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

Wells, James M.; Bhatt, Surya P.; Bowler, Russell P.; Christenson, Stephanie A.; Couper, David J.; Han, Mei Lan K.; Hoffman, Eric A.; Kaner, Robert J.; Kim, Victor; Kleerup, Eric C.; Martínez, Fernando J.; Moore, Wendy C.; O’Beirne, Sarah L.; Paine, Robert; Putcha, Nirupama; Raman, Sanjeev; Barr, R. Graham; Rennard, Stephen I.; Woodruff, Prescott G.; Curtis, Jeffrey L.

doi:10.1513/annalsats.201807-441oc

Cited by 22 publications

(26 citation statements)

References 41 publications

(50 reference statements)

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“…Nevertheless, we acknowledge that the occurrence of COPD exacerbations may in part have been influenced by the bronchoscopic interventions, which included multiple cryobiopsies. To put this rate into context, an analysis of the SPIROMICS (Subpopulations and Intermediate Outcome Measures in COPD Study) trial demonstrated a 27% rate of respiratory complications after research bronchoscopy performed in patients with COPD ( 26 ).…”

Section: Discussionmentioning

confidence: 99%

Bronchial Rheoplasty for Treatment of Chronic Bronchitis. Twelve-Month Results from a Multicenter Clinical Trial

Valipour

Fernández-Bussy

Ing

et al. 2020

Am J Respir Crit Care Med

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Rationale: Chronic bronchitis (CB) is characterized by productive cough with excessive mucus production, resulting in quality-of-life impairment and increased exacerbation risk. Bronchial rheoplasty uses an endobronchial catheter to apply nonthermal pulsed electrical fields to the airways. Preclinical studies have demonstrated epithelial ablation followed by regeneration of normalized epithelium. Objectives: To evaluate the feasibility, safety, and initial outcomes of bronchial rheoplasty in patients with CB. Methods: Pooled analysis of two separate studies enrolling 30 patients undergoing bilateral bronchial rheoplasty was conducted. Follow-up through 6 months (primary outcome) and 12 months included assessment of adverse events, airway histology, and changes in symptoms using the Chronic Obstructive Pulmonary Disease (COPD) Assessment Test and St. George’s Respiratory Questionnaire (SGRQ). Measurements and Main Results: Bronchial rheoplasty was performed in all 30 patients (63% male; mean [SD] age, 67 [7.4]; mean [SD] postbronchodilator FEV 1 , 65% [21%]; mean [SD] COPD Assessment Test score 25.6 [7.1]; mean [SD] SGRQ score, 59.6 [15.3]). There were no device-related and four procedure-related serious adverse events through 6 months, and there were none thereafter through 12 months. The most frequent nonserious, device- and/or procedure-related event through 6 months was mild hemoptysis in 47% (14 of 30) patients. Histologically, the mean goblet cell hyperplasia score was reduced by a statistically significant amount ( P < 0.001). Significant changes from baseline to 6 months in COPD Assessment Test (mean, −7.9; median, −8.0; P = 0.0002) and SGRQ (mean, −14.6; median, −7.2; P = 0.0002) scores were observed, with similar observations through 12 months. Conclusions: This study provides the first clinical evidence of the feasibility, safety, and initial outcomes of bronchial rheoplasty in symptomatic patients with CB. Clinical trial registered with www.anzctr.org.au (ACTRN 12617000330347) and clinicaltrials.gov (NCT 03107494).

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Section: Discussionmentioning

confidence: 99%

Bronchial Rheoplasty for Treatment of Chronic Bronchitis. Twelve-Month Results from a Multicenter Clinical Trial

Valipour

Fernández-Bussy

Ing

et al. 2020

Am J Respir Crit Care Med

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“…The Subpopulations Intermediate Outcome Measures in COPD Study (SPIROMICS) is a prospective cohort study that has enrolled 2981 subjects across four strata (1) Never smokers (NS), (2) Current or former smokers without COPD (HS), (3) Mild/Moderate COPD, and (4) Severe COPD). Goblet Cell Density (GCD) was measured in 71 subjects in strata 2-4 (current or former smokers with and without COPD) in which endobronchial mucosal biopsies were obtained during the SPIROMICS bronchoscopy substudy 13 . Methods of measuring GCD were performed as previously described 8 .…”

