TY  - JOUR
A1  - Kamin, Wolfgang
A1  - Frank, Marion
A1  - Kattenbeck, Sabine
A1  - Moroni-Zentgraf, Petra
A1  - Wachtel, Herbert
A1  - Zielen, Stefan
T1  - A handling study to assess use of the Respimat(®) Soft Mist™ inhaler in children under 5 years old
T2  - Journal of aerosol medicine and pulmonary drug delivery
N2  - 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.
KW  - device handling
KW  - inhalation flow profiles
KW  - preschool children
KW  - Respimat® Soft Mist™ Inhaler
KW  - respiratory disease
Y1  - 2017
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/42587
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-425873
SN  - 1941-2703
SN  - 1941-2711
N1  - (c) The Author(s) 2015; Published by Mary Ann Liebert, Inc. This Open Access article is distributed under the terms of the Creative Commons License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any
medium, provided the original work is properly credited.
VL  - 28
IS  - 5
SP  - 372
EP  - 381
PB  - Liebert
CY  - New York, NY
ER  -