Airway Responses Following Chlorine Gas Exposure

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00037427
First received: May 16, 2002
Last updated: June 23, 2005
Last verified: May 2005
  Purpose

To determine lung airway responses following chlorine gas exposure.


Condition
Asthma
Lung Diseases

Study Type: Observational
Study Design: Observational Model: Case Control

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 2001
Estimated Study Completion Date: July 2004
Detailed Description:

DESIGN NARRATIVE:

The specific aims of the study are to determine: (1) the effects of asthma with pre-existing airway hyper reactivity on the pulmonary function and airway reactivity and inflammation responses to chlorine; (2) the effects of chlorine concentration on the pulmonary function and airway reactivity and inflammation responses to chlorine; and (3) to assess the time dynamics of the pulmonary function and airway reactivity and inflammation responses to chlorine. It is hypothesized that both airway hyperactivity and higher chlorine concentration will result in larger changes in pulmonary function and airway reactivity and inflammation responses, and that these changes will have differential time courses following chlorine exposure. This study uses two controlled human exposure experiments, utilizing a single-blind, repeated-measures, and counter- balanced design. The two subject groups for both experiments will consist of 21 individuals with no airway hyperactivity, and 21 individuals with both asthma and airway hyperactivity. In Experiment One, subjects are exposed for 15 minutes separately to each of: (1) chlorine at 0.4 ppm; (2) chlorine at 1.0 ppm; and (3) filtered air (Control). Pulmonary function and airway reactivity are measured immediately pre-exposure and 1 and 20 hours post-exposure. Airway inflammation, as determined by cellular and biochemical components from sputum-induction, is measured 65 hours pre-exposure and 20 hours post-exposure. In Experiments Two, subjects are exposed for 15 minutes separately to each of: (1) chlorine (concentration determined from Experiment One); (2) filtered air (Control). Pulmonary function and airway reactivity are measured immediately pre-exposure and at 3 and 72 hours post-exposure. Sputum-induction is performed 65 hours pre-exposure and at 3 and 72 hours post-exposure. The results of this study will provide information on a major irritant chemical relevant to occupational environments. Specially, the susceptibility of a large sub-population at increased risk, the dose-response effects, and the post-exposure time dynamics of the effects of chlorine gas will be determined.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00037427

Sponsors and Collaborators
Investigators
Investigator: Colin Solomon University of California at San Francisco
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00037427     History of Changes
Other Study ID Numbers: 1170
Study First Received: May 16, 2002
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 29, 2014