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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00710255
Other study ID # CHRMS 08-023
Secondary ID Merck IISP 32710
Status Completed
Phase N/A
First received July 2, 2008
Last updated October 27, 2016
Start date October 2007
Est. completion date July 2009

Study information

Verified date October 2016
Source University of Vermont
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date July 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 75 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Procedure:
Hyperpnea challenge
5 minutes of dry air hyperpnea to induce bronchospasm

Locations

Country Name City State
United States Vermont Lung Center Colchester Vermont

Sponsors (1)

Lead Sponsor Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in level of cystLTs and adenosine Before and after hyperpnea challenge No
Secondary Change in pH of EBC and change in pulmonary function Before and after hyperpnea challenge No