Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm

October 27, 2016 updated by: David Kaminsky, MD, University of Vermont

Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm Determined by Dynamic Analysis of Exhaled Breath Condensate.

This research is being conducted to help us better understand what causes exercise induced asthma. The investigators hypothesize that two types of chemicals, cysteinyl leukotrienes and adenosine, play an important role. The investigators will be measuring these chemicals in the exhaled breath of volunteers with exercise induced asthma as they undergo a test to mimic exercise induced asthma. The investigators will determine how the levels of these chemicals change in association with how lung function changes before, during and after an episode of exercise induced asthma.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

8

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

    • Vermont
      • Colchester, Vermont, United States, 05446
        • Vermont Lung Center

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

12 years to 75 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Asthmatics with exercise induced bronchospasm

Description

Inclusion Criteria:

  • Physician diagnosed asthma
  • Age 12-75 yrs
  • FEV1 > 70% predicted
  • HIB response > 10 %
  • No smoking last 6 mo and < 10 pack yrs
  • No URI last 4 weeks
  • No asthma exacerbation last 4 weks
  • Able to withhold SABA > 8 hrs and LABA > 24 hrs

Exclusion Criteria:

  • Other lung disease
  • Cardiac disease or other condition that would preclude safe participation, on theophylline or leukotriene modifiers

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asthmatics
Asthmatics with exercise induced bronchospasm
5 minutes of dry air hyperpnea to induce bronchospasm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in level of cystLTs and adenosine
Time Frame: Before and after hyperpnea challenge
Before and after hyperpnea challenge

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in pH of EBC and change in pulmonary function
Time Frame: Before and after hyperpnea challenge
Before and after hyperpnea challenge

Collaborators and Investigators

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

Investigators

  • Principal Investigator: David A. Kaminsky, MD, University of Vermont

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

October 1, 2007

Primary Completion (ACTUAL)

March 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

July 2, 2008

First Submitted That Met QC Criteria

July 3, 2008

First Posted (ESTIMATE)

July 4, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

October 31, 2016

Last Update Submitted That Met QC Criteria

October 27, 2016

Last Verified

October 1, 2016

More Information

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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