AzTrials
AzTrials

Lung DiseasesNCT00005282

Prospective Evaluation of Airways Reactivity

An observational study of Lung Diseases and Asthma, 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

From 1981 to 1991, to characterize the role of allergy and airways responsiveness in modifying growth of lung function in children and young adults in a community-based random population, the Childhood Respiratory Study in East Boston. Read more about this study

Who is it for?
Ages Up to 100 years, men only
Conditions the study is for
Lung Diseases, Asthma, Lung Diseases, Obstructive
How many people
Not given
Where
No sites listed yet
Study dates
Dec 1981to 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

From 1981 to 1991, to characterize the role of allergy and airways responsiveness in modifying growth of lung function in children and young adults in a community-based random population, the Childhood Respiratory Study in East Boston. From 1992 to 1997, to examine the relationship of respiratory symptoms and illnesses, cigarette smoking, airways responsiveness, and markers of inflammation to growth and decline in lung function in two well-characterized and investigated community-based populations of children and adults, the Childhood Respiratory Study in East Boston and the Normative Aging Study.

Read the detailed description

BACKGROUND:

Epidemiologic models for growth and decline in lung function have been developed from longitudinal studies in adults. The development of chronic obstructive lung disease appeared to be the result of both an abnormally rapid rate of decline in level of lung function in early adult life. Thus factors in early childhood influenced adult pulmonary function in either of two ways. First, it was hypothesized that childhood factors diminished the maximally attained level of lung function in early adult life, thus increasing the likelihood that, with a fixed rate of decline in adult life, these individuals would be more likely to develop symptoms. Alternatively, childhood events might act directly to increase the risk of developing a more rapid rated decline in pulmonary function in adult life. The above theory had a plausible patho-anatomic basis. The lung is one of the last organs in the body to mature and children continue to make alveoli up until the age of six or seven. Thus risk factors both environmental, such as respiratory illness, active and passive cigarette smoke, and host airways responsiveness and atopy, could adversely influence lung growth and lead to less maximal lung growth and/or increased sensitivity to cigarette smoking in adult life.

This study was a subproject in a Specialized Center of Research in Chronic Diseases of the Airways. The East Boston cohort was developed in 1975 under contract issued by the Division of Lung Diseases.

DESIGN NARRATIVE:

In 1975 a stratified, random sample of propositus children ages 5-9 living in the East Boston area of Boston, Massachusetts was selected as were their family members to form the cohort. In the longitudinal study, each member of the propositus cohort and all family members five years of age and older residing in the household were visited at home annually by study personnel. Data collected included: a respiratory illness history; demographic data on type of heating, fuel for cooking, types of air-purifying devices, and area of residence; cigarette smoking history; disability from cardiac disease; age of puberty in female children; pulmonary function tests; and anthropometric data. The study helped to determine the extent to which airways responsiveness was a risk factor for chronic airflow obstruction, was acquired as a result of other exposures or as a consequence of chronic symptoms or lower levels of pulmonary function.

Each year study families were requested to participate in the cold air challenge protocol. Subjects participating in this protocol were studied in a laboratory at the community health center. Forced expiratory volumes were obtained followed by a cold air challenge test using the technique of eucapneic hyperventilation with subfreezing air. The cold air challenge test separated normals from asthmatics. Two inhalations of isoproterenol were administered one minute apart after which three forced vital capacity maneuvers were performed. After pulmonary function tests were completed, allergy tests were conducted for ragweed, trees, house dust, and grasses.

The study was renewed in 1992 to examine the relationship of respiratory symptoms and illnesses, cigarette smoking, airways responsiveness, and markers of inflammation to growth and decline in lung function in two well-characterized and investigated community-based populations of children and adults. Data were available in two populations: the Childhood Respiratory Disease Study in East Boston (CRD) and the Normative Aging Study Population (NAS). This group has shown that increased airway responsiveness was associated with altered patterns of lung growth (in children) and reduced levels of lung function (in adults). They also have shown that airway responsiveness was cross-sectionally associated with chronic respiratory symptoms in both children and adults. However, asymptomatic airway responsiveness was extremely common, occurring in 20 percent to 60 percent of responsive subjects, depending on how responsiveness and chronic symptoms were defined. Asymptomatic bronchial responsiveness was thought to represent subclinical or mild airway inflammation. Alternatively, it may have represented differences in mechanical factors leading to airway narrowing.

