Allergic Rhinitis Changes the Sinus Microbiome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01852513
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : April 13, 2016
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: QNASL Drug: Placebo nasal spray Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Allergic Rhinitis Changes the Sinus Microbiome
Study Start Date : January 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

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

Primary Outcome Measures :
  1. Change in sinonasal microbiome during the seasonal allergy exposure [ Time Frame: 2 weeks following treatment in the allergy season ]
    Sinonasal microbiome will be examined prior to allergy season and 2 weeks after treatment with QNASL or placebo in the allergy season

Secondary Outcome Measures :
  1. Symptoms of sneezing, rhinitis, nasal congestion and nasal itching [ Time Frame: 2 weeks ]
    Symptom scores will be recorded by subjects twice daily during the trial. Subjects report four symptoms: sneezing, rhinorrhea, nasal congestion, and nasal itching on a scale from 0 to 3 (0= no symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms).

Other Outcome Measures:
  1. Rhinoconjunctivitis quality-of-life questionnaire (RQLQ) [ Time Frame: Following 2 weeks of treatment with study drug or placebo ]
    Quality of life will be assessed with the self-administered rhinoconjunctivitis quality-of-life questionnaire (RQLQ) as described and validated by Juniper and colleagues.

  2. Nasal eosinophilia [ Time Frame: Following 2 weeks of treatment with study drug or placebo ]
    Total counts of eosinophils recovered from lavages prior to and following treatment

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01852513

United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Jayant Pinto, MD University of Chicago

Responsible Party: University of Chicago Identifier: NCT01852513     History of Changes
Other Study ID Numbers: IRB 12-1812
First Posted: May 13, 2013    Key Record Dates
Last Update Posted: April 13, 2016
Last Verified: April 2016

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases