Advances in Controlled Clinical Inhalation Studies PDF
Preview Advances in Controlled Clinical Inhalation Studies
Advances in Controlled Clinical Inhalation Studies ILSI Monographs Carcinogenicity: The Design, Analysis, and Interpretation of Long-Term Animal Studies H.C. Grice and J.L. Ciminera, Editors 1988.279 pp. ISBN 0-387-18301-9 Inhalation Toxicology: The Design and Interpretation of Inhalation Studies and Their Use in Risk Assessment U. Mohr, Editor-in-Chief D.L. Dungworth, G. Kimmerle, J. Lewkowski, R.O. McClellan, W. StOber 1988.318 pp. ISBN 0-387-17822-8 Radionuclides in the Food Chain M.D. Carter, Editor-in-Chief J.H. Harley, G.D. Schmidt, G. Silini, Editors 1988.518 pp. ISBN 0-387-19511-4 Assessment of Inhalation Hazards: Integration and Extrapolation Using Diverse Data U. Mohr, Editor-in-Chief D.Y. Bates, D.L. Dungworth, P.N. Lee, R.O. McClellan, EJ.C. Roe, Editors 1989. 382 pp. ISBN 3-540-50952-6 Advances in Controlled Clinical Inhalation Studies U. Mohr, Editor-in-Chief D.Y. Bates, H. Fabel, M.J. Utell, Editors 1993.442 pp. ISBN 3-540-54958-7 ILSI Sponsored by the International MONOGRAPHS Life Sciences Institute U. Mohr Editor-in-Chief Advances in Controlled Clinical Inhalation Studies D.V. Bates H. Fabel M.J. Utell Editors Springer-Verlag Berlin Heidelberg New York London Paris Tokyo Hong Kong Barcelona Budapest Ulrich Mohr, Prof. Dr. med. Medizinische Hochschule Hannover, Institut fiir Experimentelle Pathologie, Konstanty-Gutschow-StraBe 8, 3000 Hannover 61, FRG David V. Bates, M.D., ER.C.P., ER.C.P.C., EA.C.P., ER.S.C. University of British Columbia, Dept. Health and Epidemiology, 5804 Fairview Crescent, Mather Building, Vancouver, BC, Canada V6T lW5 H. Fabel, Prof. Dr. med. Medizinische Hochschule Hannover, Abteilung Pneumologie, Konstanty-Gutschow StraBe 8, 3000 Hannover 61, FRG Mark J. Utell, M.D. Professor of Medicine and Environmental Medicine, Pulmonary and Critical Care Unit, University of Rochester Medical Center, 601 Elmwood Avenue, Rochester, NY 14642, USA With 101 Figures ISBN-13:978-3-642-77178-1 e-ISBN-13:978-3-642-77176-7 DOl: 10.1007/978-3-642-77176-7 This work is subject to copyright. All rights are reserved, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilm or in any other way, and storage in data banks. Duplication of this publication or parts thereof is permitted only under the provisions of the German Copyright Law of September 9, 1965, in its current version, and permission for use must always be obtained from Springer-Verlag. Violations are liable for prosecution under the German Copyright Law. © Springer-Verlag Berlin Heidelberg 1993 Softcover reprint of the hardcover 1st edition 1993 The use of general descriptive names, registered names, trademarks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. Product liability: The publishers cannot guarantee the accuracy of any information about dosage and application contained in this book. In every individual case the user must check such information by consulting the relevant literature. Typesetting: Best-set Typesetter Ltd., Hong Kong 23/3145-543210 - Printed on acid-free paper Series Foreword The International Life Sciences Institute (ILSI), a nonprofit, public foundation, was established in 1978 to advance the sciences of nutrition, toxicology, and food safety. ILSI promotes the resolution of health and safety issues in these areas by sponsoring research, conferences, publications, and educational programs. Through ILSI's programs, scientists from government, academia, and industry unite their efforts to resolve issues of critical importance to the public. As part of its commitment to understanding and resolving health and safety issues, ILSI is pleased to sponsor this series of monographs that consolidates new scientific knowledge, defines research needs, and provides a background for the effective application of scientific advances in toxicology and food safety. Alex Malaspina President International Life Sciences Institute Contents Part I. Symposium Presentation .......................................................................... . The Emergence of Controlled Human Exposure Studies (D.V. BATES) .................................................................................................................. 3 Section 1. The Outdoor Environment in Europe .............................................. 9 Trend of Air Quality in North Rhine-Westphalia (Rhine-Ruhr Area) During the Past 20 Years (M. BUCK) ..................................................................................................................... 9 Air Pollution in the Former German Democratic Republic: Consequences for Health Control (B. THRIENE) .................................................................................................................. 21 The Outdoor Environment in North America ................................................... 