AsthmaNCT00005283
Risk Factors For Asthma in Laboratory Animal Allergy
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To identify risk factors which predispose individuals to develop asthma and other manifestations of allergic disease on exposure to laboratory animals in the workplace. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Asthma, Lung Diseases
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1983to Jun 1990
- 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 Up to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To identify risk factors which predispose individuals to develop asthma and other manifestations of allergic disease on exposure to laboratory animals in the workplace.
Read the detailed description
BACKGROUND:
In 1982, asthma and allergy to laboratory animals among persons who worked with the animals gained increased recognition as an occupational health problem affecting researchers, veterinarians, technicians, animal handlers, and others. At that time, more than 90,000 workers across the United States were at risk due to their exposure to lab animals in the more than 1,100 facilities registered by the United States Department of Agriculture. Several surveys of exposed workers indicated a prevalence rate of allergic symptoms due to laboratory animal allergy ranging from 19-30 percent in animal workers. Asthma was also a frequent disease among animal workers; these surveys indicated that as many as 13-14 percent of exposed workers had asthma.
The problem of laboratory animal allergy and asthma involved a vast industry that included medical and veterinary colleges, research institutes and universities, pharmaceutical manufacturers, commercial laboratory animal producers, and hospitals.
DESIGN NARRATIVE:
Recruitment for this longitudinal study began in November 1983 and ended in July 1987. The initial visit consisted of an extensive interview to identify and to exclude those individuals with laboratory animal allergy, asthma, and other manifestations of allergy and to obtain an occupational history. Venipuncture was used to obtain serum for IgE and IgG antibody assays. Pulmonary function tests, including a methacholine challenge, were administered. Psychosocial questionnaires were administered. Subjects were evaluated at six month intervals with skin tests, venipuncture, and methacholine challenge. The degree of exposure to animal allergens was quantitated by aeroallergen sampling of workplace and personal breathing zone air and by work diaries.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
- Conditions
- Asthma, Lung Diseases
- Medical subject headings
- Asthma, Lung Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1983
- Study completionJun 1990
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The 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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005283
- Sponsor's protocol ID
- 2004
- Other IDs
- R01HL030532
- Status last verified
- May 2000
- First submitted
- 25 May 2000
- Last updated
- 18 Feb 2016
- Results posted
- No
Publications
Corn M, Koegel A, Hall T, Scott A, Newill C, Evans R: Characteristics of Airborne Particles Associated with Animal Allergy in Laboratory Workers. Ann Occup Hyg, 32:435-446 (Suppl 1), 1988
Evans R III, Summers RJ, Newill CA: Allergic Reactions Caused by Exposure to Animals. In: Lichtenstein LM, Fauci AS (Eds), Current Therapy in Allergy, Immunology and Rheumatology - III. BC Decker Inc, Toronto, Philadelphia, p 5-7, 1988
Eggleston PA, Newill CA, Ansari AA, Pustelnik A, Lou SR, Evans R 3rd, Marsh DG, Longbottom JL, Corn M. Task-related variation in airborne concentrations of laboratory animal allergens: studies with Rat n I. J Allergy Clin Immunol. 1989 Sep;84(3):347-52. doi: 10.1016/0091-6749(89)90419-3.
PubMed 2778241Eggleston PA, Kagey-Sobotka A, Proud D, Adkinson NF Jr, Lichtenstein LM. Disassociation of the release of histamine and arachidonic acid metabolites from osmotically activated basophils and human lung mast cells. Am Rev Respir Dis. 1990 Apr;141(4 Pt 1):960-4. doi: 10.1164/ajrccm/141.4_Pt_1.960.
PubMed 1691604Eggleston PA, Ansari AA, Ziemann B, Adkinson NF Jr, Corn M. Occupational challenge studies with laboratory workers allergic to rats. J Allergy Clin Immunol. 1990 Jul;86(1):63-72. doi: 10.1016/s0091-6749(05)80124-1.
PubMed 2196304Evans R III, Fortney S, Menkes H, Newill C, Cohens BH: Biological Indicators of Susceptibility. In: Green GM, Baker F (Eds), Work, Health and Productivity. Oxford University Press, 1991.
Newill CA, Prenger VL, Fish JE, Evans R 3rd, Diamond EL, Wei Q, Eggleston PA. Risk factors for increased airway responsiveness to methacholine challenge among laboratory animal workers. Am Rev Respir Dis. 1992 Dec;146(6):1494-500. doi: 10.1164/ajrccm/146.6.1494.
PubMed 1456566Ziemann B, Corn M, Ansari AA, Eggleston P. The effectiveness of the Duo-Flo BioClean unit for controlling airborne antigen levels. Am Ind Hyg Assoc J. 1992 Feb;53(2):138-45. doi: 10.1080/15298669291359401.
PubMed 1543130Newill CA, Eggleston PA, Prenger VL, Fish JE, Diamond EL, Wei Q, Evans R 3rd. Prospective study of occupational asthma to laboratory animal allergens: stability of airway responsiveness to methacholine challenge for one year. J Allergy Clin Immunol. 1995 Mar;95(3):707-15. doi: 10.1016/s0091-6749(95)70176-1.
PubMed 7897154Eggleston PA, Ansari AA, Adkinson NF Jr, Wood RA. Environmental challenge studies in laboratory animal allergy. Effect of different airborne allergen concentrations. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 1):640-6. doi: 10.1164/ajrccm.151.3.7881650.
