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Airways Dysfunction Following WTC Dust Exposure

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ClinicalTrials.gov Identifier: NCT00395330
Recruitment Status : Completed
First Posted : November 2, 2006
Last Update Posted : August 20, 2015
Sponsor:
Information provided by:
NYU Langone Health

Tracking Information
First Submitted Date November 1, 2006
First Posted Date November 2, 2006
Last Update Posted Date August 20, 2015
Study Start Date April 2003
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00395330 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Airways Dysfunction Following WTC Dust Exposure
Official Title Airways Dysfunction Following WTC Dust Exposure
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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.
Condition Pulmonary Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
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. Epub 2007 Sep 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: November¬†1,¬†2006)
500
Original Enrollment Same as current
Actual Study Completion Date October 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • inability to perform testing
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00395330
Other Study ID Numbers H06-714
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor NYU Langone Health
Collaborators Not Provided
Investigators
Principal Investigator: Kenneth I Berger, MD NYU Langone Health
PRS Account NYU Langone Health
Verification Date August 2015