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Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00710255
Recruitment Status : Completed
First Posted : July 4, 2008
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
David Kaminsky, MD, University of Vermont

Tracking Information
First Submitted Date July 2, 2008
First Posted Date July 4, 2008
Last Update Posted Date October 31, 2016
Study Start Date October 2007
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 3, 2008)
Change in level of cystLTs and adenosine [ Time Frame: Before and after hyperpnea challenge ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 3, 2008)
Change in pH of EBC and change in pulmonary function [ Time Frame: Before and after hyperpnea challenge ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm
Official Title Role of Leukotrienes and Adenosine in Hyperpnea-induced Bronchospasm Determined by Dynamic Analysis of Exhaled Breath Condensate.
Brief Summary 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Asthmatics with exercise induced bronchospasm
Condition Asthma, Exercise Induced
Intervention Procedure: Hyperpnea challenge
5 minutes of dry air hyperpnea to induce bronchospasm
Study Groups/Cohorts Asthmatics
Asthmatics with exercise induced bronchospasm
Intervention: Procedure: Hyperpnea challenge
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 12, 2010)
8
Original Estimated Enrollment
 (submitted: July 3, 2008)
10
Actual Study Completion Date July 2009
Actual Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00710255
Other Study ID Numbers CHRMS 08-023
Merck IISP 32710
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party David Kaminsky, MD, University of Vermont
Study Sponsor University of Vermont
Collaborators Not Provided
Investigators
Principal Investigator: David A. Kaminsky, MD University of Vermont
PRS Account University of Vermont
Verification Date October 2016