Human Rhinovirus Infection and Airway Remodeling Mediators

NCT01847768 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2015-08-14

No results posted yet for this study

Summary

In this study, the following subjects will be exposed to human rhinovirus (HRV):

* those with classification of mild-moderate asthma
* healthy control subjects.

The investigators will study the kinetics of HRV-induced inflammatory and remodeling responses in a well characterized group of asthmatic subjects and compare these outcomes to those in a healthy, non-asthmatic control group.

Conditions

Interventions

BIOLOGICAL

GMP-grade HRV-39

Experimental rhinovirus infection: an FDA approved, GMP-grade HRV-39 stock (gift from Dr. Ronald B. Turner, University of Virginia), which has now been approved by Health Canada for human experimental use, will be used in this study.

PROCEDURE

Bronchoalveolar Lavage

DRUG

Methacholine Inhalation Challenge

The purpose of this test is to determine if lung airways narrow by more than 20%, which confirms an asthma diagnosis.

PROCEDURE

Nasal Lavage

PROCEDURE

Nasal Scrapings

This process uses a rhinoprobe to gently scrape the mucosal lining of the nose

PROCEDURE

Bronchial Brushings

PROCEDURE

Lung Mucosal Biopsy

PROCEDURE

Allergen Skin Prick Testing

For the purposes of this study, allergy skin testing will be done with the following aero-allergens: cat epidermis, dog epidermis, horse, grass mix, tree mix, weed mix, ragweed and house dust mite, along with a histamine positive control and a buffer \& glycerol negative control.

PROCEDURE

Venipuncture

Peripheral blood for assessment of neutralizing antibodies to HRV-39

PROCEDURE

Bronchoscopy

A small flexible tube the size of a pencil, with a video-camera built into the tip (called a bronchoscope), will be inserted through the nose or mouth and down into the lungs.

PROCEDURE

Spirometry

Sponsors & Collaborators

  • Asthma and Allergic Diseases Cooperative Research Centers

    collaborator OTHER
  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • David Proud, PhD · University of Calgary

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01847768 on ClinicalTrials.gov