AsthmaNCT00005279
Tucson Epidemiology Study of Chronic Obstructive Lung Diseases
An observational study of Asthma and Bronchitis, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine the natural history, etiology, and interrelationships of emphysema, chronic bronchitis, asthma, and related airways obstructive diseases. Also, to determine the relationship of acute lower respiratory tract illnesses in infants and children to the development of subsequent chronic lung disorders. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Asthma, Bronchitis, Emphysema
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jun 1971to Nov 1997
- 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 determine the natural history, etiology, and interrelationships of emphysema, chronic bronchitis, asthma, and related airways obstructive diseases. Also, to determine the relationship of acute lower respiratory tract illnesses in infants and children to the development of subsequent chronic lung disorders.
Read the detailed description
BACKGROUND:
The Tucson Epidemiology Study of Chronic Obstructive Lung Diseases had been supported by the Specialized Center of Research (SCOR) mechanism since 1971. The SCOR mechanism was instituted to advance basic knowledge and to generate the most effective techniques and methods of clinical management and prevention.
In 1970, the chronic obstructive lung diseases (COLD) of bronchitis, emphysema, and asthma were the tenth leading cause of death in the United States. At that time United States mortality from emphysema had been increasing at the rate of 20-25 percent per year. In 1969 the death rate for COLD as a whole was 15.6 per 100,000 and that rate was considered to be only about one-half of all those deaths in which COLD was either an underlying or an important contributory cause. By 1986 COLD had risen to be the fifth leading cause of death in the United States with a death rate of 31.3 per 100,000.
By 1972 many prevalence surveys had been conducted in the United States and abroad on specific subgroups of populations. At that time, most longitudinal studies were limited in the scope of examinations conducted, dealt with restricted age groups, and conducted few studies of familial concordance of diseases. The Tucson study was designed to include a wide age span, family units, and a variety of features relating to reversible or irreversible obstructive lung disease.
Studies have provided evidence relating acute lower respiratory tract illnesses in the first few years of life to the development of chronic lung disease in later life. Epidemiologic studies have demonstrated that geographic areas with high morbidity and mortality rates due to chronic obstructive lung disease among adults are also likely to show a high incidence of respiratory illness among children. A number of risk factors may be associated with lower respiratory tract illness in children. Some studies suggested that familial or genetic factors may predispose certain children to respiratory disorders early in life. Family size, viral and bacterial infections, allergic reaction, air pollution, gas stoves, formaldehyde, and passive smoking have all been implicated. Research was needed on the interrelationships of potential risk factors and lower respiratory tract infections in producing chronic respiratory disease.
DESIGN NARRATIVE:
The Tucson Study of Chronic Obstructive Lung Diseases was longitudinal in design. By 1986, nine surveys had been completed on 70 percent of the same population surveyed at baseline in 1972. Data collected in the surveys included basic standardized questionnaires and maximum expiratory flow volume (MEFV) curves using the same pneumotachograph equipment. Additional questionnaires were included on smoking, medical and occupational history, socio-economic characteristics, and height and weight measurements. Blood was sampled for studies of alpha-1-antitrypsin level. Several surveys included allergy skin testing, blood pressure, and anthropometric measurements. Studies of the 504 out-migrants continued since 1982. Twelve surveys were planned to insure a follow-up of at least 15 years on all adults.
Funding represented approximately 26 percent of the dollars of the Specialized Center of Research in Chronic Diseases of the Airways (P5OHL14136) used to support the Tucson Study.
Childrens' Respiratory Study of Tucson was also longitudinal in design and assessed the role of infectious, physiologic, immunologic, allergic, genetic, environmental, and familial factors in the development of acute and chronic lower respiratory tract illnesses in childhood. Enrollment of the study population and their families occurred between May 1980 and October 1984. Healthy infants were enrolled within a few days of birth, at which time baseline data were collected. Cord and 9-month bloods were evaluated for a number of immunologic tests. In the first few months of life, prior to any lower respiratory tract illnesses, a subset of the population underwent pulmonary function testing. During lower respiratory tract illness, specimens were obtained for viral, chlamydial, and mycoplasma cultures and tests. Environmental factors evaluated included passive smoking, number of siblings, overcrowding, and air pollution. Data collection was continued on the children and their family members over the years.
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, Bronchitis, Emphysema, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Asthma, Bronchitis, Emphysema, Lung Diseases, Obstructive, Pulmonary Disease, Chronic Obstructive
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 startJun 1971
- Study completionNov 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (330)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
- NCT00005279
- Sponsor's protocol ID
- 2000
- Other IDs
- P50HL014136
- Status last verified
- May 2002
- First submitted
- 25 May 2000
- Last updated
- 29 Feb 2016
- Results posted
- No
Publications
Burrows B (Ed): Chronic Respiratory Disease, Med Clin North Am, W.B. Saunders Co, May 1973
Burrows B. Editorial: Early detection of airways obstruction. Chest. 1974 Mar;65(3):239-40. doi: 10.1016/s0012-3692(15)36309-1. No abstract available.
