Three-center feasibility of lung clearance index in infants and preschool children with cystic fibrosis and other lung diseases

Mirjam Stahl¹, Simon Y Graeber², Cornelia Joachim², Sandra Barth³, Isabell Ricklefs⁴, Gesa Diekmann⁴, Matthias V Kopp⁴, Lutz Naehrlich³, Marcus A Mall⁵

Affiliations

¹ Division of Pediatric Pulmonology and Allergy and Cystic Fibrosis Center, Department of Pediatrics, University of Heidelberg, Im Neuenheimer Feld 430, 69120 Heidelberg, Germany; Department of Translational Pulmonology, Translational Lung Research Center Heidelberg (TLRC), German Centre for Lung Research (DZL), University of Heidelberg, Im Neuenheimer Feld 156, 69120 Heidelberg, Germany. Electronic address: Mirjam.Stahl@med.uni-heidelberg.de.
² Division of Pediatric Pulmonology and Allergy and Cystic Fibrosis Center, Department of Pediatrics, University of Heidelberg, Im Neuenheimer Feld 430, 69120 Heidelberg, Germany; Department of Translational Pulmonology, Translational Lung Research Center Heidelberg (TLRC), German Centre for Lung Research (DZL), University of Heidelberg, Im Neuenheimer Feld 156, 69120 Heidelberg, Germany.
³ Department of Pediatrics, Justus-Liebig-University Giessen, Feulgenstrasse 10-12, 35392 Giessen, Germany; Universities Giessen and Marburg Lung Centre (UGMLC), German Centre for Lung Research (DZL), Aulweg 130, 35392 Giessen, Germany.
⁴ Department of Pediatric Allergology and Pneumology, Medical University of Lübeck, Ratzeburger Allee 160, 23538 Lübeck, Germany; Airway Research Centre North (ARCN), German Centre for Lung Research (DZL), Ratzeburger Allee 160, 23538 Lübeck, Germany.
⁵ Division of Pediatric Pulmonology and Allergy and Cystic Fibrosis Center, Department of Pediatrics, University of Heidelberg, Im Neuenheimer Feld 430, 69120 Heidelberg, Germany; Department of Translational Pulmonology, Translational Lung Research Center Heidelberg (TLRC), German Centre for Lung Research (DZL), University of Heidelberg, Im Neuenheimer Feld 156, 69120 Heidelberg, Germany; Department of Pediatric Pulmonology and Immunology, Charité - Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: Marcus.Mall@med.uni-heidelberg.de.

PMID: 28811149
DOI: 10.1016/j.jcf.2017.08.001

Free article

Multicenter Study

Three-center feasibility of lung clearance index in infants and preschool children with cystic fibrosis and other lung diseases

Mirjam Stahl et al. J Cyst Fibros. 2018 Mar.

Free article

. 2018 Mar;17(2):249-255.

doi: 10.1016/j.jcf.2017.08.001. Epub 2017 Aug 12.

Authors

Mirjam Stahl¹, Simon Y Graeber², Cornelia Joachim², Sandra Barth³, Isabell Ricklefs⁴, Gesa Diekmann⁴, Matthias V Kopp⁴, Lutz Naehrlich³, Marcus A Mall⁵

Affiliations

¹ Division of Pediatric Pulmonology and Allergy and Cystic Fibrosis Center, Department of Pediatrics, University of Heidelberg, Im Neuenheimer Feld 430, 69120 Heidelberg, Germany; Department of Translational Pulmonology, Translational Lung Research Center Heidelberg (TLRC), German Centre for Lung Research (DZL), University of Heidelberg, Im Neuenheimer Feld 156, 69120 Heidelberg, Germany. Electronic address: Mirjam.Stahl@med.uni-heidelberg.de.
² Division of Pediatric Pulmonology and Allergy and Cystic Fibrosis Center, Department of Pediatrics, University of Heidelberg, Im Neuenheimer Feld 430, 69120 Heidelberg, Germany; Department of Translational Pulmonology, Translational Lung Research Center Heidelberg (TLRC), German Centre for Lung Research (DZL), University of Heidelberg, Im Neuenheimer Feld 156, 69120 Heidelberg, Germany.
³ Department of Pediatrics, Justus-Liebig-University Giessen, Feulgenstrasse 10-12, 35392 Giessen, Germany; Universities Giessen and Marburg Lung Centre (UGMLC), German Centre for Lung Research (DZL), Aulweg 130, 35392 Giessen, Germany.
⁴ Department of Pediatric Allergology and Pneumology, Medical University of Lübeck, Ratzeburger Allee 160, 23538 Lübeck, Germany; Airway Research Centre North (ARCN), German Centre for Lung Research (DZL), Ratzeburger Allee 160, 23538 Lübeck, Germany.
⁵ Division of Pediatric Pulmonology and Allergy and Cystic Fibrosis Center, Department of Pediatrics, University of Heidelberg, Im Neuenheimer Feld 430, 69120 Heidelberg, Germany; Department of Translational Pulmonology, Translational Lung Research Center Heidelberg (TLRC), German Centre for Lung Research (DZL), University of Heidelberg, Im Neuenheimer Feld 156, 69120 Heidelberg, Germany; Department of Pediatric Pulmonology and Immunology, Charité - Universitätsmedizin Berlin, Augustenburger Platz 1, 13353 Berlin, Germany. Electronic address: Marcus.Mall@med.uni-heidelberg.de.

PMID: 28811149
DOI: 10.1016/j.jcf.2017.08.001

Abstract

Background: Lung clearance index (LCI) detects early ventilation inhomogeneity and has been suggested as sensitive endpoint in multicenter intervention trials in infants and preschoolers with cystic fibrosis (CF). However, the feasibility of multicenter LCI in this age group has not been determined. We, therefore, investigated the feasibility of LCI in infants and preschoolers with and without CF in a three-center setting.

Methods: Following central training, standardized SF₆-MBW measurements were performed in 73 sedated children (10 controls, 49 with CF and 14 with other lung diseases), mean age 2.3±1.2years across three centers, and data were analyzed centrally.

Results: Overall success rate of LCI measurements was 91.8% ranging from 78.9% to 100% across study sites. LCI was increased in patients with CF (P<0.05) and with other lung diseases (P<0.05) compared to controls.

Conclusion: Our results support feasibility of LCI as multicenter endpoint in clinical trials in infants and preschoolers with CF.

Keywords: Clinical trial endpoint; Early CF lung disease; Infant lung function test; Lung clearance index; Multiple breath washout.

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Three-center feasibility of lung clearance index in infants and preschool children with cystic fibrosis and other lung diseases

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Three-center feasibility of lung clearance index in infants and preschool children with cystic fibrosis and other lung diseases

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