Section: Methodsmentioning

confidence: 99%

Current smoking with or without chronic bronchitis is independently associated with goblet cell hyperplasia in healthy smokers and COPD subjects

Kim

Jeong

Zhao

et al. 2020

Sci Rep

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COPD, chronic bronchitis (CB) and active smoking have all been associated with goblet cell hyperplasia (GCH) in small studies. Active smoking is strongly associated with CB, but there is a disconnect between CB clinical symptoms and pathology. Chronic cough and sputum production poorly correlate with the presence of GCH or COPD. We hypothesized that the primary determinant of GCH in ever smokers with or without airflow obstruction is active smoking. Goblet Cell Density (GCD) was measured in 71 current or former smokers [32 subjects without COPD and 39 COPD subjects]. Endobronchial mucosal biopsies were stained with Periodic Acid Schiff-Alcian Blue, and GCD was measured as number of goblet cells/mm basement membrane. GCD was divided into tertiles based on log10 transformed values. Log10GCD was greater in current smokers compared to former smokers. Those with classically defined CB or SGRQ defined CB had a greater log10 GCD compared to those without CB. Current smoking was independently associated with tertile 3 (high log10GCD) whereas CB was not in multivariable regression when adjusting for lung function and demographics. These results suggest that GCH is induced by active smoke exposure and does not necessarily correlate with the clinical symptoms of CB.

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“…BAL was performed in the right middle lobe and lingula by instilling two aliquots of 40 mL and one aliquot of 50 mL per lobe (260 mL total volume), after excluding an initial airway wash sample. Unfiltered BALF fluid was collected into a sterilized beaker or in multiple 50 mL conical tubes on ice, then centrifuged at 300 x g for 5 min and the supernatant aliquoted into 1 mL aliquots for storage at −80 °C, representing one BALF sample per patient as described previously 63,64 . Because no research plasma samples were obtained in the bronchoscopy sub-study, the plasma biomarkers, including ferritin, in this analysis were measured from the baseline visit samples.…”

Section: Discussionmentioning

confidence: 99%

Increased airway iron parameters and risk for exacerbation in COPD: an analysis from SPIROMICS

Zhang

Oromendia

Kikkers

et al. 2020

Sci Rep

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Levels of iron and iron-related proteins including ferritin are higher in the lung tissue and lavage fluid of individuals with chronic obstructive pulmonary disease (COPD), when compared to healthy controls. Whether more iron in the extracellular milieu of the lung associates with distinct clinical phenotypes of COPD, including increased exacerbation susceptibility, is unknown. We measured iron and ferritin levels in the bronchoalveolar lavage fluid (BALF) of participants enrolled in the SubPopulations and InteRmediate Outcome Measures In COPD (SPIROMICS) bronchoscopy sub-study (n = 195). BALF Iron parameters were compared to systemic markers of iron availability and tested for association with FEV 1 % predicted and exacerbation frequency. Exacerbations were modelled using a zero-inflated negative binomial model using age, sex, smoking, and FEV 1 % predicted as clinical covariates. BALF iron and ferritin were higher in participants with copD and in smokers without copD when compared to non-smoker control participants but did not correlate with systemic iron markers. BALF ferritin and iron were elevated in participants who had COPD exacerbations, with a 2-fold increase in BALF ferritin and iron conveying a 24% and 2-fold increase in exacerbation risk, respectively. Similar associations were not observed with plasma ferritin. increased airway iron levels may be representative of a distinct pathobiological phenomenon that results in more frequent COPD exacerbation events, contributing to disease progression in these individuals.

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

Cited by 22 publications

References 41 publications

Bronchial Rheoplasty for Treatment of Chronic Bronchitis. Twelve-Month Results from a Multicenter Clinical Trial

Bronchial Rheoplasty for Treatment of Chronic Bronchitis. Twelve-Month Results from a Multicenter Clinical Trial

Current smoking with or without chronic bronchitis is independently associated with goblet cell hyperplasia in healthy smokers and COPD subjects

Increased airway iron parameters and risk for exacerbation in COPD: an analysis from SPIROMICS

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