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A Study to Evaluate the Safety and Tolerability of a Nasal Spray to Treat Perennial Allergic Rhinitis

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); Mometasone furoate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Meda Pharmaceuticals

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

Summary

The purpose of this study is to determine if one allergy treatment (0. 15% azelastine hydrochloride) is as safe as mometasone furoate (nasonex) alone.

Clinical Details

Official title: Active Controlled Trial of the Safety and Tolerability of MP 03-036 (Astepro 0.15%) in Patients With Perennial Allergic Rhinitis

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline on Direct Visual Nasal Exams to 12 Months

Eligibility

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

Criteria:

Inclusion Criteria:

- Male and female patients 12 years and older with a compatible history greater than or

equal to 1 year of rhinitis due to perennial allergies.

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

procedures

- Must be in generally good health

- Positive skin test to a prevalent perennial allergen

Exclusion Criteria:

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

nasal septal perforation

- Use of any investigational drug within 30 days of the first visit

- Any nasal surgery or sinus surgery within the previous year

- Presence of any hypersensitivity to drugs similar to azelastine or mometasone furoate

and to either sorbital or sucralose

- Women who are pregnant or nursing

- Women who are not using an acceptable method of birth control

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

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

- Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered

after consultation with investigator.

- Patients with Arrythmia

- Patients with know history of alcohol and drug abuse

- Existence of any surgical or medical condition, which in the opinion of the

investigator or sponsor, might significantly alter the evaluation of the study.

- Use of medications that could affect the study results

Locations and Contacts

Center of Research Excellence, LLC, Oxford, Alabama 36203, United States

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

Allergy and Asthma Specialist Medical Group, Huntington Beach, California 92647, 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 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 & Asthma Associates of Santa Clara Valley Research Cntr, San Jose, California 95117, United States

Bensch Research Associates, Stockton, California 95207, United States

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

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

Allergy and Asthma Care of Florida, Ocala, Florida 34471, United States

Allergy and Asthma DTC, Tallahassee, Florida 32308, United States

Georgia Pollens Clinical Research Centers Inc, Albany, Georgia 31707, United States

Aeroallergy Research Laboratories of Savannah, Savannah, Georgia 31406, United States

Clinical Research Atlanta, Stockbridge, Georgia 30281, United States

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

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

RX R+D, Metairie, Louisiana 70001, 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

The Asthma and Allergy Center, Papillion, Nebraska 68046, 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

Medical Research Associates of CNY, PLLC, North Syracuse, New York 13212, 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

Oklahoma Institute of Allergy and Asthma Clinical, Edmond, Oklahoma 73003, 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 Asthma Specialist PC, Blue Bell, Pennsylvania 19422, United States

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

Allergy and Clinical Immunology Associates, Pittsburgh, Pennsylvania 15241, 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

Western Sky Medical Research, El Paso, Texas 79902, United States

SWAAA Research Center, Houston, Texas 77074, United States

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

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

Live Oak Allergy and Asthma Clinic, San Antonio, Texas 78233, United States

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

Allergy Asthma Research Institute, Waco, Texas 76712, United States

VA Adult and Pediatric Allergy and Asthma, Richmond, Virginia 23229, United States

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

Advanced Healthcare, Milwaukee, Wisconsin 53209, United States

Additional Information

Starting date: March 2007
Last updated: May 4, 2015

Page last updated: August 23, 2015

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