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

Condition(s) targeted: Seasonal Allergic Rhinitis

Intervention: azelastine hydrochloride 0.15% Nasal Spray (Drug); azelastine hydrochloride 0.15% and Placebo (Drug); Azelastine 0.1%, Nasal Spray (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Meda Pharmaceuticals

The Purpose of this study is to evaluate the safety and efficacy of MP03-36 (0. 15% azelastine hydrochloride)at dosages of 2 sprays per nostril once daily and 2 sprays per nostril twice daily in patients with seasonal allergic rhinitis.

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in 12-hour reflective total nasal symptoms score(TNSS) for the entire 14-day study period compared to placebo

Secondary outcome:

Change from baseline in instantaneous total nasal symptoms score (TNSS) for the entire 14-day study period compared to placebo

Change from baseline to Day 14 in Roland Quality of Life Questionnaire (RQLQ )compared to placebo

Change From Baseline on Direct Visual Nasal Exams

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

Criteria:

Inclusion Criteria:

- Male and female patients 12 years of age and older

- Provide written informed consent/pediatric assent. If the patient is a minor, a

parent or legal guardian must give written informed consent

- Screening Visit: Have a 12-hour reflective total nasal symptoms score ( TNSS) of at

least 8 out of a possible 12 and a congestion score of 2 or 3 on Day - 7

- Randomization Visit: Have a 12-hour reflective total nasal symptoms score (TNSS) (AM

or PM) of at least 8 on 3 separate 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 nasal congestion score of 2 or 3 must have been recorded on 3 separate assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1).

- Must have taken at least 10 doses of study medication during the lead-in period

- Randomization Visit: An instantaneous (TNSS) of ≥ 8 before beginning the onset of

action assessment on Day 1

- Willing and able to comply with the study requirements

- At least a 2-year history of seasonal allergic rhinitis (SAR) during the fall pollen

allergy season

- The presence of IgE-mediated hypersensitivity to local fall pollen confirmed by a

positive response to either skin prick or intradermal testing within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the control for the skin prick test or at least 7 mm larger than the control for the intradermal test.

- 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

- 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 who are on maintenance doses of sublingual immunotherapy may be considered for the trial on a case-by-case basis after discussion with the sponsor's medical monitor or designee. Exclusion Criteria:

- 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

- 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 and not practicing a medically

acceptable method of contraception

- Respiratory tract infections within two weeks prior to Day -7

- Respiratory Infections requiring oral antibiotic treatment two weeks prior to Day -7

- Other nasal disease(s) likely to affect deposition of intranasal medication, such as

sinusitis, rhinitis medicamentosa or clinically significant polyposis or nasal structural abnormalities

- Patients with asthma (with the exception of mild, intermittent asthma)

- Patients with significant pulmonary disease

- 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, might significantly alter the absorption, distribution, metabolism, or excretion of study drug

- 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

- Planned travel outside the study area during the study period

- Family members and employees should be excluded

- Patients who received prohibited medications within specified timepoints in the

protocol.

AABI Associates Medical Group, Fountain Valley, California 92708, United States

West Coast Clinical Trials, Long Beach, California 90806, United States

Allergy Research Foundation, Los Angeles, California 90025, United States

Southern California Research, Mission Viejo, California 92691, United States

Allergy Medical Group, Roseville, California 95678, United States

Allergy Associates Medical Group, San Diego, California 92120, United States

Allergy and Asthma Associates of CA, San Jose, California 95117, United States

The William Storms Allergy Clinic, Colorado Springs, Colorado 80907, United States

Colorado Allergy and Asthma Centers, PC, Denver, Colorado 80230, United States

Coastal Allergy and Asthma P.C., Savannah, Georgia 31406, United States

Kansas City Allergy and Asthma, Overland Park, Kansas 66210, United States

Institute for Asthma and Allergy, P.C., Wheaton, Maryland 20902, United States

Northeast Medical Research Associates, Inc., N. Dartmouth, Massachusetts 02747, United States

Clinical Research Institute, Minneapolis, Minnesota 55402, United States

The Asthma and Allergy Center, PC, Papillion, Nebraska 68046, United States

Atlantic Allergy, Asthma & Immunology, Ocean, New Jersey 07712, United States

Princeton Center for Clinical Research, Skillman, New Jersey 08558, United States

Allergy and Asthma Institue of Rochester, Rochester, New York 14618, United States

North Carolina Clinical Research, Raleigh, North Carolina 27607, United States

Clinical Research Center, Cincinnati, Ohio 45231, United States

Oklahoma Institute of Allergy and Asthma, Edmond, Oklahoma 73003, United States

Allergy and Asthma Consultants of NJ-PA, P.C, Collegeville, Pennsylvania 19426, United States

Valley Clinical Research Center, Easton, Pennsylvania 18045, United States

Allergy and Clinical Immunology Associates, Pittsburgh, Pennsylvania 15241, United States

Allergy Asthma Associates Research Dept., Austin, Texas 78731, United States

Research Across America, Dallas,, Texas 75234, United States

AARA Research Center, Dallas, Texas 75231, United States

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

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

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

Starting date: August 2006
Last updated: October 5, 2011