title: Asthma outcomes: pulmonary physiology.
abstract: BACKGROUND
  Outcomes of pulmonary physiology have a central place in asthma clinical research.
  
  
  OBJECTIVE
  At the request of National Institutes of Health (NIH) institutes and other federal agencies, an expert group was convened to provide recommendations on the use of pulmonary function measures as asthma outcomes that should be assessed in a standardized fashion in future asthma clinical trials and studies to allow for cross-study comparisons.
  
  
  METHODS
  Our subcommittee conducted a comprehensive search of PubMed to identify studies that focused on the validation of various airway response tests used in asthma clinical research. The subcommittee classified the instruments as core (to be required in future studies), supplemental (to be used according to study aims and in a standardized fashion), or emerging (requiring validation and standardization). This work was discussed at an NIH-organized workshop in March 2010 and finalized in September 2011.
  
  
  RESULTS
  A list of pulmonary physiology outcomes that applies to both adults and children older than 6 years was created. These outcomes were then categorized into core, supplemental, and emerging. Spirometric outcomes (FEV(1), forced vital capacity, and FEV(1)/forced vital capacity ratio) are proposed as core outcomes for study population characterization, for observational studies, and for prospective clinical trials. Bronchodilator reversibility and prebronchodilator and postbronchodilator FEV(1) also are core outcomes for study population characterization and observational studies.
  
  
  CONCLUSIONS
  The subcommittee considers pulmonary physiology outcomes of central importance in asthma and proposes spirometric outcomes as core outcomes for all future NIH-initiated asthma clinical research.
authors.affiliation: Indiana University, Indianapolis, Indiana, USA.
authors.forename: Robert S
authors.initials: RS
authors.lastname: Tepper
authors.forename: Robert S
authors.initials: RS
authors.lastname: Wise
authors.forename: Ronina
authors.initials: R
authors.lastname: Covar
authors.forename: Charles G
authors.initials: CG
authors.lastname: Irvin
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Kercsmar
authors.forename: Monica
authors.initials: M
authors.lastname: Kraft
authors.forename: Mark C
authors.initials: MC
authors.lastname: Liu
authors.forename: George T
authors.initials: GT
authors.lastname: O'Connor
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Peters
authors.forename: Ronald
authors.initials: R
authors.lastname: Sorkness
authors.forename: Alkis
authors.initials: A
authors.lastname: Togias
mesh_terms: D000328:Adult; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy / Q000503:physiopathology*; D035843:Biomedical Research / Q000592:standards; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D002648:Child; D006801:Humans; D008168:Lung / Q000503:physiopathology*; D012129:Respiratory Function Tests / Q000592:standards; D013147:Spirometry; D016896:Treatment Outcome
chemical_list: D001993:Bronchodilator Agents