title: Infant lung function tests as endpoints in the ISIS multicenter clinical trial in cystic fibrosis.
abstract: The Infant Study of Inhaled Saline (ISIS) in CF was the first multicenter clinical trial to utilize infant pulmonary function tests (iPFTs) as an endpoint.
  
  
  
  Secondary analysis of ISIS data was conducted in order to assess feasibility of iPFT measures and their associations with respiratory symptoms. Standard deviations were calculated to aid in power calculations for future clinical trials.
  
  
  
  Seventy-three participants enrolled, 70 returned for the final visit; 62 (89%) and 45 (64%) had acceptable paired functional residual capacity (FRC) and raised volume measurements, respectively. Mean baseline FEV0.5, FEF75 and FRC z-scores were 0.3 (SD: 1.2), -0.2 (SD: 2.0), and 1.8 (SD: 2.0).
  
  
  
  iPFTs are not appropriate primary endpoints for multicenter clinical trials due to challenges of obtaining acceptable data and near-normal average raised volume measurements. Raised volume measures have potential to serve as secondary endpoints in future clinical CF trials.
authors.affiliation: Section of Pediatric Pulmonology, Allergy and Sleep Medicine, Department of Pediatrics, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN, USA.
authors.forename: Stephanie D
authors.initials: SD
authors.lastname: Davis
authors.affiliation: Division of Respiratory Medicine, Department of Pediatrics, the Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
authors.forename: Felix
authors.initials: F
authors.lastname: Ratjen
authors.affiliation: Department of Biostatistics, University of Washington, Seattle, WA, USA.
authors.forename: Lyndia C
authors.initials: LC
authors.lastname: Brumback
authors.affiliation: Division of Pediatric Pulmonology, Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Robin C
authors.initials: RC
authors.lastname: Johnson
authors.affiliation: Pediatric Pulmonary Division, Department of Pediatrics, CS Mott Children's Hospital, University of Michigan School of Medicine, Ann Arbor, MI, USA.
authors.forename: Amy G
authors.initials: AG
authors.lastname: Filbrun
authors.affiliation: Department of Pediatrics, The Breathing Institute, University of Colorado and Children's Hospital, Aurora, CO, USA.
authors.forename: Gwendolyn S
authors.initials: GS
authors.lastname: Kerby
authors.affiliation: Division of Pulmonary Medicine, Department of Pediatrics, The Children's Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
authors.forename: Howard B
authors.initials: HB
authors.lastname: Panitch
authors.affiliation: Division of Pulmonary and Critical Care, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.
authors.forename: Scott H
authors.initials: SH
authors.lastname: Donaldson
authors.affiliation: Division of Pulmonary Medicine, Seattle Children's Hospital and Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.
authors.forename: Margaret
authors.initials: M
authors.lastname: Rosenfeld
mesh_terms: D003550:Cystic Fibrosis / Q000175:diagnosis / Q000503:physiopathology; D061827:Dimensional Measurement Accuracy; D005260:Female; D005541:Forced Expiratory Volume; D006801:Humans; D007223:Infant; D008168:Lung / Q000503:physiopathology*; D008297:Male; D012129:Respiratory Function Tests / Q000379:methods*; D012965:Sodium Chloride / Q000494:pharmacology
chemical_list: D012965:Sodium Chloride
keywords: FEV; Forced expiratory flow rates; Pulmonary function tests