Idiopathic Pulmonary Fibrosis--Pathogenesis and Staging - SCOR in Occupational and Immunological Lung Diseases
Primary Purpose
Lung Diseases, Pulmonary Fibrosis, Lung Diseases, Interstitial
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Lung Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005317
First Posted
May 25, 2000
Last Updated
July 11, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005317
Brief Title
Idiopathic Pulmonary Fibrosis--Pathogenesis and Staging - SCOR in Occupational and Immunological Lung Diseases
Study Type
Observational
2. Study Status
Record Verification Date
May 2000
Overall Recruitment Status
Completed
Study Start Date
December 1986 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 1996 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To conduct cross-sectional and longitudinal studies of patients with idiopathic pulmonary fibrosis (IPF) and patients with progressive systemic sclerosis (PSS), with and without associated lung disease.
Detailed Description
BACKGROUND:
Idiopathic pulmonary fibrosis (IPF) is a disease of unknown etiology characterized pathologically by a chronic inflammatory process (alveolitis) that precedes and likely controls the alterations in connective tissue matrix that eventually destroys the normal lung architecture. The mechanisms involved in this process are not known. A complex cell-cell interactive sequence, involving principally neutrophils, lymphocytes, macrophages, fibroblast, and epithelial cells is believed to be responsible.
The SCOR in Occupational and Immunological Lung Diseases was first awarded in December, 1981. The subproject on idiopathic pulmonary fibrosis was first awarded in December, 1986.
DESIGN NARRATIVE:
The cross-sectional comparison examined bronchoalveolar lavage, high resolution, thin-section computer tomography (HRCT), neutrophil or monocyte labeled scintigraphy). The serial, longitudinal evaluation monitored the progression of disease. The study of PSS patients, without disease or with subclinical disease, was particularly useful because it allowed examination of the early events in the pathogenesis of IPF. The long-term goal of the project was to determine what alterations in cellular composition, function and trafficking occurred in the lung parenchyma of patients with IPF and to relate these alterations to the disease stage, prognosis, and therapeutic responsiveness.
The major objectives of the study were: (1) to continue the prospective, longitudinal study of carefully defined cases of IPF; (2) to initiate a study of patients with PSS, a disease that provided a useful paradigm for studying the early events of the disease; (3) to determine the role of the lymphocyte in IPF, by defining the subset of T lymphocytes responsible for modulating macrophage function; (4) to establish the role of non-invasive techniques (bronchoalveolar lavage (BAL), HRCT scanning and scintigraphy -- neutrophil and monocyte labelled cells) in assessing the activity of inflammation in carefully evaluated patients; (5) to determine the relationship of these results to the -- carefully defined and serially obtained -- clinical, radiographical, and physiological findings and to the histopathologic abnormalities (in patients that underwent lung biopsy, predominantly IPF cases). (6) to perform studies utilizing blood, BAL fluid and lung tissue in an effort to understand the pathogenic mechanisms that underlied the inflammatory/immune cellular injury and fibrosis that characterize this disease.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Pulmonary Fibrosis, Lung Diseases, Interstitial, Scleroderma, Systemic
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
7735621
Citation
Janson RW, Hance KR, King TE Jr. Human alveolar macrophages produce predominantly the 35-kD pro-forms of interleukin-1 alpha and interleukin-1 beta when stimulated with lipopolysaccharide. Am J Respir Crit Care Med. 1995 May;151(5):1613-20. doi: 10.1164/ajrccm.151.5.7735621.
Results Reference
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PubMed Identifier
7697250
Citation
Cherniack RM, Colby TV, Flint A, Thurlbeck WM, Waldron JA Jr, Ackerson L, Schwarz MI, King TE Jr. Correlation of structure and function in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 1995 Apr;151(4):1180-8. doi: 10.1164/ajrccm/151.4.1180.
