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CompletedNCT00005298Updated Mar 16, 2016

Inflammation, Autonomic Dysfunction and Airway Disease

An observational study in Lung Diseases, Asthma and Bronchitis, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed. Open to male participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2016-03-16.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Ages
Up to 100 Years
Sex
Male
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Study 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 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.

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Conditions studied

  • Lung Diseases
  • Asthma
  • Bronchitis
  • Inflammation
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In context

Bronchitis

268 studies on the registry are indexed under Bronchitis; 26 are open to participants now.

Browse Bronchitis studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Eligibility criteria

No eligibility criteria

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Study design

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Study locations

No study locations are listed for this record.

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References and documents

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 9106566 ↗
  • 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 ↗
  • Sparrow 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 1372851 ↗
  • Freeman 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 8563458 ↗
  • O'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 7599868 ↗
  • Annema 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 7744195 ↗
  • Kawachi 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 7732994 ↗
  • Ward 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 8186810 ↗
  • Ward 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 8159112 ↗
  • O'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 ↗
  • Sparrow 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 8306033 ↗
  • Weiss 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 8407734 ↗
  • Sparrow 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 8503543 ↗
  • Ohman 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 ↗
  • O'Connor GT, Sparrow D, Segal M, Weiss ST. Risk factors for ventilatory impairment among middle-aged and elderly men. The Normative Aging Study. Chest. 1993 Feb;103(2):376-82. doi: 10.1378/chest.103.2.376. PubMed 8432122 ↗
  • Sparrow D, O'Connor GT, Basner RC, Rosner B, Weiss ST. Predictors of the new onset of wheezing among middle-aged and older men. The Normative Aging Study. Am Rev Respir Dis. 1993 Feb;147(2):367-71. doi: 10.1164/ajrccm/147.2.367. PubMed 8430960 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00005298
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
First posted
May 26, 2000
Start date
Jul 1990
Completion
Jun 1993
Last update
Mar 16, 2016
View the source record on ClinicalTrials.gov ↗

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