AsthmaNCT00005284
Epidemiology of Airway Responsiveness
An observational study of Asthma and Lung Diseases, Obstructive, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To prospectively identify factors that influence the rate of decline in pulmonary function and to identify predictors of chronic obstructive lung disease (COLD) and asthma in a population sample of older adults. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Asthma, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jan 1985to Mar 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 prospectively identify factors that influence the rate of decline in pulmonary function and to identify predictors of chronic obstructive lung disease (COLD) and asthma in a population sample of older adults.
Read the detailed description
BACKGROUND:
Cigarette smoking is recognized as the most important factor in the development of chronic airflow obstruction, yet only a minority of cigarette smokers develop clinical disease. In 1985, interest focused on the role of increased levels of airways responsiveness and atopy as possible potentiating factors for the development of chronic airflow obstruction. Then current epidemiologic studies had data on only one of these potential risk factors or were too small to adequately address the issues involved. The present study assesses both airways responsiveness and atopy.
DESIGN NARRATIVE:
The study used the population and data base of the Veterans Administration Normative Aging Study (NAS) which began in 1963. The NAS population consists of over 1,900 men originally selected for good health and their wives. The NAS currently administers a cigarette smoking history questionnaire, the NHLBI-ATS respiratory symptom and illness questionnaire, and spirometry at regularly scheduled examinations three years apart. The current study assessed airways responsiveness as measured by response to methacholine inhalation and atopy as measured by skin test, blood eosinophilia, and serum IgE in NAS participants when they returned for their next two examinations. The data were used to examine the relationship of airways responsiveness, atopy, and cigarette smoking to respiratory symptoms both cross-sectionally and longitudinally.
The study was renewed in 1996 to prospectively identify factors that influence the rate of decline in pulmonary function and to identify predictors of chronic obstructive lung disease (COLD) and asthma in a population sample of older adults. The investigators hypothesize that the development of accelerated decline in FEV1 and the occurrence of respiratory symptoms in older adults are determined by two environmental exposures: tobacco smoke-induced injury and IgE-mediated hypersensitivity to inhaled aeroallergens. The extent to which allergen exposure and airway responsiveness lead to fixed airflow obstruction in older adults is unknown. The primary allergens of interest include: house dust mite (Der p I, Der fI), cockroach (Bla g I, Bla g II), cat (Fel d I), and fungi. Airway hyperresponsiveness to bronchoconstricting stimuli is a physiologic characteristic that may be thought of both as a manifestation of airway disease and as an intrinsic host characteristic which predisposes to the development of airway disease and determines its clinical pattern. They are using the extensive longitudinal information on respiratory symptoms and illnesses, cigarette smoking, pulmonary function, airway responsiveness, indices of atopy (skin test, total and antigen-specific IgE), indices of inflammation (eosinophil and leukocyte counts in peripheral blood), and allergen levels in dust and air in NAS participants and their wives to address the following hypotheses: that the association of increased airway responsiveness with accelerated longitudinal decline in pulmonary function is modified by gender, smoking, level of FEV1, and skin test reactivity;. that the level of exposure to common indoor allergens affects the rate of longitudinal decline of pulmonary function; that high levels of exposure to common indoor allergens leads to longitudinal increases in airway responsiveness over time; and that settled dust levels of fungi (culturable and countable organisms) and antigens, cockroach (Bla g l, Bla g II], and cat (Fel d I) are correlated with airborne levels of these agents.
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, 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 startJan 1985
- Study completionMar 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)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
- Scott Weiss, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005284
- Sponsor's protocol ID
- 2005
- Other IDs
- R01HL034645
- Status last verified
- Aug 2004
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
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 8795665Sparrow 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 9117022Gottlieb DJ, Stone PJ, Sparrow D, Gale ME, Weiss ST, Snider GL, O'Connor GT. Urinary desmosine excretion in smokers with and without rapid decline of lung function: the Normative Aging Study. Am J Respir Crit Care Med. 1996 Nov;154(5):1290-5. doi: 10.1164/ajrccm.154.5.8912738.
PubMed 8912738Sparrow D, O'Connor G, Weiss ST. The relation of airways responsiveness and atopy to the development of chronic obstructive lung disease. Epidemiol Rev. 1988;10:29-47. doi: 10.1093/oxfordjournals.epirev.a036027. No abstract available.
PubMed 3066629O'Connor GT, Sparrow D, Weiss ST. The role of allergy and nonspecific airway hyperresponsiveness in the pathogenesis of chronic obstructive pulmonary disease. Am Rev Respir Dis. 1989 Jul;140(1):225-52. doi: 10.1164/ajrccm/140.1.225.
PubMed 2665587O'Connor GT, Sparrow D, Segal MR, Weiss ST. Smoking, atopy, and methacholine airway responsiveness among middle-aged and elderly men. The Normative Aging Study. Am Rev Respir Dis. 1989 Dec;140(6):1520-6. doi: 10.1164/ajrccm/140.6.1520.
