Lung DiseasesNCT00005298
Inflammation, Autonomic Dysfunction and Airway Disease
An observational study of Lung Diseases and Asthma, run by National Heart, Lung, and Blood Institute (NHLBI).
Trial summary
To determine whether airway inflammation secondary to inhalation of specific allergens and other environmental agents and functional imbalance of the autonomic nervous system played important roles in asthma and chronic bronchitis. Read more about this study
- Who is it for?
- Ages Up to 100 years, men only
- Conditions the study is for
- Lung Diseases, Asthma, Bronchitis
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1990to Jun 1993
- 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 whether airway inflammation secondary to inhalation of specific allergens and other environmental agents and functional imbalance of the autonomic nervous system played important roles in asthma and chronic bronchitis.
Read the detailed description
BACKGROUND:
Asthma and chronic bronchitis are among the most common chronic diseases afflicting middle-aged and elderly adults in the United States, respectively occurring in 4 percent and 5 percent of the population in these age groups. While chronic bronchitis is often caused by cigarette smoking and asthma often occurs in nonsmokers in association with atopy, the two conditions may be difficult to differentiate in many middle-aged and older adults and may share a number of pathophysiologic features including increased airway smooth muscle tone, increased airway responsiveness to bronchoconstricting stimuli, and bronchial mucus hypersecretion. The precise mechanisms which produce the alterations of airway function are not clear. Such functional alterations may be caused by airway inflammation and abnormalities of the autonomic nervous system; however, there are little population data available regarding the importance of airway inflammation and disordered neural regulation in the pathogenesis of airway hyperresponsiveness and mucus hypersecretion. Also, little is known about potential interactions between airway inflammation and disordered neural regulation of airway function in the pathogenesis of chronic airways disease. Information on the relationships may offer insights into the pathophysiologic mechanisms underlying asthma and chronic bronchitis in adults.
DESIGN NARRATIVE:
The study was cross-sectional and used a subgroup of the Normative Aging Study, a longitudinal study of aging in men established by the Veterans Administration in 1963. The study used data normally collected during NAS examinations and included smoking history, socio-economic status, anthropometry, respiratory symptoms and illnesses, and pulmonary function. New data were collected on: indices of inflammation as indicated by histamine, leukotriene, and serotonin in urine; autonomic activity as indicated by urinary catecholamine excretion and heart rate variation induced by deep breathing; autonomic responsiveness as measured by pupillary alpha-adrenergic and cholinergic responses.
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
- Lung Diseases, Asthma, Bronchitis, Inflammation
- Medical subject headings
- Lung Diseases, Asthma, Bronchitis, Inflammation
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 1990
- Study completionJun 1993
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies 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
- NCT00005298
- Sponsor's protocol ID
- 2021
- Other IDs
- R01HL045089
- Status last verified
- Jun 2000
- First submitted
- 25 May 2000
- Last updated
- 16 Mar 2016
- Results posted
- No
Publications
Lazarus R, Sparrow D, Weiss ST. Effects of obesity and fat distribution on ventilatory function: the normative aging study. Chest. 1997 Apr;111(4):891-8. doi: 10.1378/chest.111.4.891.
PubMed 9106566Sparrow 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 9117022Shadick 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, 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 1372851Freeman R, Weiss ST, Roberts M, Zbikowski SM, Sparrow D. The relationship between heart rate variability and measures of body habitus. Clin Auton Res. 1995 Oct;5(5):261-6. doi: 10.1007/BF01818890.
PubMed 8563458O'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 7599868Annema JT, Sparrow D, O'Connor GT, Rijcken B, Koeter GH, Postma DS, Weiss ST. Chronic respiratory symptoms and airway responsiveness to methacholine are associated with eosinophilia in older men: the Normative Aging Study. Eur Respir J. 1995 Jan;8(1):62-9. doi: 10.1183/09031936.95.08010062.
PubMed 7744195Kawachi I, Sparrow D, Vokonas PS, Weiss ST. Decreased heart rate variability in men with phobic anxiety (data from the Normative Aging Study). Am J Cardiol. 1995 May 1;75(14):882-5. doi: 10.1016/s0002-9149(99)80680-8.
PubMed 7732994Ward KD, Sparrow D, Vokonas PS, Willett WC, Landsberg L, Weiss ST. The relationships of abdominal obesity, hyperinsulinemia and saturated fat intake to serum lipid levels: the Normative Aging Study. Int J Obes Relat Metab Disord. 1994 Mar;18(3):137-44.
PubMed 8186810Ward KD, Sparrow D, Landsberg L, Young JB, Vokonas PS, Weiss ST. The relationship of epinephrine excretion to serum lipid levels: the Normative Aging Study. Metabolism. 1994 Apr;43(4):509-13. doi: 10.1016/0026-0495(94)90085-x.
PubMed 8159112O'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 8131522Sparrow D, O'Connor GT, Rosner B, Weiss ST. Predictors of longitudinal change in methacholine airway responsiveness among middle-aged and older men: the Normative Aging Study. Am J Respir Crit Care Med. 1994 Feb;149(2 Pt 1):376-81. doi: 10.1164/ajrccm.149.2.8306033.
PubMed 8306033Weiss ST, Sparrow D, O'Connor GT. The interrelationship among allergy, airways responsiveness, and asthma. J Asthma. 1993;30(5):329-49. doi: 10.3109/02770909309056738. No abstract available.