PubMed 4813828Lebowitz MD, Burrows B. Air pollution and respiratory illness. Ariz Med. 1973 Aug;38(8):543-7. No abstract available.
PubMed 4581576Knudson RJ, Burrows B. Early detection of obstructive lung diseases. Med Clin North Am. 1973 May;57(3):681-90. doi: 10.1016/s0025-7125(16)32267-2. No abstract available.
PubMed 4573465Nelson DC, Burrows B, Knudson RJ. A device for recording flow and volume data in population surveys. J Appl Physiol. 1973 Aug;35(2):304-6. doi: 10.1152/jappl.1973.35.2.304. No abstract available.
PubMed 4723041Morse JO, Lebowitz MD, Knudson RJ, Burrows B. A community study of the relation of alpha1-antitrypsin levels to obstructive lung diseases. N Engl J Med. 1975 Feb 6;292(6):278-81. doi: 10.1056/NEJM197502062920602.
PubMed 1078596Diener CF, Burrows B. Further observations on the course and prognosis of chronic obstructive lung disease. Am Rev Respir Dis. 1975 Jun;111(6):719-24. doi: 10.1164/arrd.1975.111.6.719.
PubMed 1137239Burrows B: Prognosis of the Bronchial and Emphysematous Types. In: Chron Obstr Lung, Stuttgart: Schattauer, pp. 171-173, 1975
Lebowitz MD, Knudson RJ, Burrows B. Tucson epidemiologic study of obstructive lung diseases. I: Methodology and prevalence of disease. Am J Epidemiol. 1975 Aug;102(2):137-52. doi: 10.1093/oxfordjournals.aje.a112141.
PubMed 1155443Lebowitz MD, Burrows B. Tucson epidemiologic study of obstructive lung diseases. II: Effects of in-migration factors on the prevalence of obstructive lung diseases. Am J Epidemiol. 1975 Aug;102(2):153-63. doi: 10.1093/oxfordjournals.aje.a112142.
PubMed 1155444Lebowitz MD, Burrows B. The relationship of acute respiratory illness history to the prevalence and incidence of obstructive lung disorders. Am J Epidemiol. 1977 Jun;105(6):544-54. doi: 10.1093/oxfordjournals.aje.a112418.
PubMed 868858Lebowitz MD, Morse JO, Knudson RJ, Barbee R, Burrows B. Respiratory disorders in Tucson: preliminary observations. Ariz Med. 1975 Apr;32(4):329-31. No abstract available.
PubMed 1078974Burrows B, Lebowitz MD. Characteristics of chronic bronchitis in a warm, dry region. Am Rev Respir Dis. 1975 Sep;112(3):365-70. doi: 10.1164/arrd.1975.112.3.365.
PubMed 1163892Lebowitz MD, Burrows B. Respiratory symptoms related to smoking habits of family adults. Chest. 1976 Jan;69(1):48-50. doi: 10.1378/chest.69.1.48.
PubMed 1244287Lebowitz M: Aerosol Usage and Respiratory Symptomatology. Arch Environ Health. (Presented at Food and Drug Administration Hearings, Washington, D.C, Dec. 16-18, 1974
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tucson Epidemiology Study of Chronic Obstructive Lung Diseases
- ClinicalTrials.gov ID
- NCT00005279
- Acronym / sponsor ID
- 2000
- Conditions
- Asthma, Bronchitis, Emphysema, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jun 1971
- Study completion
- Nov 1997 (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 determine the natural history, etiology, and interrelationships of emphysema, chronic bronchitis, asthma, and related airways obstructive diseases. Also, to determine the relationship of acute lower respiratory tract illnesses in infants and children to the development of subsequent chronic lung disorders.
Detailed description
BACKGROUND:
The Tucson Epidemiology Study of Chronic Obstructive Lung Diseases had been supported by the Specialized Center of Research (SCOR) mechanism since 1971. The SCOR mechanism was instituted to advance basic knowledge and to generate the most effective techniques and methods of clinical management and prevention.
In 1970, the chronic obstructive lung diseases (COLD) of bronchitis, emphysema, and asthma were the tenth leading cause of death in the United States. At that time United States mortality from emphysema had been increasing at the rate of 20-25 percent per year. In 1969 the death rate for COLD as a whole was 15.6 per 100,000 and that rate was considered to be only about one-half of all those deaths in which COLD was either an underlying or an important contributory cause. By 1986 COLD had risen to be the fifth leading cause of death in the United States with a death rate of 31.3 per 100,000.
By 1972 many prevalence surveys had been conducted in the United States and abroad on specific subgroups of populations. At that time, most longitudinal studies were limited in the scope of examinations conducted, dealt with restricted age groups, and conducted few studies of familial concordance of diseases. The Tucson study was designed to include a wide age span, family units, and a variety of features relating to reversible or irreversible obstructive lung disease.
