Sponsor study identifier
interventional
39
1 country
1
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2013
Actual (reported)Study Completion
June 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
May 8, 2013
Actual (reported)May 13, 2013
Actual (reported)November 2013
Actual (reported)June 2014
Actual (reported)October 9, 2020
Actual (reported)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.
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.
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.
Two weeks following initiation of treatment
QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment
Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University of Chicago
Chicago, Illinois, 60637, United States
Jayant Pinto, MD
University of Chicago
39 participants (actual enrollment reported by the registry).
First Submitted
May 8, 2013
First Posted
May 13, 2013
Study Start
January 2013
Date type not reportedThis date has not been verified as actual or estimated.
Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid
Contact the study team to confirm eligibility.
Primary Completion
November 2013
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
October 9, 2020
Results First Posted
October 9, 2020
Record last verified: 2020-09
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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