Safety and Tolerability of Comprehensive Research Bronchoscopy in Chronic Obstructive Pulmonary Disease. Results from the SPIROMICS Bronchoscopy Substudy
Year: 2019
Type: article
Abstract: RATIONALE: There is an unmet need to investigate the lower airways in chronic obstructive pulmonary disease (COPD) to define pathogenesis and to identify potential markers to accelerate therapeutic development. Although bronchoscopy is well established to sample airways in various conditions, a comprehensive COPD research protocol has yet to be published. OBJECTIVES: To evaluate the safety and tolerability of a comprehensive research bronchoscopy procedure suitable for multicenter trials and to identify factors associated with adverse events. METHODS: We report the detailed methodology used to conduct the bronchoscopy used in SPIROMICS (the Subpopulations and Intermediate Outcome Measures in COPD Study). The protocol entailed collection of tongue scrapings and oral rinses as well as bronchoscopy with airway inspection, bronchoalveolar lavage (BAL), protected brushings, and endobronchial biopsies. Visual airway characteristics were graded on a scale of 0 (normal appearance) to 3 (severe abnormality) in four domains: erythema, edema, secretions, and friability. Adverse events were defined as events requiring intervention. Logistic regression modeling assessed associations between adverse event occurrence and key variables. RESULTS: We enrolled 215 participants. They were 61 ± 9 years old, 71% were white, 53% were male, and post-bronchodilator forced expiratory volume in 1 second was 89 ± 19% predicted. Self-reported asthma was present in 22% of bronchoscopy participants. Oral samples were obtained in greater than or equal to 99% of participants. Airway characteristics were recorded in 99% and were most often characterized as free of edema (61.9%). Less than 50% reported secretions, friability, or erythema. BAL yielded 111 ± 57 ml (50%) of the 223 ± 65 ml of infusate, brushes were completed in 98%, and endobronchial biopsies were performed in 82% of procedures. Adverse events requiring intervention occurred in 14 (6.7%) of 208 bronchoscopies. In logistic regression models, female sex (risk ratio [RR], 1.10; 95% confidence interval [CI], 1.02-1.19), self-reported asthma (RR, 1.17; 95% CI, 1.02-1.34), bronchodilator reversibility (RR, 1.17; 95% CI, 1.04-1.32), COPD (RR, 1.10; 95% CI, 1.02-1.20), forced expiratory volume in 1 second (RR, 0.97; 95% CI, 0.95-0.99), and secretions (RR, 1.85; 1.08-3.16) or friability (RR, 1.64; 95% CI, 1.04-2.57) observed during bronchoscopy were associated with adverse events. CONCLUSIONS: A research bronchoscopy procedure that includes oral sampling, BAL, endobronchial biopsy, and brushing can be safely performed. Airway characteristics during bronchoscopy, demographics, asthma or COPD, and lung function may convey increased risk for procedure-related events necessitating intervention.
Authors: J. Michael Wells, Douglas A. Arenberg, Igor Barjaktarevic, Surya P. Bhatt, Russell P. Bowler, Stephanie A. Christenson, David J. Couper, Mark T. Dransfield, MeiLan K. Han, Eric A. Hoffman, Robert J. Kaner, Victor Kim, Eric Kleerup, Fernando J. Martinez, Wendy C. Moore, Sarah L. O’Beirne, Robert Paine, Nirupama Putcha, Sanjeev M. Raman, R. Graham Barr, Stephen I. Rennard, Prescott G. Woodruff, Jeffrey L. Curtis
Institutions: University of Alabama at Birmingham, Birmingham VA Medical Center, University of Michigan, Michigan Medicine, University of California, Los Angeles, National Jewish Health, University of Colorado Denver, University of California, San Francisco, University of North Carolina at Chapel Hill, University of Iowa, Weill Cornell Medicine, Temple University, Wake Forest University, University of Utah, VA Salt Lake City Healthcare System, Lake City VA Medical Center, Johns Hopkins University, Columbia University, AstraZeneca (United Kingdom), University of Nebraska Medical Center, VA Ann Arbor Healthcare System
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: green
Awards: G1553802061, G2099663897, G2212190077, G2331765193, G2847413391, G3027037974, G336615015, G3868091120, G3999916299, G4578545918, G4621512325, G4671684786, G4749522346, G4975107759, UAB Mentoring Program in COPD Patient Oriented Research, G5195001291, Identifying the Th2 endotype in COPD: clinical and pathologic implications, G5434367891, G5510456481, G6856928483, G7206313631, G7916689590, G87279447, G8837091488, Ultra-low Dose, High Speed, High Resolution, Multispectral, Multi-Source MDCT Sca, G8957911378, G9000258051, Mentoring Research in Precision Medicine for Lung Disease, Precision Medicine Center for Cystic Fibrosis
OpenAlex ID: W2934656642