PubMed 2690701Parker DR, O'Connor GT, Sparrow D, Segal MR, Weiss ST. The relationship of nonspecific airway responsiveness and atopy to the rate of decline of lung function. The Normative Aging Study. Am Rev Respir Dis. 1990 Mar;141(3):589-94. doi: 10.1164/ajrccm/141.3.589.
PubMed 2178525Sparrow D, O'Connor GT, Young JB, Rosner B, Weiss ST. Relationship of urinary serotonin excretion to cigarette smoking and respiratory symptoms. The Normative Aging Study. Chest. 1992 Apr;101(4):976-80. doi: 10.1378/chest.101.4.976.
PubMed 1372851Schwartz J, Weiss ST. Caffeine intake and asthma symptoms. Ann Epidemiol. 1992 Sep;2(5):627-35. doi: 10.1016/1047-2797(92)90007-d.
PubMed 1342314Schwartz J, Weiss ST. Host and environmental factors influencing the peripheral blood leukocyte count. Am J Epidemiol. 1991 Dec 15;134(12):1402-9. doi: 10.1093/oxfordjournals.aje.a116045.
PubMed 1776614Tollerud DJ, O'Connor GT, Sparrow D, Weiss ST. Asthma, hay fever, and phlegm production associated with distinct patterns of allergy skin test reactivity, eosinophilia, and serum IgE levels. The Normative Aging Study. Am Rev Respir Dis. 1991 Oct;144(4):776-81. doi: 10.1164/ajrccm/144.4.776.
PubMed 1928948Sparrow D, O'Connor GT, Rosner B, Weiss ST. Methacholine airway responsiveness and 24-hour urine excretion of sodium and potassium. The Normative Aging Study. Am Rev Respir Dis. 1991 Sep;144(3 Pt 1):722-5. doi: 10.1164/ajrccm/144.3_Pt_1.722.
PubMed 1892316Sparrow D, O'Connor GT, Rosner B, Segal MR, Weiss ST. The influence of age and level of pulmonary function on nonspecific airway responsiveness. The Normative Aging Study. Am Rev Respir Dis. 1991 May;143(5 Pt 1):978-82. doi: 10.1164/ajrccm/143.5_Pt_1.978.
PubMed 2024853O'Connor GT, Sparrow D, Weiss ST. A prospective longitudinal study of methacholine airway responsiveness as a predictor of pulmonary-function decline: the Normative Aging Study. Am J Respir Crit Care Med. 1995 Jul;152(1):87-92. doi: 10.1164/ajrccm.152.1.7599868.
PubMed 7599868O'Connor GT, Sparrow D, Weiss ST. Normal range of methacholine responsiveness in relation to prechallenge pulmonary function. The Normative Aging Study. Chest. 1994 Mar;105(3):661-6. doi: 10.1378/chest.105.3.661.
PubMed 8131522
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
- Epidemiology of Airway Responsiveness
- ClinicalTrials.gov ID
- NCT00005284
- Acronym / sponsor ID
- 2005
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jan 1985
- Study completion
- Mar 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 prospectively identify factors that influence the rate of decline in pulmonary function and to identify predictors of chronic obstructive lung disease (COLD) and asthma in a population sample of older adults.
Detailed description
BACKGROUND:
Cigarette smoking is recognized as the most important factor in the development of chronic airflow obstruction, yet only a minority of cigarette smokers develop clinical disease. In 1985, interest focused on the role of increased levels of airways responsiveness and atopy as possible potentiating factors for the development of chronic airflow obstruction. Then current epidemiologic studies had data on only one of these potential risk factors or were too small to adequately address the issues involved. The present study assesses both airways responsiveness and atopy.
DESIGN NARRATIVE:
The study used the population and data base of the Veterans Administration Normative Aging Study (NAS) which began in 1963. The NAS population consists of over 1,900 men originally selected for good health and their wives. The NAS currently administers a cigarette smoking history questionnaire, the NHLBI-ATS respiratory symptom and illness questionnaire, and spirometry at regularly scheduled examinations three years apart. The current study assessed airways responsiveness as measured by response to methacholine inhalation and atopy as measured by skin test, blood eosinophilia, and serum IgE in NAS participants when they returned for their next two examinations. The data were used to examine the relationship of airways responsiveness, atopy, and cigarette smoking to respiratory symptoms both cross-sectionally and longitudinally.