Results Reference
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PubMed Identifier
3059868
Citation
Willcox M, Kervitsky A, Watters LC, King TE Jr. Quantification of cells recovered by bronchoalveolar lavage. Comparison of cytocentrifuge preparations with the filter method. Am Rev Respir Dis. 1988 Jul;138(1):74-80. doi: 10.1164/ajrccm/138.1.74.
Results Reference
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PubMed Identifier
9180223
Citation
Salvatore M, Seeber AC, Nacmias B, Petraroli R, Sorbi S, Pocchiari M. Alpha1 antichymotrypsin signal peptide polymorphism in sporadic Creutzfeldt-Jakob disease. Neurosci Lett. 1997 May 16;227(2):140-2. doi: 10.1016/s0304-3940(97)00308-x.
Results Reference
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PubMed Identifier
2492173
Citation
Savici D, Campbell PA, King TE Jr. Bronchoalveolar macrophages from patients with idiopathic pulmonary fibrosis are unable to kill facultative intracellular bacteria. Am Rev Respir Dis. 1989 Jan;139(1):22-7. doi: 10.1164/ajrccm/139.1.22.
Results Reference
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PubMed Identifier
2604297
Citation
Kuhn C 3rd, Boldt J, King TE Jr, Crouch E, Vartio T, McDonald JA. An immunohistochemical study of architectural remodeling and connective tissue synthesis in pulmonary fibrosis. Am Rev Respir Dis. 1989 Dec;140(6):1693-703. doi: 10.1164/ajrccm/140.6.1693.
Results Reference
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PubMed Identifier
1416394
Citation
Hyde DM, King TE Jr, McDermott T, Waldron JA Jr, Colby TV, Thurlbeck WM, Flint WM, Ackerson L, Cherniack RM. Idiopathic pulmonary fibrosis. Quantitative assessment of lung pathology. Comparison of a semiquantitative and a morphometric histopathologic scoring system. Am Rev Respir Dis. 1992 Oct;146(4):1042-7. doi: 10.1164/ajrccm/146.4.1042.
Results Reference
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PubMed Identifier
1414806
Citation
Buschman DL, Gamsu G, Waldron JA Jr, Klein JS, King TE Jr. Chronic hypersensitivity pneumonitis: use of CT in diagnosis. AJR Am J Roentgenol. 1992 Nov;159(5):957-60. doi: 10.2214/ajr.159.5.1414806.
Results Reference
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PubMed Identifier
1406819
Citation
Aguayo SM, Miller YE, Waldron JA Jr, Bogin RM, Sunday ME, Staton GW Jr, Beam WR, King TE Jr. Brief report: idiopathic diffuse hyperplasia of pulmonary neuroendocrine cells and airways disease. N Engl J Med. 1992 Oct 29;327(18):1285-8. doi: 10.1056/NEJM199210293271806. No abstract available.
Results Reference
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PubMed Identifier
1519851
Citation
Low RB, Giancola MS, King TE Jr, Chapitis J, Vacek P, Davis GS. Serum and bronchoalveolar lavage of N-terminal type III procollagen peptides in idiopathic pulmonary fibrosis. Am Rev Respir Dis. 1992 Sep;146(3):701-6. doi: 10.1164/ajrccm/146.3.701.
Results Reference
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PubMed Identifier
1503007
Citation
Lynch DA, Rose CS, Way D, King TE Jr. Hypersensitivity pneumonitis: sensitivity of high-resolution CT in a population-based study. AJR Am J Roentgenol. 1992 Sep;159(3):469-72. doi: 10.2214/ajr.159.3.1503007.
Results Reference
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PubMed Identifier
1501266
Citation
King TE Jr, Mortenson RL. Bronchoalveolar lavage in patients with connective tissue disease. J Thorac Imaging. 1992 Jun;7(3):26-48. doi: 10.1097/00005382-199206000-00005.
Results Reference
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PubMed Identifier
1623812
Citation
King TE Jr, Mortenson RL. Cryptogenic organizing pneumonitis. The North American experience. Chest. 1992 Jul;102(1 Suppl):8S-13S.
