Journal article
Safety and Tolerability of Comprehensive Research Bronchoscopy in Chronic Obstructive Pulmonary Disease. Results from the SPIROMICS Bronchoscopy Substudy
Annals of the American Thoracic Society, Vol.16(4), pp.439-446
04/2019
DOI: 10.1513/AnnalsATS.201807-441OC
PMCID: PMC6441692
PMID: 30653926
Abstract
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.
To evaluate the safety and tolerability of a comprehensive research bronchoscopy procedure suitable for multicenter trials and to identify factors associated with adverse events.
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.
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.
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.
Details
- Title: Subtitle
- Safety and Tolerability of Comprehensive Research Bronchoscopy in Chronic Obstructive Pulmonary Disease. Results from the SPIROMICS Bronchoscopy Substudy
- Creators
- J Michael Wells - Birmingham VA Medical CenterDouglas A Arenberg - University of Michigan–Ann ArborIgor Barjaktarevic - University of California, Los AngelesSurya P Bhatt - University of Alabama at BirminghamRussell P Bowler - University of Colorado DenverStephanie A Christenson - University of California, San FranciscoDavid J Couper - University of North Carolina at Chapel HillMark T Dransfield - University of Alabama at BirminghamMeiLan K Han - University of Michigan–Ann ArborEric A Hoffman - University of IowaRobert J Kaner - Cornell UniversityVictor Kim - Temple UniversityEric Kleerup - Wake Forest UniversityFernando J Martinez - Cornell UniversityWendy C Moore - Wake Forest UniversitySarah L O'Beirne - 11 Departments of Medicine and Genetic Medicine, Weill Cornell Medicine, New York, New YorkRobert Paine III - Lake City VA Medical CenterNirupama Putcha - Johns Hopkins UniversitySanjeev M Raman - University of UtahR Graham Barr - Columbia UniversityStephen I Rennard - University of Nebraska Medical CenterPrescott G Woodruff - University of California, San FranciscoJeffrey L Curtis - University of Michigan–Ann Arbor
- Resource Type
- Journal article
- Publication Details
- Annals of the American Thoracic Society, Vol.16(4), pp.439-446
- DOI
- 10.1513/AnnalsATS.201807-441OC
- PMID
- 30653926
- PMCID
- PMC6441692
- ISSN
- 2325-6621
- eISSN
- 2325-6621
- Grant note
- HHSN268200900017C / NHLBI NIH HHS K24 HL140108 / NHLBI NIH HHS HHSN268200900019C / NHLBI NIH HHS HHSN268200900020C / NHLBI NIH HHS U24 HL141762 / NHLBI NIH HHS U01 HL137880 / NHLBI NIH HHS HHSN268200900015C / NHLBI NIH HHS I01 CX000911 / CSRD VA HHSN268200900013C / NHLBI NIH HHS K24 HL137013 / NHLBI NIH HHS HHSN268200900016C / NHLBI NIH HHS K08 HL123940 / NHLBI NIH HHS HHSN268200900018C / NHLBI NIH HHS HHSN268200900014C / NHLBI NIH HHS S10 OD018526 / NIH HHS K23 HL123778 / NHLBI NIH HHS HHSN268200900009C / WHI NIH HHS P30 DK054759 / NIDDK NIH HHS
- Language
- English
- Date published
- 04/2019
- Academic Unit
- Roy J. Carver Department of Biomedical Engineering; Radiology; Internal Medicine
- Record Identifier
- 9984318816802771
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