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

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

Study Type: Interventional

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

Study Primary Completion Date: October 2007

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Placebo
• Experimental: 2
  • 0.1% azelastine hydrochloride
• Experimental: 3
  • 0.15% azelastine hydrochloride

Primary Measures

• Change from baseline in 12-hour reflective total nasal symptom score for the entire 14-day study period compared to placebo
  • Time Frame: 14 days
    Safety Issue?: No

Secondary Measures

• Change from baseline in instantaneous total nasal symptom score for the entire 14-day study period compared to placebo
  • Time Frame: 14 Days
    Safety Issue?: No
• Change from baseline in 12-hour reflective individual symptom scores for the entire 14-day study period compared to placebo
  • Time Frame: 14 days
    Safety Issue?: No
• Onset of action (change from baseline in instantaneous total nasal symptom score compared to placebo over the 4-hour period following initial administration of study drugs)
  • Time Frame: 4 hours
    Safety Issue?: No
• Daily scores - Daily change from baseline in 12-hour reflective and instantaneous total nasal symptom score compared to placebo for the 14-day study period
  • Time Frame: 14 days
    Safety Issue?: No
• Change from baseline in the 12-hour reflective secondary symptom complex score for the entire 14-day study period compared to placebo
  • Time Frame: 14 days
    Safety Issue?: No
• Change from baseline in the 12-hour reflective secondary symptom complex score individual symptom scores for the entire 14-day study period compared to placebo
  • Time Frame: 14 days
    Safety Issue?: No
• Change from baseline to Day 14 in the rhinoconjunctivitis quality of life questionnaire (RQLQ) compared to placebo in patients 18 years of age and older
  • Time Frame: 14 days
    Safety Issue?: No
• Change from baseline on direct visual nasal exams
  • Time Frame: 14 days
    Safety Issue?: Yes

Inclusion Criteria:

• 1. Male and female patients 12 years of age and older
• 2. Provide written informed consent/pediatric assent. If the patient is a minor, a parent or legal guardian must give written informed consent
• 3. Screening Visit: Have a 12-hour reflective TNSS of at least 8 out of a possible 12 and a congestion score of 2 or 3 on Day -7
• 4. Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period. In addition, an AM or PM 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day
• 1)
• 5. Randomization Visit: An instantaneous TNSS of ≥ 8 before beginning the onset of action assessment on Day 1
• 6. Must have taken at least 10 doses of study medication during the lead-in period
• 7. Willing and able to comply with the study requirements
• 8. At least a 2-year history of SAR
• 9. The presence of IgE-mediated hypersensitivity to ragweed antigen or other local fall allergens, confirmed by a positive response to either skin prick within the last year.
• A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control for the skin prick test.
• 10. General good health and free of any disease or concomitant treatment that could interfere with the interpretation of the study results as determined by the investigator or the sponsor's medical officer. When in doubt, the investigator should confer with the sponsor's medical monitor or designee to determine eligibility for the study.
• 11. Patients receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit (adjustments to regimen following a brief period of missed injections does not preclude participation). Patients currently receiving sublingual immunotherapy are excluded. A 6-month washout period is required following the last dose of sublingual immunotherapy.

Exclusion Criteria:

• 1. 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 patient from the study.
• 2. Other nasal disease(s) likely such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
• 3. Nasal surgery or sinus surgery within the previous year.
• 4. Chronic sinusitis - more than 3 episodes per year
• 5. Planned travel outside of the study area during the study period
• 6. The use of any investigational drug within 30 days prior to Day -7. No investigational products are permitted for use during the conduct of this study
• 7. Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose (Splenda® brand sweetener)
• 8. Women who are pregnant or nursing
• 9. Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception
• 10. Respiratory Tract Infections within 14 days prior to Day -7
• 11. Respiratory Tract Infections requiring oral antibiotic within 14 days of Day -7
• 12. Asthma (with the exception of mild, intermittent asthma). Patients with mild, intermittent asthma who only require short-acting inhaled bronchodilators are eligible for enrollment.
• 13. Significant pulmonary disease including COPD
• 14. Clinically significant arrhythmia or with symptomatic cardiac conditions
• 15. A known history of alcohol or drug abuse
• 16. 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 or that might significantly affect the patient's ability to complete this trial.
• 17. Clinically relevant abnormal physical findings within 1 week of randomization which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures
• 18. Participation in MedPointe Protocols MP433, MP434, MP435, or MP436.
• 19. Employees of the research center or private practice and their family members are excluded
• 20. Patients who received prohibited medications within specified timepoints in the 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 Sponsor: Meda Pharmaceuticals

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00720278

Study ID Number: MP438

ClinicalTrials.gov Identifier: NCT00720278

Health Authority: United States: Food and Drug Administration