Funding represented approximately 15 percent of the dollars of the Specialized Center of Research in Chronic Diseases of the Airways (P50HL19170) used to support this study.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) rec

Medical subject headings
Lung Diseases, Asthma, 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 startDec 1981
  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
NCT00005282
Sponsor's protocol ID
2003
Other IDs
P50HL019170
Status last verified
Apr 2001
First submitted
25 May 2000
Last updated
18 Feb 2016
Results posted
No

Publications

  • Tollerud DJ, Weiss ST, Leung DY. Elevated soluble interleukin-2 receptors in young healthy cigarette smokers: lack of association with atopy or airways hyperresponsiveness. Int Arch Allergy Immunol. 1992;97(1):25-30. doi: 10.1159/000236091.

    PubMed 1582694
  • Weiss ST. Diet as a risk factor for asthma. Ciba Found Symp. 1997;206:244-57: discussion 253-7.

    PubMed 9257017
  • Sparrow D, O'Connor GT, Weiss ST, DeMolles D, Ingram RH Jr. Volume history effects and airway responsiveness in middle-aged and older men. The Normative Aging Study. Am J Respir Crit Care Med. 1997 Mar;155(3):888-92. doi: 10.1164/ajrccm.155.3.9117022.

    PubMed 9117022
  • Shadick NA, Sparrow D, O'Connor GT, DeMolles D, Weiss ST. Relationship of serum IgE concentration to level and rate of decline of pulmonary function: the Normative Aging Study. Thorax. 1996 Aug;51(8):787-92. doi: 10.1136/thx.51.8.787.

    PubMed 8795665
  • Weiss ST, Segal MR, Sparrow D, Wager C. Relation of FEV1 and peripheral blood leukocyte count to total mortality. The Normative Aging Study. Am J Epidemiol. 1995 Sep 1;142(5):493-8; discussion 499-503. doi: 10.1093/oxfordjournals.aje.a117665.

    PubMed 7677128
  • Carey VJ, Weiss ST, Tager IB, Leeder SR, Speizer FE. Airways responsiveness, wheeze onset, and recurrent asthma episodes in young adolescents. The East Boston Childhood Respiratory Disease Cohort. Am J Respir Crit Care Med. 1996 Jan;153(1):356-61. doi: 10.1164/ajrccm.153.1.8542143.

    PubMed 8542143
  • Tager IB, Weiss ST, Rosner B, Speizer FE. Effect of parental cigarette smoking on the pulmonary function of children. Am J Epidemiol. 1979 Jul;110(1):15-26. doi: 10.1093/oxfordjournals.aje.a112783.

    PubMed 463860
  • Weiss ST, Tager IB, Speizer FE, Rosner B. Persistent wheeze. Its relation to respiratory illness, cigarette smoking, and level of pulmonary function in a population sample of children. Am Rev Respir Dis. 1980 Nov;122(5):697-707. doi: 10.1164/arrd.1980.122.5.697.

    PubMed 7447154
  • Weinberger SE, Weiss ST, Johnson TS, von Gal E, Balsavich L. Naloxone does not affect bronchoconstriction induced by isocapnic hyperpnea of subfreezing air. Am Rev Respir Dis. 1982 Sep;126(3):468-71. doi: 10.1164/arrd.1982.126.3.468.

    PubMed 7125336
  • Weiss ST, Tager IB, Schenker M, Speizer FE. The health effects of involuntary smoking. Am Rev Respir Dis. 1983 Nov;128(5):933-42. doi: 10.1164/arrd.1983.128.5.933.

    PubMed 6638684
  • Weiss ST, Tager IB, Speizer FE. Passive smoking. Its relationship to respiratory symptoms, pulmonary function and nonspecific bronchial responsiveness. Chest. 1983 Dec;84(6):651-2. doi: 10.1378/chest.84.6.651. No abstract available.

    PubMed 6641294
  • Tager IB, Weiss ST, Munoz A, Rosner B, Speizer FE. Longitudinal study of the effects of maternal smoking on pulmonary function in children. N Engl J Med. 1983 Sep 22;309(12):699-703. doi: 10.1056/NEJM198309223091204.

    PubMed 6888441
  • Pichurko BM, Weiss ST. The role of infection in asthma: implications for antibiotic therapy. Compr Ther. 1984 Mar;10(3):32-6.

    PubMed 6713812
  • Weiss ST, Tager IB, Weiss JW, Munoz A, Speizer FE, Ingram RH. Airways responsiveness in a population sample of adults and children. Am Rev Respir Dis. 1984 Jun;129(6):898-902. doi: 10.1164/arrd.1984.129.6.898.

    PubMed 6610372
  • Weiss ST, Tager IB, Weiss JW, Munoz A, Speizer FE, Ingram RH Jr: The Relationship of Physician-Diagnosed Croup or Bronchiolitis to the Subsequent Development of Increased Levels of Airways Responsiveness. Chest, 85S:9S-10S, 1984

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Diseases and Asthma, 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 NCT00005282, which also lists 43 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.

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