A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Perennial Allergies
- Conditions
- Perennial Allergic Rhinitis
- Interventions
- Registration Number
- NCT00712920
- Lead Sponsor
- Meda Pharmaceuticals
- Brief Summary
The purpose of this study is to determine if two allergy medications are more effective than placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 581
- Male and female patients 12 years of age and older
- Must be in generally good health
- Must meet minimum symptom requirements, as specified in protocol
- Must be willing and able to provide informed consent and participate in all study procedures
- 2-year history of PAR
- Positive skin test to cockroach, dust mite, mold or cat/dog dander
- On nasal examination, presence of any nasal mucosal erosion, nasal ulceration or nasal septal perforation at the screening or randomization visit
- Nasal diseases likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, significant polyposis or nasal structural abnormalities
- Nasal surgery or sinus surgery within the previous year
- The use of any investigational drug within 30 days
- Presence of any hypersensitivity to drugs similar to azelastine and to either sorbitol or sucralose
- Women who are pregnant or nursing
- Women of child-bearing potential who are not abstinent and not practicing a medically acceptable method of contraception
- Respiratory tract infection within 2 weeks of screening
- Respiratory tract infections requiring oral antibiotic treatment within 2 weeks of screening
- Patients with asthma with the exception of mild, intermittent
- Significant pulmonary disease including COPD
- Patients with arrhythmia
- Patients with a known history of alcohol or drug abuse
- Existence of any surgical or medical condition, which in the opinion of the investigator or sponsor may significantly alter the absorption, distribution, metabolism or excretion of study drug.
- Clinically relevant abnormal physical findings within one week of randomization
- Overnight abscences from home for more than 3 nights
- Employees of the research center or private practice and family members are excluded
- Patients who received prohibited medications within specified timepoints in protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Placebo Placebo 2 0.15% azelastine hydrochloride 0.15% azelastine hydrochloride 1644 mcg/2 sprays per nostril 2 times a day for 4 weeks 3 0.1% azelastine hydrochloride 0.1% azelastine hydrochloride 1096 mcg/2 sprays per nostril 2 times a day for 4 weeks
- Primary Outcome Measures
Name Time Method Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 28 Days. baseline and 28 days Reflective total nasal symptom score consisting of Runny nose, itchy nose, nasal Congestion, and Sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day
Least square means (LS Mean) was controlled for study day as the within-patient effect, treatment group and site as the between-patient effects, treatment by-study day interaction, and basline as a covariate.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)and 28 Days baseline and 28 days instantaneous (subjects rate how they feel "right now") total nasal symptom score consisting of runny nose, itchy nose, nasal congestion, and sneezing was assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible score is 24 per day.
Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)and 28 Days baseline and 28 days Reflective secondary symptom complex scores (SSCS) (post-nasal drip, itchy eyes, cough and headacdhe) were assessed twice daily. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe. Total possible SSCS score is 24 per day.
Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire and 28 Days baseline and 28 Days A 28-item RQLQ was completed on Day 1 and Day 28 or Early temination. The RQLQ consists of 7 domains rated on a 7 point scale with 0 being not troubled by the allergy symptoms, and 6 being extremely troubled/all of the time. Domain score will be calculated from the mean score of all items in the domain. Overall score will be calculated from the mean score of all items.
Change From Baseline on Direct Visual Nasal Exams and 28 Days baseline and 28 days Examination of head and neck (scale: None, Mild, Moderate, Severe) for Epistaxis, Mucosal Edema, Nasal Discharge, Mucosal erythema, Mucosal Bleeding, and Crusting of mucosa. Nasal irratation was rated: 0 = None, Grade 1A = focal irritation, Grade 1B = superficial mucosal erosion, Grade 2 = moderate mucosal erosion, Grade 3 = ulceration, Grade 4 = septal perforation
Trial Locations
- Locations (42)
National Allergy, Asthma and Urticaria of Charleston
🇺🇸Charleston, South Carolina, United States
AAIR Research Center
🇺🇸Rochester, New York, United States
Allergy Asthma and Dermatology Research
🇺🇸Lake Oswego, Oregon, United States
Allergy and Asthma Center
🇺🇸Waco, Texas, United States
Virginia Adult & Pediactric Allergy & Asthma, PC
🇺🇸Richmond, Virginia, United States
Advanced Healthcare, SC
🇺🇸Milwaukee, Wisconsin, United States
Allergy, Asthma and Clinical Research Center
🇺🇸Oklahoma City, Oklahoma, United States
Allergy and Asthma Associates
🇺🇸Austin, Texas, United States
North Carolina Clinical Research
🇺🇸Raleigh, North Carolina, United States
Atlantic Research Center
🇺🇸Ocean, New Jersey, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Clinical Research Institute of Southern Oregon, PC
🇺🇸Medford, Oregon, United States
Allergy and Consultants of NJ/PA
🇺🇸Collegeville, Pennsylvania, United States
AARA Research Center
🇺🇸Dallas, Texas, United States
Pharmaceutical Research & Consulting Inc
🇺🇸Dallas, Texas, United States
Biogenics Research Institute
🇺🇸San Antonio, Texas, United States
Sylvana Research Associates
🇺🇸San Antonio, Texas, United States
Dr. Perin
🇺🇸Teaneck, New Jersey, United States
Asthma, Nasal Disease & Allergy Research Center of New England
🇺🇸Providence, Rhode Island, United States
Central Texas Research
🇺🇸New Braunfels, Texas, United States
Allergy Associates Medical Group Inc
🇺🇸San Diego, California, United States
Allergy and Asthma Medical Group and Research Center
🇺🇸San Diego, California, United States
Bernstein Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Asthma, Inc.
🇺🇸Seattle, Washington, United States
New Horizon's Clinical Research
🇺🇸Cincinnati, Ohio, United States
Asthma and Allergy Research Associate
🇺🇸Upland, Pennsylvania, United States
Allergy Research Foundation
🇺🇸Los Angeles, California, United States
Southern California Research
🇺🇸Mission Viejo, California, United States
Allergy and Asthma Specialist Medical Group
🇺🇸Huntington Beach, California, United States
Allergy, Asthma and Respiratory Care medical Center
🇺🇸Long Beach, California, United States
Allergy and Asthma Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Asthma and Allergy Associates
🇺🇸Colorado Springs, Colorado, United States
Sneeze, Wheeze and Itch Associates
🇺🇸Normal, Illinois, United States
The William Storms Allergy Clinic
🇺🇸Colorodo Springs, Colorado, United States
Atlanta Allergy and Asthma Clinic
🇺🇸Woodstock, Georgia, United States
Kansas City Allergy and Asthma
🇺🇸Overland Park, Kansas, United States
Clinical Research Institute
🇺🇸Plymouth, Minnesota, United States
Northeast Medical Research Associates
🇺🇸North Dartmouth, Massachusetts, United States
Allergy and Asthma Research NJ inc
🇺🇸Mount Laurel, New Jersey, United States
Las Vegas Physicians Research Group
🇺🇸Henderson, Nevada, United States
Institute for Asthma and Allergy PC
🇺🇸Wheaton, Maryland, United States
The Clinical Research Center
🇺🇸St. Louis, Missouri, United States