Allergic Rhinitis Changes the Sinus Microbiome

NCT01852513 | Completed Phase 4 Results

• 1 other identifier: IRB 12-1812
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (3)

• Total Nasal Symptom Score (TNSS)

  The Total Nasal Symptom Score (TNSS) is the sum of scores for each of nasal congestion, sneezing, nasal itching, and rhinorrhea using a four point scale (0-3), where 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 12. TNSS was assessed daily and summed over 14 days; thus, the total score ranges from 0 to 168, with higher scores indicating a worse outcome.

  Two weeks following initiation of treatment

• Change in RQLQ Score From Baseline to Two Weeks

  The Rhinoconjunctivitis Quality Of Life Questionnaire (RQLQ) is a self-administered disease-specific health-related quality of life instrument that measures the functional impairments that are most troublesome to adult patients as a result of their seasonal or perennial rhinoconjunctivitis of either allergic or non-allergic origin. There are 28 items each asking about symptoms during the previous week. Seven domains of activity limitation are included: activities (3 "patient-specific") limitation, sleep problems (3 items), nose symptoms (4 items), eye symptoms (4 items), non-nose/eye symptoms (7 items), practical problems (3 items) and emotional function (4 items)). Each item is reported using a 7-point scale (0 = not impaired at all, 6 = severely impaired), and a total score is calculated by averaging over all items (range 0-7). Higher scores reflect lower quality of life.

  Two weeks following initiation of treatment

• Change in Percent Eosinophils From Baseline to Two Weeks

  The percentage of nasal eosinophils recovered from nasal lavage was assessed at baseline and after two weeks of treatment.

  Two weeks following initiation of treatment

Study Arms (2)

QNASL nasal spray

ACTIVE COMPARATOR

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

Drug: QNASL

Placebo nasal spray

PLACEBO COMPARATOR

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

Drug: Placebo nasal spray

Interventions

QNASL DRUG

QNASL nasal spray

Placebo nasal spray DRUG

Placebo nasal spray

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr. Jayant Pinto, PI
• Organization: The University of Chicago

jpinto@surgery.bsd.uchicago.edu

773-702-6727

Study Officials

• Jayant Pinto, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 13, 2013
• Study Start: January 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: June 1, 2014
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-09

Locations

US (1)