title: A Handling Study to Assess Use of the Respimat(®) Soft Mist™ Inhaler in Children Under 5 Years Old.
abstract: BACKGROUND
  Respimat(®) Soft Mist(™) Inhaler (SMI) is a hand-held device that generates an aerosol with a high, fine-particle fraction, enabling efficient lung deposition. The study objective was to assess inhalation success among children using Respimat SMI, and the requirement for assistance by the parent/caregiver and/or a valved holding chamber (VHC).
  
  
  METHODS
  This open-label study enrolled patients aged <5 years with respiratory disease and history of coughing and/or recurrent wheezing. Patients inhaled from the Respimat SMI (air only; no aerosol) using a stepwise configuration: "1" (dose released by child); "2" (dose released by parent/caregiver), and "3" (Respimat SMI with VHC, facemask, and parent/caregiver help). Co-primary endpoints included the ability to perform successful inhalation as assessed by the investigators using a standardized handling questionnaire and evaluation of the reasons for success. Inhalation profile in the successful handling configuration was verified with a pneumotachograph. Patient satisfaction and preferences were investigated in a questionnaire.
  
  
  RESULTS
  Of the children aged 4 to <5 years (n=27) and 3 to <4 years (n=30), 55.6% and 30.0%, respectively, achieved success without a VHC or help; with assistance, another 29.6% and 10.0%, respectively, achieved success, and the remaining children were successful with VHC. All children aged 2 to <3 years (n=20) achieved success with the Respimat SMI and VHC. Of those aged <2 years (n=22), 95.5% had successful handling of the Respimat SMI with VHC and parent/caregiver help. Inhalation flow profiles generally confirmed the outcome of the handling assessment by the investigators. Most parent/caregiver and/or child respondents were satisfied with operation, instructions for use, handling, and ease of holding the Respimat SMI with or without a VHC.
  
  
  CONCLUSIONS
  The Respimat SMI is suitable for children aged <5 years; however, children aged <5 years are advised to add a VHC to complement its use.
authors.affiliation: 1 Children's Hospital , Evangelisches Krankenhaus Hamm, Hamm, Germany .
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Kamin
authors.affiliation: 2 Boehringer Ingelheim , Ingelheim, Germany .
authors.forename: Marion
authors.initials: M
authors.lastname: Frank
authors.affiliation: 2 Boehringer Ingelheim , Ingelheim, Germany .
authors.forename: Sabine
authors.initials: S
authors.lastname: Kattenbeck
authors.affiliation: 2 Boehringer Ingelheim , Ingelheim, Germany .
authors.forename: Petra
authors.initials: P
authors.lastname: Moroni-Zentgraf
authors.affiliation: 2 Boehringer Ingelheim , Ingelheim, Germany .
authors.forename: Herbert
authors.initials: H
authors.lastname: Wachtel
authors.affiliation: 3 Children's Hospital, Allergology, Pneumology and Cystic Fibrosis, Goethe-University , Frankfurt am Main, Germany .
authors.forename: Stefan
authors.initials: S
authors.lastname: Zielen
mesh_terms: D000367:Age Factors; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D009330:Nebulizers and Vaporizers
keywords: Respimat® Soft Mist™ Inhaler; device handling; inhalation flow profiles; preschool children; respiratory disease
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