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Lung function distinguishes preschool children with CF from healthy controls in a multi-center setting

Gwendolyn S Kerby1, Margaret Rosenfeld, Clement L Ren

  • 1Children's Hospital Colorado, University of Colorado, 13123 E 16th Ave, B395, Aurora, Colorado 80045, USA. gwendolyn.kerby@childrenscolorado.org

Pediatric Pulmonology
|November 15, 2011
PubMed

Insights

Spirometry is the most sensitive lung function test for cystic fibrosis (CF) preschoolers, though challenges remain. This study assessed lung function measures in CF children to guide future clinical trials.

Area of Science:

  • Pediatric Pulmonology
  • Clinical Trial Methodology
  • Respiratory Physiology

Background:

  • Clinical trials in cystic fibrosis (CF) preschoolers are hindered by the lack of sensitive, multi-center lung function measures.
  • Developing reliable methods is crucial for evaluating interventions in this population.

Purpose of the Study:

  • Assess feasibility and reproducibility of spirometry, forced oscillometry (FO), and inductance plethysmography (IP) in preschool CF patients.
  • Compare the ability of these techniques to differentiate lung function between CF preschoolers and controls.
  • Evaluate longitudinal lung function changes and estimate sample sizes for future trials.

Main Methods:

  • A longitudinal, multi-center study involving 93 CF preschoolers and 87 controls.
  • Standardized equipment, rigorous site training, and centralized data review were employed.
  • CF subjects had up to four study visits (6 months apart) plus a reproducibility visit; controls had one visit.

Main Results:

  • Inductance plethysmography (IP) showed the highest acceptability (77%), while spirometry had the lowest (55%).
  • Spirometry indices (FEV(1), FEV(0.5), FEF(25-75)) were lower in CF subjects and declined with age.
  • Forced oscillometry (FO) indices did not distinguish CF from controls, but spirometry detected the smallest treatment effect.

Conclusions:

  • Spirometry is more sensitive than IP or FO for detecting lung disease in CF preschoolers, with indices declining by age.
  • Future CF trials should incorporate spirometry training and require acceptable pre-enrollment data.
  • Near-normal spirometry in preschoolers may complicate treatment effect detection.
Abstract

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