Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037427
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2002-05-16
Brief Title:
Airway Responses Following Chlorine Gas Exposure
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine lung airway responses following chlorine gas exposure
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 04 ppm 2 chlorine at 10 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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
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 04 ppm 2 chlorine at 10 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
The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System PRS record
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL069664 | NIH | None | httpsreporternihgovquickSearchR01HL069664 |