Pulmonary DiseasesNCT00395330
Airways Dysfunction Following WTC Dust Exposure
An observational study of Pulmonary Diseases, run by NYU Langone Health.
Trial summary
In the weeks following the terrorist attacks of September 11, 2001, many patients presented to their physicians with complaints related to exposure to the debris. These included nose and throat complaints (drip, congestion, sore throat), increased GE reflux (heartburn, regurgitation, retrosternal chest burning) and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Diseases
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Apr 2003to Oct 2006
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: study will retrospectively review the charts of all patients referred to the pulmonary function laboratory for evaluation of symptoms following exposure to WTC dust.
Who may be able to join
- age 18-80
- referral for pulmonary function evaluation of respiratory symptoms following exposure to WTC dust
Who cannot join
- inability to perform testing
About this study
In the weeks following the terrorist attacks of September 11, 2001, many patients presented to their physicians with complaints related to exposure to the debris. These included nose and throat complaints (drip, congestion, sore throat), increased GE reflux (heartburn, regurgitation, retrosternal chest burning) and respiratory symptoms (worsening cough, wheezing, shortness of breath, chest tightness, sleep disturbance). In addition, there was a disproportionate rate of self-reported worsening asthma symptoms in patients living in Lower New York 5-9 weeks after the attack; those with exposure to the dust cloud fared worse. The functional abnormalities of firefighters with exposures to dust at the WTC site has been recently described. However, the effects of WTC dust exposure on pulmonary function in residents and workers near the WTC site remain unclear. This study will retrospectively review the charts of all patients referred to the pulmonary function laboratory for evaluation of symptoms following exposure to WTC dust. The main objectives for this study will be to characterize the functional abnormalities in these subjects.
- Conditions
- Pulmonary Diseases
- Keywords
- Respiratory Function Tests, Oscillometry, World Trade Center Disaster, Environmental Exposure, Distal Airways
- Medical subject headings
- Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2006 (estimated)
- Study startApr 2003
- Primary completionOct 2006
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary DiseasesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Investigators
- Kenneth I Berger, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00395330
- Sponsor's protocol ID
- H06-714
- Status last verified
- Aug 2015
- First submitted
- 1 Nov 2006
- Last updated
- 20 Aug 2015
- Results posted
- No
Publications
Oppenheimer BW, Goldring RM, Herberg ME, Hofer IS, Reyfman PA, Liautaud S, Rom WN, Reibman J, Berger KI. Distal airway function in symptomatic subjects with normal spirometry following World Trade Center dust exposure. Chest. 2007 Oct;132(4):1275-82. doi: 10.1378/chest.07-0913. Epub 2007 Sep 21.
PubMed 17890470
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Airways Dysfunction Following WTC Dust Exposure
- ClinicalTrials.gov ID
- NCT00395330
- Acronym / sponsor ID
- H06-714
- Conditions
- Pulmonary Diseases
- Keywords
- Respiratory Function Tests, Oscillometry, World Trade Center Disaster, Environmental Exposure, Distal Airways
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 2 Nov 2006 (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.
In the weeks following the terrorist attacks of September 11, 2001, many patients presented to their physicians with complaints related to exposure to the debris. These included nose and throat complaints (drip, congestion, sore throat), increased GE reflux (heartburn, regurgitation, retrosternal chest burning) and respiratory symptoms (worsening cough, wheezing, shortness of breath, chest tightness, sleep disturbance). In addition, there was a disproportionate rate of self-reported worsening asthma symptoms in patients living in Lower New York 5-9 weeks after the attack; those with exposure to the dust cloud fared worse. The functional abnormalities of firefighters with exposures to dust at the WTC site has been recently described. However, the effects of WTC dust exposure on pulmonary function in residents and workers near the WTC site remain unclear. This study will retrospectively review the charts of all patients referred to the pulmonary function laboratory for evaluation of symptoms following exposure to WTC dust. The main objectives for this study will be to characterize the functional abnormalities in these subjects.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- study will retrospectively review the charts of all patients referred to the pulmonary function laboratory for evaluation of symptoms following exposure to WTC dust.
Key inclusion criteria (2 listed)
- age 18-80
- referral for pulmonary function evaluation of respiratory symptoms following exposure to WTC dust
Key exclusion criteria (1 listed)
- inability to perform testing
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 20 Aug 2015.
- Derived from this study: PubMed 17890470Oppenheimer BW, Goldring RM, Herberg ME, Hofer IS, Reyfman PA, Liautaud S, Rom WN, Reibman J, Berger KI. Distal airway function in symptomatic subjects with normal spirometry following World Trade Center dust exposure. Chest. 2007 Oct;132(4):1275-82. doi: 10.1378/chest.07-0913. Epub 2007 Sep 21.
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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.
Kenneth I Berger, MD principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Diseases, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. 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 20 Aug 2015. 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?
On the ClinicalTrials.gov record for NCT00395330, which also lists 1 linked publication.
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 20 Aug 2015.