- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00710255
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
Conditions
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.
Sponsor
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRMS 08-023
- Merck IISP 32710
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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