Results Reference
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PubMed Identifier
1718192
Citation
Cherniack RM, Colby TV, Flint A, Thurlbeck WM, Waldron J, Ackerson L, King TE Jr. Quantitative assessment of lung pathology in idiopathic pulmonary fibrosis. The BAL Cooperative Group Steering Committee. Am Rev Respir Dis. 1991 Oct;144(4):892-900. doi: 10.1164/ajrccm/144.4.892.
Results Reference
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PubMed Identifier
1752942
Citation
Carre PC, Mortenson RL, King TE Jr, Noble PW, Sable CL, Riches DW. Increased expression of the interleukin-8 gene by alveolar macrophages in idiopathic pulmonary fibrosis. A potential mechanism for the recruitment and activation of neutrophils in lung fibrosis. J Clin Invest. 1991 Dec;88(6):1802-10. doi: 10.1172/JCI115501.
Results Reference
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PubMed Identifier
1952439
Citation
Hanley ME, King TE Jr, Schwarz MI, Watters LC, Shen AS, Cherniack RM. The impact of smoking on mechanical properties of the lungs in idiopathic pulmonary fibrosis and sarcoidosis. Am Rev Respir Dis. 1991 Nov;144(5):1102-6. doi: 10.1164/ajrccm/144.5.1102.
Results Reference
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PubMed Identifier
1906922
Citation
Alford CE, King TE Jr, Campbell PA. Role of transferrin, transferrin receptors, and iron in macrophage listericidal activity. J Exp Med. 1991 Aug 1;174(2):459-66. doi: 10.1084/jem.174.2.459.
Results Reference
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PubMed Identifier
1898843
Citation
Shaw RJ, Benedict SH, Clark RA, King TE Jr. Pathogenesis of pulmonary fibrosis in interstitial lung disease. Alveolar macrophage PDGF(B) gene activation and up-regulation by interferon gamma. Am Rev Respir Dis. 1991 Jan;143(1):167-73. doi: 10.1164/ajrccm/143.1.167.
Results Reference
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PubMed Identifier
2064123
Citation
McCormack FX, King TE Jr, Voelker DR, Robinson PC, Mason RJ. Idiopathic pulmonary fibrosis. Abnormalities in the bronchoalveolar lavage content of surfactant protein A. Am Rev Respir Dis. 1991 Jul;144(1):160-6. doi: 10.1164/ajrccm/144.1.160.
Results Reference
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PubMed Identifier
2060352
Citation
King TE Jr. Diagnostic advances in idiopathic pulmonary fibrosis. Chest. 1991 Jul;100(1):238-41. doi: 10.1378/chest.100.1.238. No abstract available.
Results Reference
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PubMed Identifier
2183601
Citation
Panos RJ, Mortenson RL, Niccoli SA, King TE Jr. Clinical deterioration in patients with idiopathic pulmonary fibrosis: causes and assessment. Am J Med. 1990 Apr;88(4):396-404. doi: 10.1016/0002-9343(90)90495-y.
Results Reference
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PubMed Identifier
2394833
Citation
Aguayo SM, King TE Jr, Waldron JA Jr, Sherritt KM, Kane MA, Miller YE. Increased pulmonary neuroendocrine cells with bombesin-like immunoreactivity in adult patients with eosinophilic granuloma. J Clin Invest. 1990 Sep;86(3):838-44. doi: 10.1172/JCI114782.
Results Reference
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PubMed Identifier
2382908
Citation
Buschman DL, Waldron JA Jr, King TE Jr. Churg-Strauss pulmonary vasculitis. High-resolution computed tomography scanning and pathologic findings. Am Rev Respir Dis. 1990 Aug;142(2):458-61. doi: 10.1164/ajrccm/142.2.458.
Results Reference
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PubMed Identifier
9316504
Citation
Martinez JA, King TE Jr, Brown K, Jennings CA, Borish L, Mortenson RL, Khan TZ, Bost TW, Riches DW. Increased expression of the interleukin-10 gene by alveolar macrophages in interstitial lung disease. Am J Physiol. 1997 Sep;273(3 Pt 1):L676-83. doi: 10.1152/ajplung.1997.273.3.L676.
