Back to resultsAllergic Rhinitis Changes the Sinus Microbiome
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
QNASL
Placebo nasal spray
Sponsored by
About this trial
This is an interventional prevention trial for Seasonal Allergic Rhinitis
Eligibility Criteria
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.
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
QNASL nasal spray
Placebo nasal spray
Arm Description
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
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01852513
Brief Title
Allergic Rhinitis Changes the Sinus Microbiome
Official Title
Allergic Rhinitis Changes the Sinus Microbiome
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QNASL nasal spray
Arm Type
Active Comparator
Arm Description
QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment
Arm Title
Placebo nasal spray
Arm Type
Placebo Comparator
Arm Description
Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment
Intervention Type
Drug
Intervention Name(s)
QNASL
Intervention Type
Drug
Intervention Name(s)
Placebo nasal spray
Primary Outcome Measure Information:
Title
Total Nasal Symptom Score (TNSS)
Description
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
Title
Change in RQLQ Score From Baseline to Two Weeks
Description
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
Title
Change in Percent Eosinophils From Baseline to Two Weeks
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jayant Pinto, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Allergic Rhinitis Changes the Sinus Microbiome
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