AsthmaNCT00014820
Occupation and Asthma in an Urban Low Income Population
An observational study of Asthma and Lung Diseases, run by NYU Langone Health.
Trial summary
To study work-related asthma in a low-income, urban population. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- Mar 2001to Feb 2005
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients at Bellevue Hospital who were given a diagnosis between the dates of 1/1/1996 and 6/30/2003.
Who may be able to join
None listed.
Who cannot join
- Subject unwilling to be interviewed or does not give informed consent
- For nonsmokers, age under 18 or over 65. For smokers, age under 18 or over 45
- For cases, asthma diagnosis (at Bellevue or elsewhere) prior to beginning of study period. For controls, asthma diagnosis ever.
- Unemployed at case onset age
- Fee-coded as Medicaid for all visits during study period
- Fluency in either English or Spanish inadequate to communicate clearly with interviewer, or need for interpreter in language other than Spanish noted in chart
Show all 10Show fewer
- Medical records not HIV disease, STD, addiction-related diagnosis, or other "sensitive" diagnosis (to avoid problems of confidentiality)
- Clear understanding of what is being asked is lacking, in judgement of interviewer
- Responses to initial interview questions appear grossly unreliable, in the judgement of the interviewer
- Prisoners
About this study
To study work-related asthma in a low-income, urban population.
Read the detailed 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.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a diagnosis of asthma (new) (Cases) | Patients with a physician diagnosis of asthma during the 7.5 years being studied who were working at the time of diagnosis, as determined by patient interviews. | |
| Patients with a diagnosis other than asthma (Controls) | Patients (age-matched to a case patient) with a physician diagnosis other than asthma who were working at the time of diagnosis. | |
| Patients with a diagnosis of asthma (previous) | Patients with a physician diagnosis of asthma prior to the 7.5 years being studied |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2001 (estimated)
- Study startMar 2001
- Primary completionFeb 2005
- Study completionFeb 2005
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 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- George Friedman-Jimenez, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00014820
- Sponsor's protocol ID
- 7953
- Other IDs
- R01HL062621
- Status last verified
- Dec 2015
- First submitted
- 11 Apr 2001
- Last updated
- 18 Dec 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupation and Asthma in an Urban Low Income Population
- ClinicalTrials.gov ID
- NCT00014820
- Acronym / sponsor ID
- 7953
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2001
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 12 Apr 2001 (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 study work-related asthma in a low-income, urban population.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with a diagnosis of asthma (new) (Cases) | – | –Patients with a physician diagnosis of asthma during the 7.5 years being studied who were working at the time of diagnosis, as determined by patient interviews. |
| Patients with a diagnosis other than asthma (Controls) | – | –Patients (age-matched to a case patient) with a physician diagnosis other than asthma who were working at the time of diagnosis. |
| Patients with a diagnosis of asthma (previous) | – | –Patients with a physician diagnosis of asthma prior to the 7.5 years being studied |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at Bellevue Hospital who were given a diagnosis between the dates of 1/1/1996 and 6/30/2003.
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Subject unwilling to be interviewed or does not give informed consent
- For nonsmokers, age under 18 or over 65. For smokers, age under 18 or over 45
- For cases, asthma diagnosis (at Bellevue or elsewhere) prior to beginning of study period. For controls, asthma diagnosis ever.
- Unemployed at case onset age
- Fee-coded as Medicaid for all visits during study period
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 18 Dec 2015.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
George Friedman-Jimenez principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung 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 0 inclusion and 10 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 18 Dec 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?
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 18 Dec 2015.