Allergic Rhinitis Changes the Sinus Microbiome

NCT ID: NCT01852513

Last Updated: 2020-10-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-06-30

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.

Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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QNASL nasal spray

QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment

Group Type ACTIVE_COMPARATOR

QNASL

Intervention Type DRUG

Placebo nasal spray

Placebo nasal spray once-daily administered as two sprays in each nostril; 2 weeks of treatment

Group Type PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type DRUG

Interventions

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QNASL

Intervention Type DRUG

Placebo nasal spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Males and females between 18 and 55 years of age.
2. Two year history of seasonal allergic rhinitis.
3. Positive skin test to grass and/or tree antigen.

Exclusion Criteria

1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
2. Pregnant or lactating women.
3. Subjects treated with systemic steroids during the previous 30 days.
4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
5. Subjects treated with oral antihistamine/decongestants during the previous seven days.
6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
7. Subjects treated with immunotherapy and are escalating their dose.
8. Subjects on chronic anti-asthma medications.
9. Subjects with polyps in the nose or a significantly displaced septum.
10. Upper respiratory infection within 14 days prior to study start.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jayant Pinto, MD

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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IRB 12-1812

Identifier Type: -

Identifier Source: org_study_id

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