Safety and Tolerability of Comprehensive Research Bronchoscopy in Chronic Obstructive Pulmonary Disease. Results from the SPIROMICS Bronchoscopy Substudy.

TitleSafety and Tolerability of Comprehensive Research Bronchoscopy in Chronic Obstructive Pulmonary Disease. Results from the SPIROMICS Bronchoscopy Substudy.
Publication TypePublication
Year2019
AuthorsJ Wells M, Arenberg DA, Barjaktarevic I, Bhatt SP, Bowler RP, Christenson SA, Couper DJ, Dransfield MT, Han MK, Hoffman EA, Kaner RJ, Kim V, Kleerup E, Martinez FJ, Moore WC, O'Beirne SL, Paine R, Putcha N, Raman SM, R Barr G, Rennard SI, Woodruff PG, Curtis JL
JournalAnn Am Thorac Soc
Volume16
Issue4
Pagination439-446
Date Published2019 04
ISSN2325-6621
KeywordsAged, asthma, Biopsy, Bronchi, Bronchoalveolar Lavage, Bronchoscopy, Chest Pain, Cohort Studies, Comorbidity, DYSPNEA, Female, Forced Expiratory Volume, Humans, Logistic Models, Male, Middle Aged, Pulmonary Disease, Chronic Obstructive, United States
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.

DOI10.1513/AnnalsATS.201807-441OC
Alternate JournalAnn Am Thorac Soc
PubMed ID30653926
PubMed Central IDPMC6441692
Grant ListU24 HL141762 / HL / NHLBI NIH HHS / United States
S10 OD018526 / OD / NIH HHS / United States
K24 HL140108 / HL / NHLBI NIH HHS / United States
K08 HL123940 / HL / NHLBI NIH HHS / United States
I01 CX000911 / CX / CSRD VA / United States
U01 HL137880 / HL / NHLBI NIH HHS / United States
P30 DK054759 / DK / NIDDK NIH HHS / United States
K23 HL123778 / HL / NHLBI NIH HHS / United States
K24 HL137013 / HL / NHLBI NIH HHS / United States
MS#: 
MS122
Manuscript Full Title: 
Safety and Tolerability of Comprehensive Research Bronchoscopy in Chronic Obstructive Pulmonary Disease. Results from the SPIROMICS Bronchoscopy Substudy.
Manuscript Lead/Corresponding Author Affiliation: 
Clinical Center: Birmingham (University of Alabama at Birmingham)
ECI: 
Manuscript Status: 
Published and Public