PubMed 8407734Sparrow D, O'Connor GT, Rosner B, DeMolles D, Weiss ST. A longitudinal study of plasma cortisol concentration and pulmonary function decline in men. The Normative Aging Study. Am Rev Respir Dis. 1993 Jun;147(6 Pt 1):1345-8. doi: 10.1164/ajrccm/147.6_Pt_1.1345.
PubMed 8503543Ohman JL Jr, Sparrow D, MacDonald MR. New onset wheezing in an older male population: evidence of allergen sensitization in a longitudinal study. Results of the normative aging study. J Allergy Clin Immunol. 1993 Mar;91(3):752-7. doi: 10.1016/0091-6749(93)90195-l.
PubMed 8454798
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
- Inflammation, Autonomic Dysfunction and Airway Disease
- ClinicalTrials.gov ID
- NCT00005298
- Acronym / sponsor ID
- 2021
- Conditions
- Lung Diseases, Asthma, Bronchitis, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 1990
- Study completion
- Jun 1993 (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 whether airway inflammation secondary to inhalation of specific allergens and other environmental agents and functional imbalance of the autonomic nervous system played important roles in asthma and chronic bronchitis.
Detailed description
BACKGROUND:
Asthma and chronic bronchitis are among the most common chronic diseases afflicting middle-aged and elderly adults in the United States, respectively occurring in 4 percent and 5 percent of the population in these age groups. While chronic bronchitis is often caused by cigarette smoking and asthma often occurs in nonsmokers in association with atopy, the two conditions may be difficult to differentiate in many middle-aged and older adults and may share a number of pathophysiologic features including increased airway smooth muscle tone, increased airway responsiveness to bronchoconstricting stimuli, and bronchial mucus hypersecretion. The precise mechanisms which produce the alterations of airway function are not clear. Such functional alterations may be caused by airway inflammation and abnormalities of the autonomic nervous system; however, there are little population data available regarding the importance of airway inflammation and disordered neural regulation in the pathogenesis of airway hyperresponsiveness and mucus hypersecretion. Also, little is known about potential interactions between airway inflammation and disordered neural regulation of airway function in the pathogenesis of chronic airways disease. Information on the relationships may offer insights into the pathophysiologic mechanisms underlying asthma and chronic bronchitis in adults.
DESIGN NARRATIVE:
The study was cross-sectional and used a subgroup of the Normative Aging Study, a longitudinal study of aging in men established by the Veterans Administration in 1963. The study used data normally collected during NAS examinations and included smoking history, socio-economic status, anthropometry, respiratory symptoms and illnesses, and pulmonary function. New data were collected on: indices of inflammation as indicated by histamine, leukotriene, and serotonin in urine; autonomic activity as indicated by urinary catecholamine excretion and heart rate variation induced by deep breathing; autonomic responsiveness as measured by pupillary alpha-adrenergic and cholinergic responses.
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 9106566Lazarus R, Sparrow D, Weiss ST. Effects of obesity and fat distribution on ventilatory function: the normative aging study. Chest. 1997 Apr;111(4):891-8. doi: 10.1378/chest.111.4.891.
- 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 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 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 8563458Freeman R, Weiss ST, Roberts M, Zbikowski SM, Sparrow D. The relationship between heart rate variability and measures of body habitus. Clin Auton Res. 1995 Oct;5(5):261-6. doi: 10.1007/BF01818890.
- Background: PubMed 7599868O'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.
- Background: PubMed 7744195Annema JT, Sparrow D, O'Connor GT, Rijcken B, Koeter GH, Postma DS, Weiss ST. Chronic respiratory symptoms and airway responsiveness to methacholine are associated with eosinophilia in older men: the Normative Aging Study. Eur Respir J. 1995 Jan;8(1):62-9. doi: 10.1183/09031936.95.08010062.
- Background: PubMed 7732994Kawachi I, Sparrow D, Vokonas PS, Weiss ST. Decreased heart rate variability in men with phobic anxiety (data from the Normative Aging Study). Am J Cardiol. 1995 May 1;75(14):882-5. doi: 10.1016/s0002-9149(99)80680-8.
- Background: PubMed 8186810Ward KD, Sparrow D, Vokonas PS, Willett WC, Landsberg L, Weiss ST. The relationships of abdominal obesity, hyperinsulinemia and saturated fat intake to serum lipid levels: the Normative Aging Study. Int J Obes Relat Metab Disord. 1994 Mar;18(3):137-44.
- Background: PubMed 8159112Ward KD, Sparrow D, Landsberg L, Young JB, Vokonas PS, Weiss ST. The relationship of epinephrine excretion to serum lipid levels: the Normative Aging Study. Metabolism. 1994 Apr;43(4):509-13. doi: 10.1016/0026-0495(94)90085-x.
- Background: PubMed 8131522O'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.
- Background: PubMed 8306033Sparrow D, O'Connor GT, Rosner B, Weiss ST. Predictors of longitudinal change in methacholine airway responsiveness among middle-aged and older men: the Normative Aging Study. Am J Respir Crit Care Med. 1994 Feb;149(2 Pt 1):376-81. doi: 10.1164/ajrccm.149.2.8306033.
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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 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 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 NCT00005298, which also lists 17 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.