NCT01723397

Brief Summary

The objectives of this protocol are:

  1. 1.to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and
  2. 2.to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

October 27, 2016

Completed
Last Updated

January 2, 2017

Status Verified

November 1, 2016

Enrollment Period

1.7 years

First QC Date

November 5, 2012

Results QC Date

September 6, 2016

Last Update Submit

November 7, 2016

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent

    Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.

    Day 2 after one week pretreatment with Nasaleze or placebo.

Study Arms (2)

Nasaleze spray

ACTIVE COMPARATOR

Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge

Drug: Nasaleze SprayBiological: Allergen

Placebo spray

PLACEBO COMPARATOR

Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge

Other: Placebo sprayBiological: Allergen

Interventions

Nasaleze SprayDRUG

Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen

Nasaleze spray
Placebo sprayOTHER

Subjects are treated with placebo nasal spray then challenged with allergen

Placebo spray
AllergenBIOLOGICAL

Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo

Nasaleze sprayPlacebo spray

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females between 18 and 45 years of age.
  • History of grass and/or ragweed allergic rhinitis.
  • Positive skin test to grass and/or ragweed antigen.
  • Positive response to screening nasal challenge.

You may not qualify if:

  • Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
  • Pregnant or lactating women.
  • Upper respiratory infection within 14 days of study start.
  • FEV1\<80% of predicted at screening for subjects with history of mild asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Allergens

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AntigensBiological Factors

Results Point of Contact

Title
Dr. Robert Naclerio
Organization
University of Chicago
rnacleri@surgery.bsd.uchicago.edu
773-702-0080

Study Officials

  • Robert M Naclerio, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2012

First Posted

November 7, 2012

Study Start

November 1, 2012

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

January 2, 2017

Results First Posted

October 27, 2016

Record last verified: 2016-11

Locations

US(1)