AsthmaNCT00037427
Airway Responses Following Chlorine Gas Exposure
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine lung airway responses following chlorine gas exposure. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Sep 2001to Jul 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine lung airway responses following chlorine gas exposure.
Read the 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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2002 (estimated)
- Study startSep 2001
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Colin Solomon, University of California at San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00037427
- Sponsor's protocol ID
- 1170
- Other IDs
- R01HL069664
- Status last verified
- May 2005
- First submitted
- 16 May 2002
- Last updated
- 16 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airway Responses Following Chlorine Gas Exposure
- ClinicalTrials.gov ID
- NCT00037427
- Acronym / sponsor ID
- 1170
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Sep 2001
- Study completion
- Jul 2004 (actual)
- First posted
- 17 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
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 design
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colin Solomon
University of California at San Francisco
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.