Occupation and Asthma in an Urban Low Income Population

Asthma Clinical Trial

Official title:

Occupation and Asthma in an Urban Low Income Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00014820
• Other study ID #: 7953
• Secondary ID: R01HL062621
• Status: Completed
• Phase: N/A
• First received: April 11, 2001
• Last updated: December 17, 2015
• Start date: March 2001
• Est. completion date: February 2005

Study information

• Verified date: December 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

To study work-related asthma in a low-income, urban population.

Description:

BACKGROUND:

Work-related asthma is asthma that is attributable to, or is made worse by, environmental exposures in the workplace. Published estimates of the proportion of adult asthma attributable to occupational factors have varied widely, depending on population, methodology, and definitions, from 2 percent to 33 percent. Occupational asthma is of great public health importance because it is potentially preventable, can cause substantial disability, and in some cases is completely curable. Among adults in the United States, asthma has become a major public health problem, with rates most elevated among low income, urban, African American and Latino sectors of the population, and with substantial evidence suggesting potential occupational contributions to the excess rates. These important sectors of the U.S. population have, however, been inadequately represented in the occupational asthma research literature.

DESIGN NARRATIVE:

This was a case control study of physician-diagnosed asthma, occupation, industry, and workplace environmental exposures designed to evaluate the hypothesis that a substantial component of the asthma burden in a low income, urban, largely minority population was due to occupational factors. The study design addressed a variety of methodologic challenges including healthy worker effects, difficulty contacting and recruiting this potentially high risk population, large numbers of potential etiologic agents, mixed exposures, small workplaces, and low absolute incidence of occupational asthma.

The study population was the catchment population of Bellevue Hospital, a general hospital in lower Manhattan, New York City, with busy ambulatory care services that serve low income working communities. Cases and controls were recruited from among outpatients and inpatients at Bellevue Hospital and interviewed face-to-face or by telephone. Occupation, industry, and occupational exposures were determined by questionnaire supplemented by a Job Exposure Matrix. Odds ratios (ORs) of association between asthma and specific industrial, occupational, and exposure categories, controlled for major confounders, were estimated. The ORs were used to calculate occupation- and industry-specific Attributable Fractions, and an overall Population Attributable Fraction of asthma attributable to occupational factors. New onset occupational asthma and work-aggravated asthma were investigated separately.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Exclusion criteria:

1. Subject unwilling to be interviewed or does not give informed consent

2. For nonsmokers, age under 18 or over 65. For smokers, age under 18 or over 45

3. For cases, asthma diagnosis (at Bellevue or elsewhere) prior to beginning of study period. For controls, asthma diagnosis ever.

4. Unemployed at case onset age

5. Fee-coded as Medicaid for all visits during study period

6. Fluency in either English or Spanish inadequate to communicate clearly with interviewer, or need for interpreter in language other than Spanish noted in chart

7. Medical records not HIV disease, STD, addiction-related diagnosis, or other "sensitive" diagnosis (to avoid problems of confidentiality)

8. Clear understanding of what is being asked is lacking, in judgement of interviewer

9. Responses to initial interview questions appear grossly unreliable, in the judgement of the interviewer

10. Prisoners

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Asthma
• Lung Diseases

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI)