AsthmaNCT00005564
Impact of Adult Asthma
An observational study of Asthma and Lung Diseases, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To assess the separate and interactive effects of asthma severity, subspecialty practice variation, asthma-related psychosocial variables, and other factors on asthma outcomes, including asthma-specific quality of life and activity limitations, health care utilization for asthma, and direct and indirect costs of… 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 1997to Jun 2002
- 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 assess the separate and interactive effects of asthma severity, subspecialty practice variation, asthma-related psychosocial variables, and other factors on asthma outcomes, including asthma-specific quality of life and activity limitations, health care utilization for asthma, and direct and indirect costs of asthma.
Read the detailed description
BACKGROUND:
Asthma is both common and costly. Neither the risk factors of poor outcome nor the predictors of better outcome are well understood. Illness severity is clearly an important predictive factor in asthma, but may explain less variability in outcome than other determinants, such as patient-perceived asthma control, other asthma-related psychosocial measures, and the kind and extent of subspecialty care for asthma. By quantifying predictors of asthma-specific quality of life, functional status, services utilization, and the direct and indirect illness costs of asthma, this study addressed a major research gap in secondary and tertiary prevention efforts.
DESIGN NARRATIVE:
A random sample of pulmonary and allergy subspecialists initially enrolled 600 persons with asthma identified in patient visit logs. This established panel completed 45 minute baseline and follow-up computer-assisted telephone interviews (CATI); 539 (90%) were successfully re-interviewed after 18 months of follow-up. A supplemental sampling frame of persons with asthma identified from family practitioners was completed as was a group with rhinitis but without asthma. Interviews assessed disease severity and other covariables using validated survey instruments. Pulmonary function and medical records were used to validate severity in a sub-sample of subjects. The study extended longitudinal follow-up study of this initial cohort. Its analysis tested predictive models for the asthma outcomes of interest.
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 1997
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)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
- Investigators
- Paul Blanc, University of California at San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005564
- Sponsor's protocol ID
- 5113
- Other IDs
- R01HL056438
- Status last verified
- Jul 2004
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Katz PP, Eisner MD, Henke J, Shiboski S, Yelin EH, Blanc PD. The Marks Asthma Quality of Life Questionnaire: further validation and examination of responsiveness to change. J Clin Epidemiol. 1999 Jul;52(7):667-75. doi: 10.1016/s0895-4356(99)00026-8.
PubMed 10391660Yelin E, Henke J, Katz PP, Eisner MD, Blanc PD. Work dynamics of adults with asthma. Am J Ind Med. 1999 May;35(5):472-80. doi: 10.1002/(sici)1097-0274(199905)35:53.0.co;2-s.
PubMed 10212700Eisner MD, Katz PP, Yelin EH, Henke J, Smith S, Blanc PD. Assessment of asthma severity in adults with asthma treated by family practitioners, allergists, and pulmonologists. Med Care. 1998 Nov;36(11):1567-77. doi: 10.1097/00005650-199811000-00006.
PubMed 9821944Eisner MD, Yelin EH, Henke J, Shiboski SC, Blanc PD. Environmental tobacco smoke and adult asthma. The impact of changing exposure status on health outcomes. Am J Respir Crit Care Med. 1998 Jul;158(1):170-5. doi: 10.1164/ajrccm.158.1.9801028.
PubMed 9655725Eisner MD, Yelin EH, Katz PP, Shiboski SC, Henke J, Blanc PD. Predictors of cigarette smoking and smoking cessation among adults with asthma. Am J Public Health. 2000 Aug;90(8):1307-11. doi: 10.2105/ajph.90.8.1307.
PubMed 10937016Yelin E, Trupin L, Cisternas M, Eisner M, Katz P, Blanc P. A national study of medical care expenditures for respiratory conditions. Eur Respir J. 2002 Mar;19(3):414-21. doi: 10.1183/09031936.02.00522001.
PubMed 11936516Blanc PD, Trupin L, Earnest G, Katz PP, Yelin EH, Eisner MD. Alternative therapies among adults with a reported diagnosis of asthma or rhinosinusitis : data from a population-based survey. Chest. 2001 Nov;120(5):1461-7. doi: 10.1378/chest.120.5.1461.