PubMed 7881650
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors For Asthma in Laboratory Animal Allergy
- ClinicalTrials.gov ID
- NCT00005283
- Acronym / sponsor ID
- 2004
- Conditions
- Asthma, Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1983
- Study completion
- Jun 1990 (actual)
- First posted
- 26 May 2000 (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 identify risk factors which predispose individuals to develop asthma and other manifestations of allergic disease on exposure to laboratory animals in the workplace.
Detailed description
BACKGROUND:
In 1982, asthma and allergy to laboratory animals among persons who worked with the animals gained increased recognition as an occupational health problem affecting researchers, veterinarians, technicians, animal handlers, and others. At that time, more than 90,000 workers across the United States were at risk due to their exposure to lab animals in the more than 1,100 facilities registered by the United States Department of Agriculture. Several surveys of exposed workers indicated a prevalence rate of allergic symptoms due to laboratory animal allergy ranging from 19-30 percent in animal workers. Asthma was also a frequent disease among animal workers; these surveys indicated that as many as 13-14 percent of exposed workers had asthma.
The problem of laboratory animal allergy and asthma involved a vast industry that included medical and veterinary colleges, research institutes and universities, pharmaceutical manufacturers, commercial laboratory animal producers, and hospitals.
DESIGN NARRATIVE:
Recruitment for this longitudinal study began in November 1983 and ended in July 1987. The initial visit consisted of an extensive interview to identify and to exclude those individuals with laboratory animal allergy, asthma, and other manifestations of allergy and to obtain an occupational history. Venipuncture was used to obtain serum for IgE and IgG antibody assays. Pulmonary function tests, including a methacholine challenge, were administered. Psychosocial questionnaires were administered. Subjects were evaluated at six month intervals with skin tests, venipuncture, and methacholine challenge. The degree of exposure to animal allergens was quantitated by aeroallergen sampling of workplace and personal breathing zone air and by work diaries.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study design
Who may qualify
- Ages
- Up to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 Feb 2016.
- BackgroundCorn M, Koegel A, Hall T, Scott A, Newill C, Evans R: Characteristics of Airborne Particles Associated with Animal Allergy in Laboratory Workers. Ann Occup Hyg, 32:435-446 (Suppl 1), 1988
- BackgroundEvans R III, Summers RJ, Newill CA: Allergic Reactions Caused by Exposure to Animals. In: Lichtenstein LM, Fauci AS (Eds), Current Therapy in Allergy, Immunology and Rheumatology - III. BC Decker Inc, Toronto, Philadelphia, p 5-7, 1988
- Background: PubMed 2778241Eggleston PA, Newill CA, Ansari AA, Pustelnik A, Lou SR, Evans R 3rd, Marsh DG, Longbottom JL, Corn M. Task-related variation in airborne concentrations of laboratory animal allergens: studies with Rat n I. J Allergy Clin Immunol. 1989 Sep;84(3):347-52. doi: 10.1016/0091-6749(89)90419-3.
- Background: PubMed 1691604Eggleston PA, Kagey-Sobotka A, Proud D, Adkinson NF Jr, Lichtenstein LM. Disassociation of the release of histamine and arachidonic acid metabolites from osmotically activated basophils and human lung mast cells. Am Rev Respir Dis. 1990 Apr;141(4 Pt 1):960-4. doi: 10.1164/ajrccm/141.4_Pt_1.960.
- Background: PubMed 2196304Eggleston PA, Ansari AA, Ziemann B, Adkinson NF Jr, Corn M. Occupational challenge studies with laboratory workers allergic to rats. J Allergy Clin Immunol. 1990 Jul;86(1):63-72. doi: 10.1016/s0091-6749(05)80124-1.
- BackgroundEvans R III, Fortney S, Menkes H, Newill C, Cohens BH: Biological Indicators of Susceptibility. In: Green GM, Baker F (Eds), Work, Health and Productivity. Oxford University Press, 1991.
- Background: PubMed 1456566Newill CA, Prenger VL, Fish JE, Evans R 3rd, Diamond EL, Wei Q, Eggleston PA. Risk factors for increased airway responsiveness to methacholine challenge among laboratory animal workers. Am Rev Respir Dis. 1992 Dec;146(6):1494-500. doi: 10.1164/ajrccm/146.6.1494.
- Background: PubMed 1543130Ziemann B, Corn M, Ansari AA, Eggleston P. The effectiveness of the Duo-Flo BioClean unit for controlling airborne antigen levels. Am Ind Hyg Assoc J. 1992 Feb;53(2):138-45. doi: 10.1080/15298669291359401.
- Background: PubMed 7897154Newill CA, Eggleston PA, Prenger VL, Fish JE, Diamond EL, Wei Q, Evans R 3rd. Prospective study of occupational asthma to laboratory animal allergens: stability of airway responsiveness to methacholine challenge for one year. J Allergy Clin Immunol. 1995 Mar;95(3):707-15. doi: 10.1016/s0091-6749(95)70176-1.
- Background: PubMed 7881650Eggleston PA, Ansari AA, Adkinson NF Jr, Wood RA. Environmental challenge studies in laboratory animal allergy. Effect of different airborne allergen concentrations. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 1):640-6. doi: 10.1164/ajrccm.151.3.7881650.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Feb 2016. 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 NCT00005283, which also lists 10 linked publications.
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 Feb 2016.