A Study to Evaluate the Safety & Effectiveness of a Nasal Spray to Treat Seasonal Allergies
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Drug: Placebo nasal spray
- Registration Number
- NCT00719862
- Lead Sponsor
- Meda Pharmaceuticals
- Brief Summary
The Purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 481
- 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 willing and able to provide informed consent and to participate in all study procedures
- Positive skin test to a prevalent fall allergen
- On focused Nasal Examination, the presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation at either the screening visit or randomization visit will disqualify the subject from the study.
- Other nasal disease(s)likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
- Nasal Surgery or sinus surgery within the previous year
- Chronic sinusitis-more than 3 episodes a year
- Planned travel outside of the study area during the study period
- The use of any investigational drug within 30 days prior to screening. No investigational products are permitted for use during the conduct of the study.
- Presence of any hypersensitivity to drugs similar to azelastine and to either sorbital or sucralose (Splenda brand sweetener)
- Women who are pregnant or nursing
- Women of childbearing potential who are not abstinent or not practicing medically acceptable method of contraception
- Respiratory tract infection within 14 days prior to screening
- Respiratory tract infections requiring antibiotic treatment 14 days prior to screening
- Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not for more often tha twice a week) and who do not have nocturnal awakening as a result of asthma are eligible for enrollment
- Significant pulmonary disease including COPD
- Clinically significant arrythmia 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 laboratory findings, which in the opinion of the investigator or sponsor's medical monitor, might significantly alter the absorption, distribution, metabolism, or excretion of study drug; that might significantly affect the subject's ability to complete this trial; or their safety in this trial
- Clinically relevant abnormal physical findings which, in the opinion of the investigator, would interfere with the objectives of the study or that may preclude compliance with the study procedures.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.15% azelastine hydrochloride nasal spray 0.15% azelastine hydrochloride Nasal Spray 0.15% azelastine hydrochloride Placebo Nasal Spray Placebo nasal spray 0mg Placebo Nasal Spray
- Primary Outcome Measures
Name Time Method Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined)at 14 Days baseline and 14 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 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 Mean Change From Baseline in Instantaneous Total Nasal Symptom Score (tNSS) (AM) for the Entire 14-day Study Period Compared to Placebo baseline and 14 days End of 24 hour dosing interval: This endpoint is change from baseline in instantaneous tNSS for the 14-day study period compared to placebo to observe if the duration of efficacy lasts 24 hours on a day to day basis. Instantaneous tNSS consists of runny nose, itchy nose, nasal congestion, and sneezing. Each symptom is rated on a scale from 0-3: 0=none, 1=mild, 2=moderate, and 3=severe.
Least square means 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 baseline as a covariate.Change From Baseline in 12 Hour Instantaneous Total Nasal Sytmptom Score (AM and PM Combined)at 14 Days baseline and 14-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.
Least square means 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.Change From Baseline in 12-hour Reflective SSCS for the Entire 14-day Study Period Compared to Placebo (Am and PM Combined) baseline and 14-days Reflective secondary symptom 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.
Least square means 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.Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at 14 Days baseline and 14 Days A 28-item RQLQ was completed on Day 1 and Day 14 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.
Total overall score is not calculated by adding all subscales scores for an overall score. 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 at 14 Days baseline and 14 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 (34)
Allergy Consultants PA
🇺🇸Verona, New Jersey, United States
UPMC-ENT
🇺🇸Pittsburgh, Pennsylvania, United States
Kansas City Allergy and Asthma
🇺🇸Overland Park, Kansas, United States
OIAA Clinical Research, LLC
🇺🇸Edmond, Oklahoma, United States
Advanced Healthcare, SC
🇺🇸Milwaukee, Wisconsin, United States
Atlanta Allergy and Asthma Clinic
🇺🇸Woodstock, Georgia, United States
Allergy and Asthma Medical Group and Research Center
🇺🇸San Diego, California, United States
Allergy and Asthma Specialist Medical Group
🇺🇸Huntington Beach, California, United States
Bensch Research Associates
🇺🇸Stockton, California, United States
Valley Clinical Research
🇺🇸Easton, Pennsylvania, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Allergy, Asthma and Respiratory Care medical Center
🇺🇸Long Beach, California, United States
Allergy & Asthma Associates of Santa Clara Valley Research Cntr
🇺🇸San Jose, California, United States
Colorado Allergy and Asthma centers, PC
🇺🇸Lakewood, Colorado, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Aeroallergy Research Laboratories of Savannah
🇺🇸Savannah, Georgia, United States
RX R+D
🇺🇸Metairie, Louisiana, United States
Chesapeake Clinical Research, Inc
🇺🇸Baltimore, Maryland, United States
Sneeze, Wheeze and Itch Associates
🇺🇸Normal, Illinois, United States
The Clinical Research Center
🇺🇸St. Louis, Missouri, United States
Institute for Asthma and Allergy PC
🇺🇸Wheaton, Maryland, United States
Clinical Research Institute
🇺🇸Plymouth, Minnesota, United States
AAIR Research Center
🇺🇸Rochester, New York, United States
Las Vegas Physicians Research Group
🇺🇸Henderson, Nevada, United States
Allergy and Asthma Research NJ inc
🇺🇸Mount Laurel, New Jersey, United States
Asthma and Allergy Research Associates
🇺🇸Chester, Pennsylvania, United States
Asthma, Nasal Disease & Allergy Research Center of New England
🇺🇸Providence, Rhode Island, United States
Jane Lee, MD, PA Research Center
🇺🇸Dallas, Texas, United States
Western Sky Medical Research
🇺🇸El Paso, Texas, United States
Pharmaceutical Research & Consulting Inc
🇺🇸Dallas, Texas, United States
Allergy Asthma Research Institute
🇺🇸Waco, Texas, United States
Allergy and Asthma Center of Michigan
🇺🇸Novi, Wisconsin, United States
Midwest Allergy and Asthma Clinic
🇺🇸Omaha, Nebraska, United States
The Asthma and Allergy Center
🇺🇸Papillion, Nebraska, United States