A handling study to assess use of the Respimat(®) Soft Mist™ inhaler in children under 5 years old
- 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.
Author: | Wolfgang Kamin, Marion Frank, Sabine Kattenbeck, Petra Moroni-Zentgraf, Herbert Wachtel, Stefan ZielenORCiDGND |
---|---|
URN: | urn:nbn:de:hebis:30:3-425873 |
DOI: | https://doi.org/10.1089/jamp.2014.1159 |
ISSN: | 1941-2703 |
ISSN: | 1941-2711 |
Pubmed Id: | https://pubmed.ncbi.nlm.nih.gov/25844687 |
Parent Title (English): | Journal of aerosol medicine and pulmonary drug delivery |
Publisher: | Liebert |
Place of publication: | New York, NY |
Document Type: | Article |
Language: | English |
Year of Completion: | 2017 |
Year of first Publication: | 2015 |
Publishing Institution: | Universitätsbibliothek Johann Christian Senckenberg |
Release Date: | 2017/01/19 |
Tag: | Respimat® Soft Mist™ Inhaler; device handling; inhalation flow profiles; preschool children; respiratory disease |
Volume: | 28 |
Issue: | 5 |
Page Number: | 10 |
First Page: | 372 |
Last Page: | 381 |
Note: | (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. |
HeBIS-PPN: | 423546910 |
Institutes: | Medizin / Medizin |
Dewey Decimal Classification: | 6 Technik, Medizin, angewandte Wissenschaften / 61 Medizin und Gesundheit / 610 Medizin und Gesundheit |
Sammlungen: | Universitätspublikationen |
Licence (German): | Creative Commons - Namensnennung 4.0 |