregnant or nursing
• Women of childbearing potential who are not abstinent or not practicing medically acceptable method of contraception
• Respiratory tract infection within 14 days prior to screening
• Respiratory tract infections requiring antibiotic treatment 14 days prior to screening
• Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not for more often tha twice a week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
• Significant pulmonary disease including COPD
• Clinically significant arrythmia or symptomatic cardiac conditions
• A known history of alcohol or drug abuse within the last 2 years
• Existence of any surgical or medical condition or physical laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial
• Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures.

Gender Eligibility for this Clinical Trial: Female

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/NCT00719862

Study ID Number: MP439

ClinicalTrials.gov Identifier: NCT00719862

Health Authority: United States: Food and Drug Administration