Studies have provided evidence relating acute lower respiratory tract illnesses in the first few years of life to the development of chronic lung disease in later life. Epidemiologic studies have demonstrated that geographic areas with high morbidity and mortality rates due to chronic obstructive lung disease among adults are also likely to show a high incidence of respiratory illness among children. A number of risk factors may be associated with lower respiratory tract illness in children. Some studies suggested that familial or genetic factors may predispose certain children to respiratory disorders early in life. Family size, viral and bacterial infections, allergic reaction, air pollution, gas stoves, formaldehyde, and passive smoking have all been implicated. Research was needed on the interrelationships of potential risk factors and lower respiratory tract infections in producing chronic respiratory disease.
DESIGN NARRATIVE:
The Tucson Study of Chronic Obstructive Lung Diseases was longitudinal in design. By 1986, nine surveys had been completed on 70 percent of the same population surveyed at baseline in 1972. Data collected in the surveys included basic standardized questionnaires and maximum expiratory flow volume (MEFV) curves using the same pneumotachograph equipment. Additional questionnaires were included on smoking, medical and occupational history, socio-economic characteristics, and height and weight measurements. Blood was sampled for studies of alpha-1-antitrypsin level. Several surveys included allergy skin testing, blood pressure, and anthropometric measurements. Studies of the 504 out-migrants continued since 1982. Twelve surveys were planned to insure a follow-up of at least 15 years on all adults.
Funding represented approximately 26 percent of the dollars of the Specialized Center of Research in Chronic Diseases of the Airways (P5OHL14136) used to support the Tucson Study.
Childrens' Respiratory Study of Tucson was also longitudinal in design and assessed the role of infectious, physiologic, immunologic, allergic, genetic, environmental, and familial factors in the development of acute and chronic lower respiratory tract illnesses in childhood. Enrollment of the study population and their families occurred between May 1980 and October 1984. Healthy infants were enrolled within a few days of birth, at which time baseline data were collected. Cord and 9-month bloods were evaluated for a number of immunologic tests. In the first few months of life, prior to any lower respiratory tract illnesses, a subset of the population underwent pulmonary function testing. During lower respiratory tract illness, specimens were obtained for viral, chlamydial, and mycoplasma cultures and tests. Environmental factors evaluated included passive smoking, number of siblings, overcrowding, and air pollution. Data collection was continued on the children and their family members over the years.
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 29 Feb 2016.
- BackgroundBurrows B (Ed): Chronic Respiratory Disease, Med Clin North Am, W.B. Saunders Co, May 1973
- Background: PubMed 4813828Burrows B. Editorial: Early detection of airways obstruction. Chest. 1974 Mar;65(3):239-40. doi: 10.1016/s0012-3692(15)36309-1. No abstract available.
- Background: PubMed 4581576Lebowitz MD, Burrows B. Air pollution and respiratory illness. Ariz Med. 1973 Aug;38(8):543-7. No abstract available.
- Background: PubMed 4573465Knudson RJ, Burrows B. Early detection of obstructive lung diseases. Med Clin North Am. 1973 May;57(3):681-90. doi: 10.1016/s0025-7125(16)32267-2. No abstract available.
- Background: PubMed 4723041Nelson DC, Burrows B, Knudson RJ. A device for recording flow and volume data in population surveys. J Appl Physiol. 1973 Aug;35(2):304-6. doi: 10.1152/jappl.1973.35.2.304. No abstract available.
- Background: PubMed 1078596Morse JO, Lebowitz MD, Knudson RJ, Burrows B. A community study of the relation of alpha1-antitrypsin levels to obstructive lung diseases. N Engl J Med. 1975 Feb 6;292(6):278-81. doi: 10.1056/NEJM197502062920602.
- Background: PubMed 1137239Diener CF, Burrows B. Further observations on the course and prognosis of chronic obstructive lung disease. Am Rev Respir Dis. 1975 Jun;111(6):719-24. doi: 10.1164/arrd.1975.111.6.719.
- BackgroundBurrows B: Prognosis of the Bronchial and Emphysematous Types. In: Chron Obstr Lung, Stuttgart: Schattauer, pp. 171-173, 1975
- Background: PubMed 1155443Lebowitz MD, Knudson RJ, Burrows B. Tucson epidemiologic study of obstructive lung diseases. I: Methodology and prevalence of disease. Am J Epidemiol. 1975 Aug;102(2):137-52. doi: 10.1093/oxfordjournals.aje.a112141.
- Background: PubMed 1155444Lebowitz MD, Burrows B. Tucson epidemiologic study of obstructive lung diseases. II: Effects of in-migration factors on the prevalence of obstructive lung diseases. Am J Epidemiol. 1975 Aug;102(2):153-63. doi: 10.1093/oxfordjournals.aje.a112142.
- Background: PubMed 868858Lebowitz MD, Burrows B. The relationship of acute respiratory illness history to the prevalence and incidence of obstructive lung disorders. Am J Epidemiol. 1977 Jun;105(6):544-54. doi: 10.1093/oxfordjournals.aje.a112418.
- Background: PubMed 1078974Lebowitz MD, Morse JO, Knudson RJ, Barbee R, Burrows B. Respiratory disorders in Tucson: preliminary observations. Ariz Med. 1975 Apr;32(4):329-31. No abstract available.
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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 Bronchitis, 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 29 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 NCT00005279, which also lists 330 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 29 Feb 2016.