Safety and tolerability of comprehensive research bronchoscopy in chronic obstructive pulmonary disease results from the SPIROMICS bronchoscopy substudy

J. Michael Wells, Douglas A. Arenberg, Igor Barjaktarevic, Surya P. Bhatt, Russell P. Bowler, Stephanie A. Christenson, David J. Couper, Mark T. Dransfield, Mei Lan 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 & 3 others Stephen I. Rennard, Prescott G. Woodruff, Jeffrey L. Curtis

Research output: Contribution to journalArticle

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 6 9 years old, 71% were white, 53% were male, and post-bronchodilator forced expiratory volume in 1 second was 89 6 19% predicted. Selfreported 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 6 57 ml (50%) of the 223 6 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.

Original languageEnglish (US)
Pages (from-to)439-446
Number of pages8
JournalAnnals of the American Thoracic Society
Volume16
Issue number4
DOIs
StatePublished - Apr 1 2019

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Bronchoscopy
Chronic Obstructive Pulmonary Disease
Outcome Assessment (Health Care)
Safety
Odds Ratio
Research
Confidence Intervals
Bronchoalveolar Lavage
Asthma
Logistic Models
Bronchodilator Agents
Forced Expiratory Volume
Erythema
Biopsy
Edema
Sex Ratio
Tongue
Multicenter Studies
Demography
Lung

Keywords

  • Bronchoscopy
  • Chronic obstructive pulmonary disease
  • Methodology/protocol
  • Safety

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

Safety and tolerability of comprehensive research bronchoscopy in chronic obstructive pulmonary disease results from the SPIROMICS bronchoscopy substudy. / Michael Wells, J.; Arenberg, Douglas A.; Barjaktarevic, Igor; Bhatt, Surya P.; Bowler, Russell P.; Christenson, Stephanie A.; Couper, David J.; Dransfield, Mark T.; Han, Mei Lan K.; Hoffman, Eric A.; Kaner, Robert J.; Kim, Victor; Kleerup, Eric; Martinez, Fernando J.; Moore, Wendy C.; O'Beirne, Sarah L.; Paine, Robert; Putcha, Nirupama; Raman, Sanjeev M.; Graham Barr, R.; Rennard, Stephen I.; Woodruff, Prescott G.; Curtis, Jeffrey L.

In: Annals of the American Thoracic Society, Vol. 16, No. 4, 01.04.2019, p. 439-446.

Research output: Contribution to journalArticle

Michael Wells, J, Arenberg, DA, Barjaktarevic, I, Bhatt, SP, Bowler, RP, Christenson, SA, Couper, DJ, Dransfield, MT, Han, MLK, Hoffman, EA, Kaner, RJ, Kim, V, Kleerup, E, Martinez, FJ, Moore, WC, O'Beirne, SL, Paine, R, Putcha, N, Raman, SM, Graham Barr, R, Rennard, SI, Woodruff, PG & Curtis, JL 2019, '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, no. 4, pp. 439-446. https://doi.org/10.1513/AnnalsATS.201807-441OC
Michael Wells, J. ; Arenberg, Douglas A. ; Barjaktarevic, Igor ; Bhatt, Surya P. ; Bowler, Russell P. ; Christenson, Stephanie A. ; Couper, David J. ; Dransfield, Mark T. ; Han, Mei Lan K. ; Hoffman, Eric A. ; Kaner, Robert J. ; Kim, Victor ; Kleerup, Eric ; Martinez, Fernando J. ; Moore, Wendy C. ; O'Beirne, Sarah L. ; Paine, Robert ; Putcha, Nirupama ; Raman, Sanjeev M. ; Graham Barr, R. ; Rennard, Stephen I. ; Woodruff, Prescott G. ; Curtis, Jeffrey L. / Safety and tolerability of comprehensive research bronchoscopy in chronic obstructive pulmonary disease results from the SPIROMICS bronchoscopy substudy. In: Annals of the American Thoracic Society. 2019 ; Vol. 16, No. 4. pp. 439-446.
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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 6 9 years old, 71{\%} were white, 53{\%} were male, and post-bronchodilator forced expiratory volume in 1 second was 89 6 19{\%} predicted. Selfreported 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 6 57 ml (50{\%}) of the 223 6 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.",
keywords = "Bronchoscopy, Chronic obstructive pulmonary disease, Methodology/protocol, Safety",
author = "{Michael Wells}, J. and Arenberg, {Douglas A.} and Igor Barjaktarevic and Bhatt, {Surya P.} and Bowler, {Russell P.} and Christenson, {Stephanie A.} and Couper, {David J.} and Dransfield, {Mark T.} and Han, {Mei Lan K.} and Hoffman, {Eric A.} and Kaner, {Robert J.} and Victor Kim and Eric Kleerup and Martinez, {Fernando J.} and Moore, {Wendy C.} and O'Beirne, {Sarah L.} and Robert Paine and Nirupama Putcha and Raman, {Sanjeev M.} and {Graham Barr}, R. and Rennard, {Stephen I.} and Woodruff, {Prescott G.} and Curtis, {Jeffrey L.}",
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TY - JOUR

T1 - Safety and tolerability of comprehensive research bronchoscopy in chronic obstructive pulmonary disease results from the SPIROMICS bronchoscopy substudy

AU - Michael Wells, J.

AU - Arenberg, Douglas A.

AU - Barjaktarevic, Igor

AU - Bhatt, Surya P.

AU - Bowler, Russell P.

AU - Christenson, Stephanie A.

AU - Couper, David J.

AU - Dransfield, Mark T.

AU - Han, Mei Lan K.

AU - Hoffman, Eric A.

AU - Kaner, Robert J.

AU - Kim, Victor

AU - Kleerup, Eric

AU - Martinez, Fernando J.

AU - Moore, Wendy C.

AU - O'Beirne, Sarah L.

AU - Paine, Robert

AU - Putcha, Nirupama

AU - Raman, Sanjeev M.

AU - Graham Barr, R.

AU - Rennard, Stephen I.

AU - Woodruff, Prescott G.

AU - Curtis, Jeffrey L.

PY - 2019/4/1

Y1 - 2019/4/1

N2 - 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 6 9 years old, 71% were white, 53% were male, and post-bronchodilator forced expiratory volume in 1 second was 89 6 19% predicted. Selfreported 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 6 57 ml (50%) of the 223 6 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.

AB - 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 6 9 years old, 71% were white, 53% were male, and post-bronchodilator forced expiratory volume in 1 second was 89 6 19% predicted. Selfreported 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 6 57 ml (50%) of the 223 6 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.

KW - Bronchoscopy

KW - Chronic obstructive pulmonary disease

KW - Methodology/protocol

KW - Safety

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