Allergic Rhinitis Changes the Sinus Microbiome

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2013 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
Robert Naclerio, University of Chicago
ClinicalTrials.gov Identifier:
NCT01852513
First received: May 8, 2013
Last updated: May 10, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Seasonal Allergic Rhinitis
Drug: QNASL
Drug: Placebo nasal spray
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Allergic Rhinitis Changes the Sinus Microbiome

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Change in sinonasal microbiome during the seasonal allergy exposure [ Time Frame: 2 weeks following treatment in the allergy season ] [ Designated as safety issue: No ]
    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:
  • Symptoms of sneezing, rhinitis, nasal congestion and nasal itching [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    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:
  • Rhinoconjunctivitis quality-of-life questionnaire (RQLQ) [ Time Frame: Following 2 weeks of treatment with study drug or placebo ] [ Designated as safety issue: No ]
    Quality of life will be assessed with the self-administered rhinoconjunctivitis quality-of-life questionnaire (RQLQ) as described and validated by Juniper and colleagues.

  • Nasal eosinophilia [ Time Frame: Following 2 weeks of treatment with study drug or placebo ] [ Designated as safety issue: No ]
    Total counts of eosinophils recovered from lavages prior to and following treatment


Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: QNASL nasal spray
QNASL 320 mcg once-daily administered as two sprays in each nostril; 2 weeks of treatment
Drug: QNASL
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01852513

Contacts
Contact: James Lane, BS 773-702-5889 jlane@surgery.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Principal Investigator: Robert Naclerio, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Robert Naclerio, MD University of Chicago
  More Information

No publications provided

Responsible Party: Robert Naclerio, Professor, University of Chicago
ClinicalTrials.gov Identifier: NCT01852513     History of Changes
Other Study ID Numbers: IRB 12-1812
Study First Received: May 8, 2013
Last Updated: May 10, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 28, 2014