A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
NCT ID: NCT00651118
Last Updated: 2012-09-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
832 participants
INTERVENTIONAL
2008-03-31
2008-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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fluticasone propionate
fluticasone propionate
fluticasone propionate 200 mcg
azelastineHcl/fluticasone propionate
azelastineHcl / fluticasone propionate
azelastine Hcl 548 mcg / fluticasone propionate 200 mcg
Placebo
Placebo
placebo
azelastine Hcl
azelastine Hcl
azelastine Hcl 548 mcg
Interventions
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Placebo
placebo
azelastine Hcl
azelastine Hcl 548 mcg
azelastineHcl / fluticasone propionate
azelastine Hcl 548 mcg / fluticasone propionate 200 mcg
fluticasone propionate
fluticasone propionate 200 mcg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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Meda Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Lewis M. Fredane, MD
Role: STUDY_DIRECTOR
Meda Pharmaceuticals
Locations
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Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, United States
Clinical Research Center
Encinitas, California, United States
Allergy Research Foundation
Los Angeles, California, United States
Southern California Research
Mission Viejo, California, United States
Peninsula Research Associates
Rolling Hills Estates, California, United States
Allergy and Asthma Medical Group and Research Center
San Diego, California, United States
Bensch Research Associates
Stockton, California, United States
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States
Storms Clinical Research Institute
Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Centers
Denver, Colorado, United States
Colorado Allergy and Asthma Centers
Lakewood, Colorado, United States
Clinical Research Atlanta
Atlanta, Georgia, 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
Kansas City Allergy and Asthma
Overland Park, Kansas, United States
Northeast Medical Research Associates
North Dartmouth, Massachusetts, United States
Clinical Research Institute
Minneapolis, Minnesota, United States
Clinical Research Institute
Plymouth, Minnesota, United States
The Clinical Research Center
St Louis, Missouri, United States
Allergy, Asthma and Immunology Associates
Lincoln, Nebraska, United States
The Asthma and Allergy Center
Papillion, Nebraska, United States
Atlantic Research Center
Ocean City, New Jersey, United States
Research Asthma, Sinus and Allergy Centers
Warren Township, New Jersey, United States
AAIR Research Center
Rochester, New York, United States
Island Medical Research
Rockville Centre, New York, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, United States
Allergy Clinic of Tulsa
Tulsa, Oklahoma, United States
Allergy Asthma and Dermatology Research
Lake Oswego, Oregon, United States
Allergy and Consultants of NJ/PA
Collegeville, Pennsylvania, 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
Jane Lee, MD, PA Research Center
Dallas, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Intermountain Clinical Research
Draper, Utah, United States
Asthma, Inc.
Seattle, Washington, United States
Countries
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Other Identifiers
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MP4002
Identifier Type: -
Identifier Source: org_study_id