Published ahead of print on July 14, 2005, doi:10.1164/rccm.200407-966WS Am. J. Respir. Crit. Care Med., Volume 172, Number 7, October 2005, 807-816 A more recent version of this article appeared on October 1, 2005
Submitted on July 26, 2004 Workshop on Investigative Bronchoprovocation and Bronchoscopy in Airway DiseasesWilliam W Busse1,1 University of Wisconsin-Madison, Madison, WI, USA, 2 University of Miami School of Medicine, Miami, FL, USA, 3 National Institute of Allergy and Infectious Diseases, Bethesda, MD, USA, 4 Division of Lung Disease, National Heart, Lung, and Blood Institute, Bethesda, MD, USA, 5 Washington University School of Medicine, St. Louis, MO, USA, 6 US Food and Drug Administration, Rockville, MD, USA, 7 National Jewish Medical and Research Center, Denver, CO, USA, 8 Yale University School of Medicine, New Haven, CT, USA, 9 Wake Forest University Health Sciences, Winston Salem, NC, USA * To whom correspondence should be addressed. E-mail: reynoldsh{at}mail.nih.gov.
Rationale. Basic and clinical research strategies used for many lung diseases have depended on volunteer subjects undergoing bronchoscopy to establish access to the airways in order to collect biological specimens and tissue, perhaps with added bronchoprovocation in asthma syndromes. These procedures have yielded a wealth of important scientific information. Since the last critical review more than a decade ago, some of the techniques and applications have changed, and untoward events have occurred raising safety concerns and increasing institutional review scrutiny. Objectives and Methods. To reappraise these investigational methods in the context of current knowledge, the National Heart, Lung, and Blood Institute and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health convened a working group to review these procedures used for airway disease research, emphasizing asthma and chronic obstructive pulmonary disease. Main Results. The group reaffirmed the scientific importance of investigative bronchoscopy and bronchoprovocation, even as less invasive technologies evolve. The group also considered the safety of bronchoscopy and bronchoprovocation with methacholine and antigen to be acceptable for volunteer subjects and patients, but stressed the need to monitor this closely and to emphasize proper training of participating medical research personnel. Issues were raised about vulnerable volunteers, especially children who need surrogates for informed consent. Conclusion. This review of investigative bronchoscopy and bronchoprovocation could serve as the basis for future guidelines for the use of these procedures in the United States. Key words: Keywords: Bronchoprovocation, bronchoscopy, airway hyperresponsiveness, methacholine, lidocaine, bronchoalveolar lavage, segmental allergen challenge, endobronchial biopsy, asthma, COPD
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