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

Information source: Meda Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Perennial Allergic Rhinitis

Intervention: 0.15% azelastine hydrochloride (Drug); 0.1% azelastine hydrochloride (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Meda Pharmaceuticals

Summary

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

Clinical Details

Official title: Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of MP03-36 and MP03-33 in Patients With Perennial Allergic Rhinitis

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

Primary outcome: Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days.

Secondary outcome:

Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days

Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days

Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days

Change From Baseline on Direct Visual Nasal Exams and 28 Days

Eligibility

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

Criteria:

Inclusion Criteria:

- Male and female patients 12 years of age and older

- Must be in generally good health

- Must meet minimum symptom requirements, as specified in protocol

- Must be willing and able to provide informed consent and participate in all study

procedures

- 2-year history of PAR

- Positive skin test to cockroach, dust mite, mold or cat/dog dander

Exclusion Criteria:

- On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or

nasal septal perforation at the screening or randomization visit

- Nasal diseases likely to affect deposition of intranasal medication, such as

sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities

- Nasal surgery or sinus surgery within the previous year

- The use of any investigational drug within 30 days

- Presence of any hypersensitivity to drugs similar to azelastine and to either

sorbitol or sucralose

- Women who are pregnant or nursing

- Women of child-bearing potential who are not abstinent and not practicing a medically

acceptable method of contraception

- Respiratory tract infection within 2 weeks of screening

- Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of

screening

- Patients with asthma with the exception of mild, intermittent

- Significant pulmonary disease including COPD

- Patients with arrhythmia

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

- Clinically relevant abnormal physical findings within one week of randomization

- Overnight abscences from home for more than 3 nights

- Employees of the research center or private practice and family members are excluded

- Patients who received prohibited medications within specified timepoints in protocol.

Locations and Contacts

Allergy and Asthma Specialist Medical Group, Huntington Beach, California 92647, United States

Allergy, Asthma and Respiratory Care medical Center, 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 and Asthma Medical Group and Research Center, San Diego, California 92123, United States

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

Allergy and Asthma Clinical Research, Inc., Walnut Creek, California 94598, United States

Asthma and Allergy Associates, Colorado Springs, Colorado 80907, United States

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

Atlanta Allergy and Asthma Clinic, Woodstock, Georgia 30188, United States

Sneeze, Wheeze and Itch Associates, Normal, Illinois 61761, United States

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

Institute for Asthma and Allergy PC, Wheaton, Maryland 20902, United States

Northeast Medical Research Associates, North Dartmouth, Massachusetts 02747, United States

Clinical Research Institute, Minneapolis, Minnesota 55402, United States

Clinical Research Institute, Plymouth, Minnesota 55441, United States

The Clinical Research Center, St. Louis, Missouri 63141, United States

Las Vegas Physicians Research Group, Henderson, Nevada 89052, United States

Allergy and Asthma Research NJ inc, Mount Laurel, New Jersey 08054, United States

Atlantic Research Center, Ocean, New Jersey 07712, United States

Dr. Perin, Teaneck, New Jersey 07666, United States

AAIR Research Center, Rochester, New York 14618, United States

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

Wake Research Associates, LLC, Raleigh, North Carolina 27612, United States

Bernstein Clinical Research Center, Cincinnati, Ohio 45231, United States

New Horizon's Clinical Research, Cincinnati, Ohio 45252, United States

Allergy, Asthma and Clinical Research Center, Oklahoma City, Oklahoma 73120, United States

Allergy Asthma and Dermatology Research, Lake Oswego, Oregon 97035, United States

Clinical Research Institute of Southern Oregon, PC, Medford, Oregon 97504, United States

Allergy and Consultants of NJ/PA, Collegeville, Pennsylvania 19426, United States

Asthma and Allergy Research Associate, Upland, Pennsylvania 19013, United States

Asthma, Nasal Disease & Allergy Research Center of New England, Providence, Rhode Island 02906, United States

National Allergy, Asthma and Urticaria of Charleston, Charleston, South Carolina 29407, United States

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

AARA Research Center, Dallas, Texas 75231, United States

Pharmaceutical Research & Consulting Inc, Dallas, Texas 75231, United States

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

Biogenics Research Institute, San Antonio, Texas 78229, United States

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

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

Virginia Adult & Pediactric Allergy & Asthma, PC, Richmond, Virginia 23229, United States

Asthma, Inc., Seattle, Washington 98105, United States

Advanced Healthcare, SC, Milwaukee, Wisconsin 53209, United States

Additional Information

Starting date: January 2007
Last updated: June 6, 2011

Page last updated: August 23, 2015

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