31 Exposure to Oxidant Gases and Acidic Particles in the United States (P.I. LIOy) ..................................................................................................................... 31 Section 2. Indoor Air: Home and Workplace .................................................... .43 Investigation of Indoor Air Pollution Sources in Climate Chambers: Emissions from Textile Floor Coverings (S. SOLLINGER and K. LEVSEN) ...................................................................................... 43 Dust Measurements at Workplaces: State of the Art and Future Demands (W. KOCH) ..................................................................................................................... 57 Health Effects of Indoor Air Exposures (M. LIPPMANN) ............................................................................................................... 69 Inhalation Studies in Investigation of the Sick Building Syndrome (L. M0LHAVE) ................................................................................................................ 85 VIII Contents Section 3. Assessing Personal Exposure ........................................................... 95 Personal Exposure Assessment: Implications for Clinical Studies of Inhaled Pollutants (J.M. SAMET and W.E. LAMBERT) ............................................................................... 95 Regional Deposition of Inhaled Particles in the Human Respiratory Tract (J. HEYDER) .................................................................................................................. 103 Calculation of Acid Aerosol Dose (T.Y. LARSON, Q.S. HANLEY, J.Q. KOENIG, and O. BERNSTEIN) ................................... 109 Section 4. Clinical Inhalation Methodology ................................................... 123 Generation of Complex Aerosols (W. HOLLANDER) .......................................................................................................... 123 Assessment of Ambient Exposures and Their Effects on Health in Chambers (J.D. HACKNEY and W.S. LINN) .................................................................................. 135 Susceptible Populations: Lessons from Controlled Exposure Studies of Inhaled Pollutants (M.J. UTELL) ............................................................................................................... 143 Inhalation of Pollutants and Pollutant Mixtures in Subjects with Bronchial Hyperresponsiveness (H. MAGNUSSEN and R. JORRES) .................................................................................. 151 Section 5. New Methodologies ............................................................................. 159 Controlled Clinical Inhalation Studies with Environmental Air Pollutants at Concentrations Commonly Found in the Ambient Air (T.O.F. WAGNER, WH.T. SCHiiRMANN, and H. FABEL) ............................................... 159 Time- and Dose-Dependent Cellular and Biochemical Changes in Response to Ozone Exposure (H.S. KOREN, S. BECKER, P.A. BROMBERG, and R.B. DEVLIN) .................................... 169 Regeneration, Differentiation, and Neoplastic Transformation of Type II Alveolar Epithelial Cells (K.-U. THIEDEMANN, I. PAULINI, N. LUTHE, A. KREFr, U. ABEL, U. HEINRICH, U. GLASER, and U. MOHR) .......................................................................................... 185 Infectivity Models in Clinical Inhalation Studies (M.W. FRAMPfON) ....................................................................................................... 199 Does the Pulmonary Surfactant System Yield Meaningful Parameters in Inhalation Toxicity Studies? A Review (R. KLINGEBIEL AND U. HEINRICH) ............................................................................... 209 Contents IX New Approaches to Evaluating the Pulmonary Effects of Controlled Inhalation Exposures in Human Volunteers (P.A. BROMBERG) ......................................................................................................... 235 Section 6. Clinical Data and Regulatory Decisions ....................................... 247 Meta-analysis and "Effective Dose" Revisited (M.J. HAZUCHA.) ........................................................................................................... 247 Regulating Indoor Air (B. SEIFERT) ................................................................................................................. 257 Perspective on the Regulator's Need for Future Clinical Studies (D.J. MCKEE) .............................................................................................................. 269 Part II. Poster Presentations ................................................................................ 283 Use of Questionnaires for Assessment of Exposure to Airborne Pollutants (N.C.G. FREEMAN and P.I. LIOY) ................................................................................ 