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J Aerosol Med Pulm Drug Deliv. 2015 Oct;28(5):372-81. doi: 10.1089/jamp.2014.1159. Epub 2015 Apr 6.

A Handling Study to Assess Use of the Respimat(®) Soft Mist™ Inhaler in Children Under 5 Years Old.

Author information

1
1 Children's Hospital , Evangelisches Krankenhaus Hamm, Hamm, Germany .
2
2 Boehringer Ingelheim , Ingelheim, Germany .
3
3 Children's Hospital, Allergology, Pneumology and Cystic Fibrosis, Goethe-University , Frankfurt am Main, Germany .

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.

KEYWORDS:

Respimat® Soft Mist™ Inhaler; device handling; inhalation flow profiles; preschool children; respiratory disease

PMID:
25844687
PMCID:
PMC4601632
DOI:
10.1089/jamp.2014.1159
[Indexed for MEDLINE]
Free PMC Article

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