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.
Highlights
Inhalers are essential for noninvasive delivery of drugs directly to the lungs, and a range of devices are available
Are critical to successful inhalation therapy.[3,7] Lack of coordination of actuation and inhalation is a common problem in children using pressurized metered-dose inhalers, with inhalation being either too early or too late.[3] many studies show that improper inhaler technique is common in children, resulting in reduced or no benefit.[6,8,9] In addition, young children may be unable to generate sufficient airflow required by some devices.[3,5]
Successful inhalation therapy in young children depends on cooperation, the technical properties of the inhalation device, and the ability of the child to perform a correct inhalation maneuver with the device.[3,7,11] Several features of the Respimat Soft MistÔ Inhaler (SMI) recommend its use in the pediatric population
Summary
Inhalers are essential for noninvasive delivery of drugs directly to the lungs, and a range of devices are available. The ideal inhaler for young children would be an active device that is easy to handle, with no requirement for the coordination of actuation and inhalation, an emitted dose delivered effectively to the lungs independent of inspiratory flow, and a formulation suitable for use with a valved holding chamber with facemask (VHC).(3) The Respimatâ Soft MistÔ Inhaler (SMI) is a novel, handheld, propellant-free, multidose inhalation device that generates a slow-moving, long-lasting aerosol plume containing a large fine-particle fraction (FPF < 5 lm) that enables efficient drug delivery to the lungs.[10,11,12] The emitted dose is independent of the inspiratory flow and the Respimat SMI is easy to use. 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). Conclusions: The Respimat SMI is suitable for children aged < 5 years; children aged < 5 years are advised to add a VHC to complement its use
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callMore From: Journal of Aerosol Medicine and Pulmonary Drug Delivery
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