PubMed 11713120Eisner MD, Katz PP, Yelin EH, Shiboski SC, Blanc PD. Risk factors for hospitalization among adults with asthma: the influence of sociodemographic factors and asthma severity. Respir Res. 2001;2(1):53-60. doi: 10.1186/rr37. Epub 2000 Dec 29.
PubMed 11686864Eisner MD, Katz PP, Yelin EH, Hammond SK, Blanc PD. Measurement of environmental tobacco smoke exposure among adults with asthma. Environ Health Perspect. 2001 Aug;109(8):809-14. doi: 10.1289/ehp.01109809.
PubMed 11564616Blanc PD, Trupin L, Eisner M, Earnest G, Katz PP, Israel L, Yelin EH. The work impact of asthma and rhinitis: findings from a population-based survey. J Clin Epidemiol. 2001 Jun;54(6):610-8. doi: 10.1016/s0895-4356(00)00349-8.
PubMed 11377122Katz PP, Yelin EH, Eisner MD, Blanc PD. Perceived control of asthma and quality of life among adults with asthma. Ann Allergy Asthma Immunol. 2002 Sep;89(3):251-8. doi: 10.1016/S1081-1206(10)61951-5.
PubMed 12269644Eisner MD, Yelin EH, Katz PP, Earnest G, Blanc PD. Exposure to indoor combustion and adult asthma outcomes: environmental tobacco smoke, gas stoves, and woodsmoke. Thorax. 2002 Nov;57(11):973-8. doi: 10.1136/thorax.57.11.973.
PubMed 12403881Eisner MD, Blanc PD. Environmental tobacco smoke exposure during travel among adults with asthma. Chest. 2002 Sep;122(3):826-8. doi: 10.1378/chest.122.3.826.
PubMed 12226020Blanc PD, Trupin L, Earnest G, San Pedro M, Katz PP, Yelin EH, Eisner MD. Effects of physician-related factors on adult asthma care, health status, and quality of life. Am J Med. 2003 May;114(7):581-7. doi: 10.1016/s0002-9343(03)00053-6.
PubMed 12753882Cisternas MG, Blanc PD, Yen IH, Katz PP, Earnest G, Eisner MD, Shiboski S, Yelin EH. A comprehensive study of the direct and indirect costs of adult asthma. J Allergy Clin Immunol. 2003 Jun;111(6):1212-8. doi: 10.1067/mai.2003.1449.
PubMed 12789219
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adult Asthma
- ClinicalTrials.gov ID
- NCT00005564
- Acronym / sponsor ID
- 5113
- 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 1997
- Study completion
- Jun 2002 (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 assess the separate and interactive effects of asthma severity, subspecialty practice variation, asthma-related psychosocial variables, and other factors on asthma outcomes, including asthma-specific quality of life and activity limitations, health care utilization for asthma, and direct and indirect costs of asthma.
Detailed description
BACKGROUND:
Asthma is both common and costly. Neither the risk factors of poor outcome nor the predictors of better outcome are well understood. Illness severity is clearly an important predictive factor in asthma, but may explain less variability in outcome than other determinants, such as patient-perceived asthma control, other asthma-related psychosocial measures, and the kind and extent of subspecialty care for asthma. By quantifying predictors of asthma-specific quality of life, functional status, services utilization, and the direct and indirect illness costs of asthma, this study addressed a major research gap in secondary and tertiary prevention efforts.
DESIGN NARRATIVE:
A random sample of pulmonary and allergy subspecialists initially enrolled 600 persons with asthma identified in patient visit logs. This established panel completed 45 minute baseline and follow-up computer-assisted telephone interviews (CATI); 539 (90%) were successfully re-interviewed after 18 months of follow-up. A supplemental sampling frame of persons with asthma identified from family practitioners was completed as was a group with rhinitis but without asthma. Interviews assessed disease severity and other covariables using validated survey instruments. Pulmonary function and medical records were used to validate severity in a sub-sample of subjects. The study extended longitudinal follow-up study of this initial cohort. Its analysis tested predictive models for the asthma outcomes of interest.