The study was renewed in 1996 to prospectively identify factors that influence the rate of decline in pulmonary function and to identify predictors of chronic obstructive lung disease (COLD) and asthma in a population sample of older adults. The investigators hypothesize that the development of accelerated decline in FEV1 and the occurrence of respiratory symptoms in older adults are determined by two environmental exposures: tobacco smoke-induced injury and IgE-mediated hypersensitivity to inhaled aeroallergens. The extent to which allergen exposure and airway responsiveness lead to fixed airflow obstruction in older adults is unknown. The primary allergens of interest include: house dust mite (Der p I, Der fI), cockroach (Bla g I, Bla g II), cat (Fel d I), and fungi. Airway hyperresponsiveness to bronchoconstricting stimuli is a physiologic characteristic that may be thought of both as a manifestation of airway disease and as an intrinsic host characteristic which predisposes to the development of airway disease and determines its clinical pattern. They are using the extensive longitudinal information on respiratory symptoms and illnesses, cigarette smoking, pulmonary function, airway responsiveness, indices of atopy (skin test, total and antigen-specific IgE), indices of inflammation (eosinophil and leukocyte counts in peripheral blood), and allergen levels in dust and air in NAS participants and their wives to address the following hypotheses: that the association of increased airway responsiveness with accelerated longitudinal decline in pulmonary function is modified by gender, smoking, level of FEV1, and skin test reactivity;. that the level of exposure to common indoor allergens affects the rate of longitudinal decline of pulmonary function; that high levels of exposure to common indoor allergens leads to longitudinal increases in airway responsiveness over time; and that settled dust levels of fungi (culturable and countable organisms) and antigens, cockroach (Bla g l, Bla g II], and cat (Fel d I) are correlated with airborne levels of these agents.
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 8795665Shadick 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.
- Background: PubMed 9117022Sparrow 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.
- Background: PubMed 8912738Gottlieb DJ, Stone PJ, Sparrow D, Gale ME, Weiss ST, Snider GL, O'Connor GT. Urinary desmosine excretion in smokers with and without rapid decline of lung function: the Normative Aging Study. Am J Respir Crit Care Med. 1996 Nov;154(5):1290-5. doi: 10.1164/ajrccm.154.5.8912738.
- Background: PubMed 3066629Sparrow D, O'Connor G, Weiss ST. The relation of airways responsiveness and atopy to the development of chronic obstructive lung disease. Epidemiol Rev. 1988;10:29-47. doi: 10.1093/oxfordjournals.epirev.a036027. No abstract available.
- Background: PubMed 2665587O'Connor GT, Sparrow D, Weiss ST. The role of allergy and nonspecific airway hyperresponsiveness in the pathogenesis of chronic obstructive pulmonary disease. Am Rev Respir Dis. 1989 Jul;140(1):225-52. doi: 10.1164/ajrccm/140.1.225.
- Background: PubMed 2690701O'Connor GT, Sparrow D, Segal MR, Weiss ST. Smoking, atopy, and methacholine airway responsiveness among middle-aged and elderly men. The Normative Aging Study. Am Rev Respir Dis. 1989 Dec;140(6):1520-6. doi: 10.1164/ajrccm/140.6.1520.
- Background: PubMed 2178525Parker DR, O'Connor GT, Sparrow D, Segal MR, Weiss ST. The relationship of nonspecific airway responsiveness and atopy to the rate of decline of lung function. The Normative Aging Study. Am Rev Respir Dis. 1990 Mar;141(3):589-94. doi: 10.1164/ajrccm/141.3.589.
- Background: PubMed 1372851Sparrow D, O'Connor GT, Young JB, Rosner B, Weiss ST. Relationship of urinary serotonin excretion to cigarette smoking and respiratory symptoms. The Normative Aging Study. Chest. 1992 Apr;101(4):976-80. doi: 10.1378/chest.101.4.976.
- Background: PubMed 1342314Schwartz J, Weiss ST. Caffeine intake and asthma symptoms. Ann Epidemiol. 1992 Sep;2(5):627-35. doi: 10.1016/1047-2797(92)90007-d.
- Background: PubMed 1776614Schwartz J, Weiss ST. Host and environmental factors influencing the peripheral blood leukocyte count. Am J Epidemiol. 1991 Dec 15;134(12):1402-9. doi: 10.1093/oxfordjournals.aje.a116045.
- Background: PubMed 1928948Tollerud DJ, O'Connor GT, Sparrow D, Weiss ST. Asthma, hay fever, and phlegm production associated with distinct patterns of allergy skin test reactivity, eosinophilia, and serum IgE levels. The Normative Aging Study. Am Rev Respir Dis. 1991 Oct;144(4):776-81. doi: 10.1164/ajrccm/144.4.776.
- Background: PubMed 1892316Sparrow D, O'Connor GT, Rosner B, Weiss ST. Methacholine airway responsiveness and 24-hour urine excretion of sodium and potassium. The Normative Aging Study. Am Rev Respir Dis. 1991 Sep;144(3 Pt 1):722-5. doi: 10.1164/ajrccm/144.3_Pt_1.722.
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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.
Scott Weiss
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Lung Diseases, Obstructive, 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 NCT00005284, which also lists 28 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.