Allergic Rhinitis Changes the Sinus Microbiome

The University of Chicago

Status and phase: Completed; Phase 4

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Placebo nasal spray; Drug: QNASL

Study type: Interventional

Funder types: Other

Identifiers

NCT01852513

IRB 12-1812

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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39 participants in 2 patient groups, including a placebo group

QNASL nasal spray

Active Comparator group

Description:

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

Treatment:

Drug: QNASL

Placebo nasal spray

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo nasal spray