The investigators hypothesize that treatment with QNASL will reduce nasal mucosal inflammation induced by the allergy season and prevent the changes in the microbiome caused by the allergy season.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
39
University of Chicago
Chicago, Illinois, United States
Total Nasal Symptom Score (TNSS)
The Total Nasal Symptom Score (TNSS) is the sum of scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea using a four point scale (0-3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 12. TNSS was assessed daily and summed over 14 days; thus, the total score ranges from 0 to 168, with higher scores indicating a worse outcome.
Time frame: Two weeks following initiation of treatment
Change in RQLQ Score From Baseline to Two Weeks
The Rhinoconjunctivitis Quality Of Life Questionnaire (RQLQ) is a self-administered disease-specific health-related quality of life instrument that measures the functional impairments that are most troublesome to adult patients as a result of their seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. There are 28 items each asking about symptoms during the previous week. Seven domains of activity limitation are included: activities (3 "patient-specific") limitation, sleep problems (3 items), nose symptoms (4 items), eye symptoms (4 items), non-nose/eye symptoms (7 items), practical problems (3 items) and emotional function (4 items)). Each item is reported using a 7-point scale (0 = not impaired at all, 6 = severely impaired), and a total score is calculated by averaging over all items (range 0-7). Higher scores reflect lower quality of life.
Time frame: Two weeks following initiation of treatment
Change in Percent Eosinophils From Baseline to Two Weeks
The percentage of nasal eosinophils recovered from nasal lavage was assessed at baseline and after two weeks of treatment.
Time frame: Two weeks following initiation of treatment
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