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 16 Mar 2016.
- Background: PubMed 10391660Katz PP, Eisner MD, Henke J, Shiboski S, Yelin EH, Blanc PD. The Marks Asthma Quality of Life Questionnaire: further validation and examination of responsiveness to change. J Clin Epidemiol. 1999 Jul;52(7):667-75. doi: 10.1016/s0895-4356(99)00026-8.
- Background: PubMed 10212700Yelin E, Henke J, Katz PP, Eisner MD, Blanc PD. Work dynamics of adults with asthma. Am J Ind Med. 1999 May;35(5):472-80. doi: 10.1002/(sici)1097-0274(199905)35:53.0.co;2-s.
- Background: PubMed 9821944Eisner MD, Katz PP, Yelin EH, Henke J, Smith S, Blanc PD. Assessment of asthma severity in adults with asthma treated by family practitioners, allergists, and pulmonologists. Med Care. 1998 Nov;36(11):1567-77. doi: 10.1097/00005650-199811000-00006.
- Background: PubMed 9655725Eisner MD, Yelin EH, Henke J, Shiboski SC, Blanc PD. Environmental tobacco smoke and adult asthma. The impact of changing exposure status on health outcomes. Am J Respir Crit Care Med. 1998 Jul;158(1):170-5. doi: 10.1164/ajrccm.158.1.9801028.
- Background: PubMed 10937016Eisner MD, Yelin EH, Katz PP, Shiboski SC, Henke J, Blanc PD. Predictors of cigarette smoking and smoking cessation among adults with asthma. Am J Public Health. 2000 Aug;90(8):1307-11. doi: 10.2105/ajph.90.8.1307.
- Background: PubMed 11936516Yelin E, Trupin L, Cisternas M, Eisner M, Katz P, Blanc P. A national study of medical care expenditures for respiratory conditions. Eur Respir J. 2002 Mar;19(3):414-21. doi: 10.1183/09031936.02.00522001.
- Background: PubMed 11713120Blanc PD, Trupin L, Earnest G, Katz PP, Yelin EH, Eisner MD. Alternative therapies among adults with a reported diagnosis of asthma or rhinosinusitis : data from a population-based survey. Chest. 2001 Nov;120(5):1461-7. doi: 10.1378/chest.120.5.1461.
- Background: PubMed 11686864Eisner MD, Katz PP, Yelin EH, Shiboski SC, Blanc PD. Risk factors for hospitalization among adults with asthma: the influence of sociodemographic factors and asthma severity. Respir Res. 2001;2(1):53-60. doi: 10.1186/rr37. Epub 2000 Dec 29.
- Background: PubMed 11564616Eisner MD, Katz PP, Yelin EH, Hammond SK, Blanc PD. Measurement of environmental tobacco smoke exposure among adults with asthma. Environ Health Perspect. 2001 Aug;109(8):809-14. doi: 10.1289/ehp.01109809.
- Background: PubMed 11377122Blanc PD, Trupin L, Eisner M, Earnest G, Katz PP, Israel L, Yelin EH. The work impact of asthma and rhinitis: findings from a population-based survey. J Clin Epidemiol. 2001 Jun;54(6):610-8. doi: 10.1016/s0895-4356(00)00349-8.
- Background: PubMed 12269644Katz PP, Yelin EH, Eisner MD, Blanc PD. Perceived control of asthma and quality of life among adults with asthma. Ann Allergy Asthma Immunol. 2002 Sep;89(3):251-8. doi: 10.1016/S1081-1206(10)61951-5.
- Background: PubMed 12403881Eisner MD, Yelin EH, Katz PP, Earnest G, Blanc PD. Exposure to indoor combustion and adult asthma outcomes: environmental tobacco smoke, gas stoves, and woodsmoke. Thorax. 2002 Nov;57(11):973-8. doi: 10.1136/thorax.57.11.973.
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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.
Paul Blanc
University of California at San Francisco
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 16 Mar 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 NCT00005564, which also lists 16 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 16 Mar 2016.