A Study Evaluating the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
NCT ID: NCT00740792
Last Updated: 2012-09-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
776 participants
INTERVENTIONAL
2008-08-31
2008-11-30
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; the symptom of postnasal drip will be rated, 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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azelastine HCl/fluticasone propionate
nasal spray
azelastine HCl/fluticasone propionate
azelastine HCl 548 mcg/ fluticasone propionate 200 mcg one spray per nostril BID
azelastine HCL
nasal spray
azelastine Hcl
azelastine Hcl 548 mcg one spray per nostril BID
fluticasone propionate
nasal spray
fluticasone propionate
fluticasone propionate 200 mcg one spray per nostril BID
placebo
nasal spray
placebo
placebo one spray per nostril BID
Interventions
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azelastine HCl/fluticasone propionate
azelastine HCl 548 mcg/ fluticasone propionate 200 mcg one spray per nostril BID
azelastine Hcl
azelastine Hcl 548 mcg one spray per nostril BID
fluticasone propionate
fluticasone propionate 200 mcg one spray per nostril BID
placebo
placebo one spray per nostril BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Provide written informed consent/pediatric assent. If the subject is a minor, parent or legal guardian must give written informed consent
* Subjects must have moderate-to-severe rhinitis, defined as having one or more of the following:
1. Sleep disturbance
2. Impairment of daily activities, leisure and/or sport
3. Impairment of school or work
4. Troublesome symptoms
* Screening Visit: Have a 12-hour reflective TNSS of at least 8 of 12 and a congestion score of 2 or 3 on Visit 1
* Randomization Visit: Have a 12-hour reflective TNSS (AM or PM) of at least 8 on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) during the Lead-in Period.
* Randomization Visit: Have an AM or PM 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments (one of which was within 2 days of Day 1, and can include the morning of Day 1) Randomization Visit: Have an instantaneous TNSS score of 8 or more at time point zero, just prior to beginning the onset of action assessment
* Have taken at least 10 doses of the lead-in medication
* Willing and able to comply with the study requirementsAt least a 2-year history of SAR during Fall allergy season
* The presence of IgE-mediated hypersensitivity to a local Fall pollen, confirmed by a positive response to skin prick within the last year. A positive response is defined as a wheal diameter of at least 3 mm larger than the negative control.
* General good health and free of disease or concomitant treatment that could interfere with the interpretation of the study results
* Subjects receiving immunotherapy injections (antigen desensitization) must be on a stable maintenance regimen for at least 30 days before the first study visit
* Subjects currently receiving sublingual immunotherapy are excluded. A 6-month washout period is required following the last dose of sublingual immunotherapy.
Exclusion Criteria
* Other nasal disease(s) likely to affect deposition of intranasal medication
* Nasal surgery or sinus surgery within the previous year.
* Chronic sinusitis - more than 3 episodes per year
* Planned travel outside of the pollen area during the study period
* The use of any investigational drug within 30 days prior to Day -7.
* Presence of any hypersensitivity to drugs similar to azelastine hydrochloride or fluticasone propionate
* Women who are pregnant or nursing
* Women of childbearing potential who are not abstinent or not practicing a medically acceptable method of contraception\*
* Respiratory Tract Infections within 14 days prior to Day -7
* Respiratory Tract Infections requiring antibiotic treatment 14 days prior to Day -7
* Asthma (with the exception of intermittent asthma).
* Significant pulmonary disease including COPD
* Clinically significant arrhythmia or symptomatic cardiac conditions
* A known history of alcohol or drug abuse within the last 2 years
* Existence of any surgical or medical condition or physical or laboratory findings that could interfere with study result interpretation.
* Patients with a history of Glaucoma
* Clinically relevant abnormal physical findings within 1 week of randomization that may preclude compliance with the study procedures
* Employees of the research center or private practice and their family members are excluded
* Subjects who participated in protocol MP4001 or MP4002
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
AABI Associates Medical Group
Fountain Valley, California, United States
William Ebbling, MD Inc
Fresno, California, United States
Allergy & Asthma Care Center of So. Cal
Long Beach, California, United States
Allergy Research Foundation
Los Angeles, California, United States
Southern California Research
Mission Viejo, California, United States
Allergy Associates Medical Group Inc
San Diego, California, United States
Bensch Research Associates
Stockton, California, United States
Storms Clinical Research Institute
Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Centers
Denver, Colorado, United States
Clinical Research Atlanta
Atlanta, Georgia, United States
Atlanta Allergy and Asthma Clinic
Stockbridge, 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 Reseacrh Institute
Minneapolis, Minnesota, United States
Clinical Research Institute
Plymouth, Minnesota, United States
The Clinical Research Center
St Louis, Missouri, United States
The Asthma and Allergy Center
Papillion, Nebraska, United States
Atlantic Research Center
Ocean City, New Jersey, United States
Princeton Center for Clinical Research
Skillman, New Jersey, United States
Research Asthma, Sinus and Allergy Centers
Warren Township, New Jersey, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Bernstein Clinical Research Center
Cincinnati, Ohio, 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
Southwest Allergy and Asthma Center, P.A.
San Antonio, Texas, United States
Sylvana Research Associates
San Antonio, Texas, United States
Intermountain Clinical Research
Draper, Utah, United States
Countries
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Other Identifiers
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MP4004
Identifier Type: -
Identifier Source: org_study_id