Asthma and lower airway diseaseSafety of investigative bronchoscopy in the Severe Asthma Research Program
Section snippets
SARP
After establishing standard operating procedures, including a review by an independent data safety monitoring board (DSMB) and approval by the institutional review boards at each site, subjects underwent a comprehensive phenotypic characterization as previously described.12 Briefly, after subjects provided written informed consent, clinical staff administered questionnaires (asthma symptoms, medication use, medical history, and HCU), performed allergen skin prick testing, and performed a
Characteristics of subjects enrolled in bronchoscopy procedures
Between May 2003 and September 2009, 436 subjects underwent investigative bronchoscopy at 9 clinical sites as part of the SARP (see this article’s Table E2 in the Online Repository at www.jacionline.org). In general, the demographics of this subset of subjects with asthma (Table III) reflect those of the entire SARP cohort as previously reported.12 Subjects with asthma in the bronchoscopy cohort were divided into 3 groups for the purposes of this safety analysis: not severe asthma, severe
Discussion
The current study reports our experience with investigative bronchoscopy in a large subset of subjects from the SARP, including 143 subjects with severe asthma who met the American Thoracic Society (ATS) workshop definition of severe asthma, 196 subjects with not severe asthma, and 97 normal controls. The aim of our study was to evaluate prospectively changes in pulmonary function and the frequency of respiratory-related events in subjects with not severe and severe asthma undergoing
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2021, Journal of Allergy and Clinical ImmunologyCitation Excerpt :Four healthy control subjects were excluded for having evidence of positive test results for more than 5 common aeroallergens on ImmunoCAP immunologic testing (Thermo Fisher Scientific, Waltham, Mass). All subjects underwent fiberoptic bronchoscopy with lavage, as previously described.25 BALF samples were collected within 12 hours of subjects' admission to the hospital before medication was issued.
Supported by HL69116, HL69130, HL69155, HL69167, HL69170, HL69174, HL69349, HL091762, M01 RR03186, M01 RR007122-14, 1UL1RR024992, 1UL1RR024989, and 1UL1RR025011.
Disclosure of potential conflict of interest: W. C. Moore receives research support from the NHLBI Severe Asthma Research Program. E. R. Bleecker receives research support from the National Institutes of Health (NIH)/NHLBI/Severe Asthma Research Program. W. W. Busse is on advisory boards for Centocor and Merck; has consultant arrangements with AstraZeneca, Boehringer Ingelheim, Novartis, TEVA, GlaxoSmithKline, Amgen, Prizer, MedImmune, and Genentech; and receives research support from the NIH-NIAID, NIH-NHLBI, Novartis, AstraZeneca, GlaxoSmithKline, MedImmune, and Ception. M. Castro has consultant arrangements with Electrocore, NKTT, Schering, Asthmatx, and Cephalon; is on the advisory board for Genentech; is a speaker for AstraZeneca, Boerhinger-Ingelheim, Pfizer, Merck, and GlaxoSmithKline; receives research support from Asthmatx, Amgen, Ception, Genentech, MedImmune, Merck, Novartis, the NIH, and GlaxoSmithKline; and receives royalties from Elsevier. K. F. Chung receives research support from the NIH. S. C. Erzurum receives research support from Asthmatx. R. A. Dweik receives research support from the NIH and the state of Ohio. B. Gaston is a primary shareholder in Respiratory Research, Inc, and receives research support from the NIH. E. Israel has consultant arrangements with Abbott, Amgen, Cowen & Co, GlaxoSmithKline, Icagen, MedImmune, Merck, NewMentor, NKT Therapeutics, Ono Pharmaceuticals US, Pulmatrix, Schering Plough, and Teva Specialty Pharmaceuticals and receives research support from Aerovance, Amgen, Ception Therapeutics, Genentech, Icagen, MedImmune, the NIH, and Novartis. M. L. Mayse has consultant arrangements with Asthmatx. S. P. Peters receives research support from the NIH/NHLBI/Severe Asthma Research Program. N. N. Jarjour has consultant arrangements with Asthmatx and Genentech and receives research support from GlaxoSmithKline, Merck, and MedImmune. The rest of the authors have declared that they have no conflict of interest.
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The Severe Asthma Research Program is a multicenter asthma research group funded by the National Heart, Lung, and Blood Institute (NHLBI) and consisting of the following contributors (∗Principal Investigators): Brigham & Women’s Hospital—Elliot Israel,∗ Bruce D. Levy, Gautham Marigowda, Michael E. Wechsler; Cleveland Clinic—Serpil C. Erzurum,∗ Raed A. Dweik, Suzy A. A. Comhair, Emmea Cleggett-Mattox, Deepa George, Marcelle Baaklini, Daniel Laskowski; Emory University—Anne M. Fitzpatrick, Denise Whitlock, Shanae Wakefield; Imperial College School of Medicine—Kian F. Chung,∗ Mark Hew, Patricia Macedo, Sally Meah, Florence Chow; University of Iowa—Eric Hoffman; University of Pittsburgh—Sally E. Wenzel,∗ Fernando Holgion, Jen Chamberlin; University of Texas–Medical Branch—William J. Calhoun,∗ Bill T. Ameredes; University of Virginia—Benjamin Gaston,∗ W. Gerald Teague,∗ Denise Thompson-Batt; University of Wisconsin—William W. Busse,∗ Nizar Jarjour, Ronald Sorkness, Sean Fain, Erin Billmeyer, Cheri Swenson, Gina Crisafi, Laura Frisque, Dan Polk; Wake Forest University—Eugene R. Bleecker,∗ Deborah Meyers, Wendy Moore, Stephen Peters, Rodolfo M. Pascual, Annette Hastie, Gregory Hawkins, Jeffrey Krings, Regina Smith; Washington University in St Louis—Mario Castro,∗ Leonard Bacharier, Jaime Tarsi; Data Coordinating Center—Douglas Curran-Everett,∗ Ruthie Knowles, Maura Robinson, Lori Silveira; NHLBI—Patricia Noel, Robert Smith.