The purpose of this study is to determine if one allergy medication (0.15% azelastine hydrochloride) is more effective than Placebo alone
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
506
Placebo
0.15% azelastine hydrochloride 822 mcg
Allergy and Asthma Associates
Austin, Texas, United States
Allergy and Asthma Center of Austin
Austin, Texas, United States
Central Texas Health Research
New Braunfels, Texas, United States
Southwest Allergy and Asthma Center, P.A.
San Antonio, Texas, United States
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score(rTNSS)for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)at 14 Days
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 basline as a covariate.
Time frame: baseline and 14 days
Mean Change From Baseline in Instantaneous Total Nasal Symptom Sscore (AM) for the Entire 14-day Study Period Compared to Placebo
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.
Time frame: baseline to 14 Days
Change From Baseline in Instantaneous Total Nasal Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
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 to 14 Days
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Sylvana Research Associates
San Antonio, Texas, United States
Allergy, Asthma Research Center
San Antonio, Texas, United States
Allergy and Asthma Center
Waco, Texas, United States
Change From Baseline in 12-hour Reflective Total Ocular Symptom Score and Instantaneous Total Ocular Symptom Score for the Entire 14-day Study Period Compared to Placebo (AM and PM Combined)
reflective and instantaneous symptom scores (itchy eyes, watery eyes and red eyes) 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 TOSS score is 9 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 to14 Days
Change From Baseline to Visit 4 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) Compared to Placebo in Subjects 18 Years of Age and Older
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. Scores for a series of subsclaes are not combined for a total overall score, rather 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: 14 Days
Change From Baseline on Direct Visual Nasal Exams to 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
Time frame: baseline and 14 days