285 Disorders in the Olfactory Function and Injury of the Upper Airways of Exposed Workers in Copper-Producing Works (N. GINCHEVA andA. SAVOV) ....................................................................................... 297 Elevated Bioaerosols in Manufactured/Conventional Homes (C.T. HOWLETT, JR., L.R. NEWTON, T.N. VIRE, and J.J. TICE IV) ............................... 303 Single-Breath Bolus Exposure for Noninvasive Determination of Ozone Dose Distribution (S.c. Hu, J.S. ULTMAN, and A. BEN-JEBRIA) ............................................................... 309 Problems of Regulating Outdoor Ozone Levels (A.D. KApPOs, G. Koss, I. TESSERAUX, and P. BRUCKMANN) ....................................... 317 Inhalation Studies with Airborne Particulates in Rodents: Cytotoxic and Genotoxic Effects on Alveolar Macrophages and Bone Marrow Cells (A. KrELL, W. HADNAGY, N.H. SEEMAYER, H. BEHRENDT, and R. TOMINGAs) ............. 323 Assessment of Pollutant-Induced Impairment of the Pulmonary Surfactant System by High-Performance Liquid Chromatography (R. KLINGEBIEL, H.D. WINKELER, F. DRENK, and U. HEINRICH) ................................... 337 Assessment of 2,4-Dichlorophenoxyacetic Acid Exposure in the Chemical Industry by Biological Monitoring (D. KNopp, G. RICHTER, M. SKERSWETAT, H. HERMENAU, and E. STOTTMEISTER) ........ 345 Assessment by Aerosol Recovery Technique of Site of Airway Constriction During Intravenous Histamine Challenge (M. MEYER and A. RAHMEL) ....................................................................................... 347 X Contents Attempted Selective Deposition of Aerosols Using Differently Sized Particles in Man (S.P. MOHAMMED, RW. BARBER, and T.W. HIGENBOTTAM) ......................................... 357 Acute Effects of Ambient Ozone in Physically Active Adults (H.-G. MOcKE, U. RANFT, and M.S. ISLAM) ............................................................... 365 Respiratory Injuries in Workers from the Coke Chemical Industry (E. PETRoVA and V. HRISTEVA) ..................................................................................... 373 Aerosol-Derived Airway Dimensions of Dog Lungs: Comparison of Bolus and Single-Breath Techniques (A. RAHMEL, A. SCHWALEN, E. CALZIA, A. HUBER, H. SCHULZ, and M. MEYER) ......... 377 Nonoccupational Exposure to Benzene (G. SCHERER, C. CONZE, J. ANGERER, and F. ADLKOFER) ............................................. 387 Comparative Investigation of Genotoxic and Nongenotoxic Mechanisms and Their Relevance in Carcinogenesis Induced by Airborne Particulates and Automobile Exhaust Particulates (N.H. SEEMAYER, W. HADNAGY, and R TOMINGAS) ..................................................... 393 Gestational Inhalation of Indoor Air Pollution Alters Neonatal Reflex Development and Fetal Hematology (J. SINGH) ..................................................................................................................... 405 Aerosol Deposition Pattern of Technetium-99m-Labeled Fenoterol After Inhalation from Three Devices in Healthy Volunteers (1. WAITZINGER, T. ZIMMERMANN, A. HAMMERMAIER, W. FLEISCHER, G. PABST, AND H. JAEGER) ............................................................................................................ 411 Comparison of Bronchospasmolytic Effects of 200 /-Lg Fenoterol After Inhalation with Respimat and Metered Dose Inhaler (T. ZIMMERMANN, R STECHERT, H. SCHWEISFURTH, and R WETTENGEL) .................... .415 Subject Index ........................................................................................................... 423 Contributors* ABEL, U. 185 HEYDER, J. 103 ADLKOFER, F. 387 HIGENBOTIAM, T.W. 357 ANGERER, J. 387 HOLLANDER, W. 123 HOWLETI, c.T., JR. 303 BARBER, R.W 357 HRISTEVA, V. 373 BATES, D.V. 3 Hu, S.C. 309 BECKER, S. 169 HUBER, A. 377 BEHRENDT,H. 323 BEN-JEBRIA, A. 309 ISLAM, M.S. 365 BERNSTEIN, O. 109 BROMBERG, P.A. 169,235 JAEGER, H. 411 BRUCKMANN, P. 317 JORRES, R. 151 BUCK, M. 9 KAPPaS, A.D. 317 CALZIA, E. 377 KiELL, A. 323 CONZE, C. 387 KLINGEBIEL, R. 209,337 KNopp, D. 345 DEVLIN, R.B. 169 KOCH, W 57 DRENK, F. 327 KOENIG, J.Q. 109 KOREN, H.S. 169 FABEL, H. 159 Koss,G. 317 FLEISCHER, W. 411 KREFT, A. 185 FRAMPTON, M.W. 199 FREEMAN, N.C.G. 285 LAMBERT, W.E. 95 LARSON, T.V. 109 GINCHEVA, N. 297 LEVSEN, K. 43 GLASER, U. 185 LINN, WS. 135 LIOY, P.J. 31, 285 HACKNEY, J.D. 135 LIPPMANN, M. 69 HADNAGY, W 323,393 LUTHE, N. 185 HAMMERMAIER, A. 411 HANLEY, Q.S. 109 MAGNUSSEN, H. 151 HAZUCHA, MJ. 247 MCKEE, DJ. 269 HEINRICH, U. 185, 209, 327 MEYER, M. 347,377 HERMENAU, H. 345 MOHAMMED, S.P. 357 * The numbers after the names refer to the contribution title page, where the author's complete address can be found. Numbers in bold indicate senior authors.
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