The purpose of this study is to determine if two allergy medications are more effective than placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
581
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (AM and PM Combined) at 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.
Time frame: baseline and 28 days
Change From Baseline in Instantaneous Total Nasal Symprom scoreS Compared to Placebo (AM and PM Combined)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.
Time frame: baseline and 28 days
Change From Baseline in 12-hour Reflective Secondary Symptom Complex Score Compared to Placebo (AM and PM Combined)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.
Time frame: baseline and 28 days
Change From Baseline in Rinoconjunctivitis Quality of Life Questionnaire 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.
Time frame: baseline and 28 Days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Allergy and Asthma Specialist Medical Group
Huntington Beach, California, United States
Allergy, Asthma and Respiratory Care medical Center
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
Allergy and Asthma Medical Group and Research Center
San Diego, California, United States
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States
Asthma and Allergy Associates
Colorado Springs, Colorado, United States
The William Storms Allergy Clinic
Colorodo Springs, Colorado, United States
Atlanta Allergy and Asthma Clinic
Woodstock, Georgia, United States
...and 33 more locations
Change From Baseline on Direct Visual Nasal Exams 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
Time frame: baseline and 28 days