Nasal Allergen Challenge - Reproducibility of Biomarkers and Effect of Topical Steroid Treatment (NACHO)

August 1, 2018 updated by: Gail Gauvreau
Subjects with allergic asthma developing the required nasal symptoms in response to nasal allergen titration during a screening period will be randomized 1:1 to one of 2 cohorts. All subjects will have repeated nasal challenges with allergen. One cohort will have nasal saline challenge as control. One cohort will have intranasal corticosteroid intervention.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Eligible subjects will be randomized 1:1 to Cohort A or Cohort B. Each cohort will undergo 3 nasal challenges, each separated by 3 weeks. Cohort A will undergo 2 nasal allergen challenges, and 1 nasal diluent challenge. TNSS, PNIF, spirometry, and samples of blood, urine and nasal secretions will be collected until 24h post-challenge to assess reproducibility. Cohort B will undergo 3 nasal allergen challenges; one of the challenge will be conducted after 14 days treatment with placebo, and one challenge will be conducted after 14 days treatment with triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily for a total daily dose of 440 mcg. TNSS, PNIF, spirometry, and samples of blood, urine, nasal secretions will be collected until 24h post-challenge to determine reproducibility, and nasal tissue will be collected 24h post-challenge to determine effect of steroid treatment.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Recruiting
        • Cardio- Respiratory Research Laboratory, Hamilton Health Sciences
        • Contact:
        • Principal Investigator:
          • Gail M Gauvreau, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • allergic rhinitis + mild asthma

Exclusion Criteria:

  • other respiratory disease
  • any medication for treatment of asthma/allergic rhinitis with the exception of infrequent beta-2 agonist.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
0.9% normal saline administered twice daily for 14 days
Drug: Placebo
twice daily for 14 days
Other Names:
  • 0.9% Normal Saline
EXPERIMENTAL: Intranasal Corticosteroid
Triamcinolone acetonide aqueous nasal spray at a dose of 220 mcg administered twice daily (for a total daily dose of 440 mcg) for 14 days
Drug: Triamcinolone Acetonide
220 mcg administered twice daily for 14 days
Other Names:
  • Nasacort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cellular inflammation
Time Frame: 24 hours after nasal allergen challenge
Nasal eosinophils
24 hours after nasal allergen challenge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gail Gauvreau

Investigators

  • Principal Investigator: Gail M Gauvreau, PhD, McMaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 7, 2018

Primary Completion (ANTICIPATED)

February 1, 2019

Study Completion (ANTICIPATED)

February 1, 2019

Study Registration Dates

First Submitted

February 7, 2018

First Submitted That Met QC Criteria

February 7, 2018

First Posted (ACTUAL)

February 13, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DC002544/HIREB3820

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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