The purpose of this study was to determine if two allergy medications are more effective than placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
526
0.15% azelastine hydrochloride 1644 mcg daily
0.1% azelastine hydrochloride 1096 mcg daily
0 mcg Placebo daily
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo
rTNSS 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. (maximum 12 points per assessment.) 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 baseline as a covariate.
Time frame: baseline and 14 days
Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo
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.
Time frame: baseline and 14 Days
Change From Baseline in the 12-hour Reflective Secondary Symptom Complex Score for the Entire 14-day Study Period Compared to Placebo
Reflective secondary symptom scores (SSCS) (post-nasal drip, itchy eyes, cough and headache) 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.
Time frame: baseline and 14 days
Change From Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Patients 18 Years of Age and Older
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Center of Research Excellence, LLC
Oxford, Alabama, 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
Allergy Associates Medical Group Inc
San Diego, California, United States
Storms Clinical Research Institute
Colorado Springs, Colorado, United States
Colorado Allergy and Asthma Centers
Denver, Colorado, United States
ENTA Allergy, Head and Neck Associates
Decatur, Illinois, United States
Sneeze, Wheeze and Itch Associates
Normal, Illinois, United States
Family Allergy and Asthma Reserach
Louisville, Kentucky, United States
...and 19 more locations
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. 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.
Time frame: baseline and 14 days
Change From Baseline on Direct Visual Nasal Exams
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
Time frame: 14 days