Results Reference
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PubMed Identifier
9116994
Citation
Jennings CA, King TE Jr, Tuder R, Cherniack RM, Schwarz MI. Diffuse alveolar hemorrhage with underlying isolated, pauciimmune pulmonary capillaritis. Am J Respir Crit Care Med. 1997 Mar;155(3):1101-9. doi: 10.1164/ajrccm.155.3.9116994.
Results Reference
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PubMed Identifier
9116980
Citation
Tomioka R, King TE Jr. Gold-induced pulmonary disease: clinical features, outcome, and differentiation from rheumatoid lung disease. Am J Respir Crit Care Med. 1997 Mar;155(3):1011-20. doi: 10.1164/ajrccm.155.3.9116980.
Results Reference
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PubMed Identifier
8952537
Citation
Inoue Y, King TE Jr, Tinkle SS, Dockstader K, Newman LS. Human mast cell basic fibroblast growth factor in pulmonary fibrotic disorders. Am J Pathol. 1996 Dec;149(6):2037-54.
Results Reference
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PubMed Identifier
8616568
Citation
Crausman RS, Jennings CA, Mortenson RL, Ackerson LM, Irvin CG, King TE Jr. Lymphangioleiomyomatosis: the pathophysiology of diminished exercise capacity. Am J Respir Crit Care Med. 1996 Apr;153(4 Pt 1):1368-76. doi: 10.1164/ajrccm.153.4.8616568.
Results Reference
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PubMed Identifier
8756828
Citation
Fitzgerald JE, King TE Jr, Lynch DA, Tuder RM, Schwarz MI. Diffuse panbronchiolitis in the United States. Am J Respir Crit Care Med. 1996 Aug;154(2 Pt 1):497-503. doi: 10.1164/ajrccm.154.2.8756828.
Results Reference
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PubMed Identifier
8542154
Citation
Crausman RS, Jennings CA, Tuder RM, Ackerson LM, Irvin CG, King TE Jr. Pulmonary histiocytosis X: pulmonary function and exercise pathophysiology. Am J Respir Crit Care Med. 1996 Jan;153(1):426-35. doi: 10.1164/ajrccm.153.1.8542154.
Results Reference
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PubMed Identifier
8520787
Citation
Bernstein SM, Newell JD Jr, Adamczyk D, Mortenson RL, King TE Jr, Lynch DA. How common are renal angiomyolipomas in patients with pulmonary lymphangiomyomatosis? Am J Respir Crit Care Med. 1995 Dec;152(6 Pt 1):2138-43. doi: 10.1164/ajrccm.152.6.8520787.
Results Reference
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PubMed Identifier
7582311
Citation
Ohta K, Mortenson RL, Clark RA, Hirose N, King TE Jr. Immunohistochemical identification and characterization of smooth muscle-like cells in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 1995 Nov;152(5 Pt 1):1659-65. doi: 10.1164/ajrccm.152.5.7582311.
Results Reference
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PubMed Identifier
7676971
Citation
Lynch DA, Newell JD, Logan PM, King TE Jr, Muller NL. Can CT distinguish hypersensitivity pneumonitis from idiopathic pulmonary fibrosis? AJR Am J Roentgenol. 1995 Oct;165(4):807-11. doi: 10.2214/ajr.165.4.7676971.
Results Reference
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PubMed Identifier
7633738
Citation
McCormack FX, King TE Jr, Bucher BL, Nielsen L, Mason RJ. Surfactant protein A predicts survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 1995 Aug;152(2):751-9. doi: 10.1164/ajrccm.152.2.7633738. Erratum In: Am J Respir Crit Care Med 1995 Oct;152(4 Pt 1):1425. McCormac FX [corrected to McCormack FX].
Results Reference
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Idiopathic Pulmonary Fibrosis--Pathogenesis and Staging - SCOR in Occupational and Immunological Lung Diseases
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