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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

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.

  1. First posted26 May 2000 (estimated)
  2. Study startJun 1971
  3. Study completionNov 1997

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
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 4813828
  • Lebowitz MD, Burrows B. Air pollution and respiratory illness. Ariz Med. 1973 Aug;38(8):543-7. No abstract available.

    PubMed 4581576
  • Knudson 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 4573465
  • Nelson 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 4723041
  • Morse 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 1078596
  • Diener 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 1137239
  • Burrows 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 1155443
  • Lebowitz 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 1155444
  • Lebowitz 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 868858
  • Lebowitz 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 1078974
  • Burrows 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 1163892
  • Lebowitz 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 1244287
  • Lebowitz M: Aerosol Usage and Respiratory Symptomatology. Arch Environ Health. (Presented at Food and Drug Administration Hearings, Washington, D.C, Dec. 16-18, 1974

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.

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