A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Registration Number
- NCT00651118
- Lead Sponsor
- Meda Pharmaceuticals
- Brief Summary
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)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 832
- 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
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - azelastine Hcl azelastine Hcl - azelastineHcl/fluticasone propionate azelastineHcl / fluticasone propionate - fluticasone propionate fluticasone propionate -
- Primary Outcome Measures
Name Time Method Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS) days 1 to 14 change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.
The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result.
- Secondary Outcome Measures
Name Time Method Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) day 1 to day 14 change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period.
The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result.Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days day 1 to day 14 adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14.
The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result.
Trial Locations
- Locations (39)
Jane Lee, MD, PA Research Center
🇺🇸Dallas, Texas, United States
Allergy Research Foundation
🇺🇸Los Angeles, California, United States
Asthma, Inc.
🇺🇸Seattle, Washington, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Southern California Research
🇺🇸Mission Viejo, California, United States
Clinical Research Center
🇺🇸Encinitas, California, United States
Allergy, Asthma and Immunology Associates
🇺🇸Lincoln, Nebraska, United States
Central Texas Health Research
🇺🇸New Braunfels, Texas, United States
Allergy and Asthma Medical Group and Research Center
🇺🇸San Diego, California, United States
Allergy and Asthma Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Storms Clinical Research Institute
🇺🇸Colorado Springs, Colorado, United States
Bensch Research Associates
🇺🇸Stockton, California, United States
Aeroallergy Research Laboratories of Savannah
🇺🇸Savannah, Georgia, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Sneeze, Wheeze and Itch Associates
🇺🇸Normal, Illinois, United States
Northeast Medical Research Associates
🇺🇸North Dartmouth, Massachusetts, United States
Kansas City Allergy and Asthma
🇺🇸Overland Park, Kansas, United States
Clinical Research Institute
🇺🇸Plymouth, Minnesota, United States
The Clinical Research Center
🇺🇸St. Louis, Missouri, United States
Research Asthma, Sinus and Allergy Centers
🇺🇸Warren, New Jersey, United States
The Asthma and Allergy Center
🇺🇸Papillion, Nebraska, United States
Atlantic Research Center
🇺🇸Ocean, New Jersey, United States
Island Medical Research
🇺🇸Rockville Center, New York, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
AAIR Research Center
🇺🇸Rochester, New York, United States
Allergy Asthma and Dermatology Research
🇺🇸Lake Oswego, Oregon, United States
Allergy and Consultants of NJ/PA
🇺🇸Collegeville, Pennsylvania, United States
Bernstein Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Allergy Clinic of Tulsa
🇺🇸Tulsa, Oklahoma, United States
Allergy and Clinical Immunology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
Asthma and Allergy Research Associate
🇺🇸Upland, Pennsylvania, United States
National Allergy, Asthma and Urticaria of Charleston
🇺🇸Charleston, South Carolina, United States
East Tennesse Center for Clinical Research
🇺🇸Knoxville, Tennessee, United States
Allergy and Asthma Associates
🇺🇸Austin, Texas, United States
Allergy and Asthma Center of Austin
🇺🇸Austin, Texas, United States
AARA Research Center
🇺🇸Dallas, Texas, United States
Sylvana Research Associates
🇺🇸San Antonio, Texas, United States
Intermountain Clinical Research
🇺🇸Draper, Utah, United States
Colorado Allergy and Asthma Centers
🇺🇸Lakewood, Colorado, United States