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); azelastine Hcl (Drug); azelastineHcl / fluticasone propionate (Drug); fluticasone propionate (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

The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)

Official title: Randomized, Double-Blind Trial of MP29-02 Nasal Spray Compared to Placebo, Azelastine Hydrochloride Nasal Spray, and Fluticasone Propionate Nasal Spray in the Treatment of Patients With Seasonal 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 (rTNSS)

Secondary outcome:

Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)

Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days

Detailed description: This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin

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; and the symptom of postnasal drip, 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.

Criteria:

Inclusion Criteria:

- Male and female patients 12 years of age and older with a 2 year history of

moderate to severe seasonal allergic rhinitis

- Must be in generally good health

- Must meet minimum symptom requirements, as specified in the protocol

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

procedures

- Positive skin test to a prevalent spring allergen

Exclusion criteria:

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

septal perforation

- Nasal disease likely to affect the deposition of the medication or evaluation, such

as sinus infection, nasal polyps or severe deviated septum

- Nasal or sinus surgery within the previous 6 months

- Chronic sinus infection (more than 3 per year)

- Planned travel outside the study area during the study period

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

- Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or

fluticasone propionate nasal spray (Flonase)

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

- Women who are pregnant or nursing

- Upper respiratory tract infection such as common cold, flu, sinus infection within 2

weeks of first study visit

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

after consultation with the investigator

- Irregular heartbeat or other symptomatic heart conditions

- History of alcohol or drug abuse

- History of glaucoma

- Use of medications that could affect the study results

Allergy, Asthma and Immunology Associates, Scottsdale, Arizona 85251, United States

Clinical Research Center, Encinitas, California 92024, United States

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

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

Peninsula Research Associates, Rolling Hills Estates, California 90274, United States

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

Bensch Research Associates, Stockton, California 95207, United States

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

Storms Clinical Research Institute, Colorado Springs, Colorado 80907, United States

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

Colorado Allergy and Asthma Centers, Lakewood, Colorado 80401, United States

Clinical Research Atlanta, Atlanta, Georgia 30342, 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

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

Allergy, Asthma and Immunology Associates, Lincoln, Nebraska 68505, United States

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

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

Research Asthma, Sinus and Allergy Centers, Warren, New Jersey 07059, United States

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

Island Medical Research, Rockville Center, New York 11570, United States

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

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

Allergy Clinic of Tulsa, Tulsa, Oklahoma 74133, United States

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

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

Jane Lee, MD, PA Research Center, Dallas, Texas 75246, United States

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

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

Intermountain Clinical Research, Draper, Utah 84020, United States

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

Starting date: March 2008
Last updated: August 27, 2012