The purpose of this study is to determine if the combination of two allergy medications
(formulated azelastine/fluticasone product)is more effective than placebo or either
component medication alone (azelastine or fluticasone).
with a 7-day, single-blind, placebo lead-in period (Day - 7 to Day 1). Subjects will be
instructed to take placebo lead-in medication twice daily (1 spray per nostril),
approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity
requirements and continue to meet all of the study inclusion/exclusion criteria will be
randomized in a 1: 1:1: 1 ratio to receive 1 spray per nostril twice daily of MP29-02,
azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.
Efficacy will be assessed by the change from baseline in the subject-reported 12-hour
reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the
instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and
nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms
of itchy eyes, watery eyes and eye redness; the symptom of postnasal drip will be
reflectively, twice daily (AM and PM) in a diary prior to the dose of study medication.
Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate
symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be
24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include
reflective individual nasal and ocular symptom scores, as well as change from Baseline to
Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14.
Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the
2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at
time of early termination) for an end-of-study evaluation. Safety and tolerability
assessments will be made on Days 7 and 14. Tolerability will be evaluated by
subject-reported adverse events (AEs), nasal examinations, and vital signs assessments
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Allergy, Asthma and Immunology Associates, Scottsdale, Arizona 85251, United States
Clinical Research Center, Encinitas, California 92024, United States
AABI Associates Medical Group, Fountain Valley, California 92708, United States
Allergy & Asthma Care Center of So. Cal, Long Beach, California 90808, 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
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
Storms Clinical Research Institute, Colorado Springs, Colorado 80907, United States
Colorado Allergy and Asthma Centers, Denver, Colorado 80230, United States
Clinical Research Atlanta, Atlanta, Georgia 30342, United States
Sneeze, Wheeze and Itch Associates, Normal, Illinois 61761, United States
Kansas City Allergy and Asthma, Overland Park, Kansas 66210, United States
Family Allergy and Asthma Reserach, Louisville, Kentucky 40215, United States
Northeast Medical Research Associates, North Dartmouth, Massachusetts 02747, United States
Clinical Reseacrh Institute, Minneapolis, Minnesota 55402, United States
The Clinical Research Center, St. Louis, Missouri 63141, United States
The Asthma and Allergy Center, Papillion, Nebraska 68046, United States
Atlantic Research Center, Ocean, New Jersey 07712, United States
Princeton Center for Clinical Research, Skillman, New Jersey 08558, United States
Research Asthma, Sinus and Allergy Centers, Warren, New Jersey 07059, United States
North Carolina Clinical Research, Raleigh, North Carolina 27607, United States
Bernstein Clinical Research Center, Cincinnati, Ohio 45231, United States
Allergy, Asthma and Clinical Research Center, Oklahoma City, Oklahoma 73120, 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
Allergy and Clinical Immunology Associates, Pittsburgh, Pennsylvania 15241, United States
National Allergy, Asthma and Urticaria of Charleston, Charleston, South Carolina 29407, United States
East Tennesse Center for Clinical Research, Knoxville, Tennessee 37909, United States
Allergy and Asthma Associates, Austin, Texas 78731, United States
Allergy and Asthma Center of Austin, Austin, Texas 78759, 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
Central Texas Health Research, New Braunfels, Texas 78130, United States
Allergy, Asthma Research Center, San Antonio, Texas 78258, United States
Diagnostic Research Group, San Antonio, Texas 78229, United States
Sylvana Research Associates, San Antonio, Texas 78229, United States
Allergy and Asthma Center, Waco, Texas 76712, United States
Allergy Asthma Research Institute, Waco, Texas 76712, United States
Intermountain Clinical Research, Draper, Utah 84020, United States
Asthma, Inc., Seattle, Washington 98105, United States