Phase 4
N=39
Allergic Rhinitis Changes the Sinus Microbiome
Seasonal Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT01852513 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Total Nasal Symptom Score (TNSS) — 67.1; 78.0 score on a scale — p=0.391
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- QNASL (Drug); Placebo nasal spray (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Nasal Symptom Score (TNSS) |
67.1; 78.0 | 0.391 |
| PRIMARY Change in RQLQ Score From Baseline to Two Weeks |
1.2; 1.3 | 0.789 |
| PRIMARY Change in Percent Eosinophils From Baseline to Two Weeks |
1.5; 2.1 | 0.778 |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01852513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.