Official Title: “Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Subjects 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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: Placebo
  • Placebo
• Drug: 0.15% Azelastine Hydrochloride
  • 0.15% Azelastine Hydrochloride 822 mcg

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo
• Active Comparator: 2
  • 0.15% Azelastine Hydrochloride

Primary Measures

• Change from baseline in 12-hour reflective total nasal symptom score
  • Time Frame: 14 days
    Safety Issue?: No

Secondary Measures

• Change from baseline in 12 hour instantaneous total nasal symptom score
  • Time Frame: 14-day
    Safety Issue?: No
• Change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
  • Time Frame: 14 Days
    Safety Issue?: No

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 Texas Mountain Cedar 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 per 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 this study
• Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
• Women who are pregnant or nursing
• Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
• Respiratory Tract Infections 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 more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
• Significant pulmonary disease including COPD
• Clinically significant arrhythmia 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 or 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: 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 Sponsor: Meda Pharmaceuticals

Overall Clinical Trial Officials and Contacts

Lewis M Fredane, MD Study Director Meda Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00660829

Study ID Number: MP440

ClinicalTrials.gov Identifier: NCT00660829

Health Authority: United States: Food and Drug Administration