NCT00395330

Brief 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 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2003

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2006

Completed
Last Updated

August 20, 2015

Status Verified

August 1, 2015

Enrollment Period

3.5 years

First QC Date

November 1, 2006

Last Update Submit

August 19, 2015

Conditions

Keywords

Respiratory Function TestsOscillometryWorld Trade Center DisasterEnvironmental ExposureDistal Airways

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • age 18-80
  • referral for pulmonary function evaluation of respiratory symptoms following exposure to WTC dust

You may not qualify if:

  • inability to perform testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Kenneth I Berger, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 2006

First Posted

November 2, 2006

Study Start

April 1, 2003

Primary Completion

October 1, 2006

Study Completion

October 1, 2006

Last Updated

August 20, 2015

Record last verified: 2015-08