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.

In vitro and clinical characterization of the valved holding chamber AeroChamber Plus ® Flow-Vu ® for administrating tiotropium Respimat ® in 1–5-year-old children with persistent asthmatic symptoms

“…The Respimat ® , which is currently the only commercially available soft mist inhaler, contains a mechanical spring that atomizes the drug solution, creating a fine, slow-moving mist with a relatively higher deposition in the lung, and less drug deposited in the mouth and throat [29]. A recent handling study of the Respimat ® in children under 5 years old found that all children using the Aero-Chamber Plus ® Flow-Vu ® VHC and face mask, either by themselves or with adult assistance, achieved successful handling, and thus recommended that a VHC should be used to administer tiotropium via the Respimat ® in children younger than 5 years old [19]. In addition to ensuring correct handling of the device, there is also a need for safety and optimal clinical control of aerosol delivery in children, and for a realistic prediction of the dose delivered to the lung.…”

“…A previous in vitro study using throat models of children approximately 5 years old found that the use of the AeroChamber Plus ® Flow-Vu ® VHC for administering tiotropium Respimat ® provided optimal dose-to-lung (DTL) in comparison with other VHCs, whilst minimizing retention at throat level [17]. Patients over the age of 5 years who are able to exhibit proper inhaler technique have been reported as having effective clinical outcomes following use of the Respimat ® without a VHC [18]; moreover, children younger than 5 years can handle the Respimat ® well when using a suitable VHC to complement its use [19].…”

Oronasal and Tracheostomy Delivery of Soft Mist and Pressurized Metered-Dose Inhalers With Valved Holding Chamber

“…6,7 However, handling studies of the Respimat device recommend the addition of a VHC in children Յ5 y old. 8 The Respimat with a VHC effectively delivered aerosol to a group of sleeping infants. 9 Due to the paucity of clinical studies, most of our insight on optimization of aerosol delivery with pMDIs and VHCs through tracheostomy derives from in vitro studies.…”

The Respimat® Development Story: Patient-Centered Innovation

“…A study assessing handling and inhalation flow profiles found that all children aged \5 years could achieve inhalation success with basic training and assistance from a parent/caregiver [43]. The assessment of the theoretical dose delivered to the lung from inhalation flow profiles has been shown to confirm and complement pharmacokinetic analyses conducted in clinical trials of children of the same age group with cystic fibrosis [44].…”

“…It provides efficient drug delivery in pediatric patients [37,43,55], including children \5 years when using a spacer [27,43]. In one study, anecdotal evidence suggested that children aged 6-15 years found it easy to learn how to use Respimat Ò and preferred this inhaler to using an MDI [37].…”