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

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: Placebo (Drug); 0.15% azelastine hydrochloride (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Meda Pharmaceuticals

Official(s) and/or principal investigator(s):
Lewis M Fredane, MD, Study Director, Affiliation: Meda Pharmaceuticals

Overall contact:
Carrie L D'Andrea, MS, Phone: 732-564-2538

The purpose of this study is to determine if one allergy medication (0. 15% azelastine hydrochloride) is more effective than Placebo alone

Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 in Subjects With Seasonal Allergic Rhinitis

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

Primary outcome: Change from baseline in 12-hour reflective total nasal symptom score

Secondary outcome:

End of 24 hour dosing interval: A key secondary endpoint will be mean change from baseline in instantaneous TNSS for the entire 14-day study period compared to placebo to determine if the duration of efficacy lasts 24 hours.

Change from baseline in instantaneous TNSS for the entire 14-day study period compared to placebo

Change from baseline in 12-hour reflective individual TNSS for the entire 14-day study period compared to placebo

Daily scores - Daily change from baseline in 12-hour reflective and instantaneous TNSS compared to placebo for the 14-day study period

Change from baseline in 12-hour reflective TOSS and instantaneous TOSS for the entire 14-day study period compared to placebo

Change from baseline in the 12-hour reflective individual TOSS symptom scores for the entire 14-day study period compared to placebo

Change from baseline to visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) compared to placebo in subjects 18 years of age and older

Subject-reported adverse experiences (incidence, type, and severity of adverse events)

Focused Nasal Examination at each visit.

Vital signs assessments at each visit.

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Male and female subjects 12 years of age and older

2. Provide written informed consent/pediatric assent. If the subject 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 visit 1

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 visit 2, and can include the morning of visit 2) 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 visit 2, and can include the morning of visit 2)

5. Willing and able to comply with the study requirements

6. At least a 2-year history of SAR during Texas Mountain Cedar season

7. The presence of IgE-mediated hypersensitivity to Texas Mountain Cedar, confirmed by a positive response to 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.

8. 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.

9. Subjects 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 do not preclude participation).Dose reduction when a new bottle is used does not preclude participation.

10. Subjects 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 superficial and moderate nasal mucosal erosion, nasal mucosal ulceration, or nasal septum perforation (Grade 1b-4) at either screening visit or randomization visit will disqualify the subjects from the study.

2. Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or clinically significant 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 visit 1. 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 visit 1

11. Respiratory Tract Infections requiring antibiotic treatment 14 days prior to visit 1

12. Asthma (with the exception of 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

13. Significant pulmonary disease including COPD

14. Clinically significant arrhythmia or symptomatic cardiac conditions

15. A known history of alcohol or drug abuse within the last 2 years

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; that might significantly affect the subject's ability to complete this trial; or their safety in 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 MP439 or MP440.

19. Employees of the research center / private practice and their family are excluded

Carrie L D'Andrea, MS, Phone: 732-564-2538

Allergy and Asthma Associates, Austin, Texas 78731, United States; Recruiting

Allergy and Asthma Center of Austin, Austin, Texas 78759, United States; Recruiting

Allergy and Asthma Center, Waco, Texas 76712, United States; Recruiting

Allergy, Asthma Research Center, San Antonio, Texas 78258, United States; Recruiting

Central Texas Health Research, New Braunfels, Texas 78130, United States; Recruiting

Southwest Allergy and Asthma Center, P.A., San Antonio, Texas 78229, United States; Recruiting

Sylvana Research Associates, San Antonio, Texas 78229, United States; Recruiting

Starting date: December 2008
Ending date: March 2009
Last updated: January 14, 2009