Allergic Rhinitis Changes the Sinus Microbiome

Study Overview
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Brief Summary
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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.

Official Title
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Allergic Rhinitis Changes the Sinus Microbiome

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: QNASL
* Drug: Placebo nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females between 18 and 55 years of age. Two year history of seasonal allergic rhinitis. Positive skin test to grass and/or tree antigen. Exclusion Criteria: Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. Pregnant or lactating women. Subjects treated with systemic steroids during the previous 30 days. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days. Subjects treated with oral antihistamine/decongestants during the previous seven days. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days. Subjects treated with immunotherapy and are escalating their dose. Subjects on chronic anti-asthma medications. Subjects with polyps in the nose or a significantly displaced septum. Upper respiratory infection within 14 days prior to study start.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: QNASL nasal spray<br>QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment | Drug: QNASL<br> <br> |
| Placebo Comparator: Placebo nasal spray<br>Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment | Drug: Placebo nasal spray<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |