Zichen Ji, Ángela Gómez-Sacristán, Walther Iván Girón-Matute*, Raquel Terán-Marcos, Luis Puente-Maestu
Ji et al. J Clin Transl Res 2023; 9(5):23-00081
Published online: September 27, 2023
Abstract
Background: Aerochambers are used for the administration of inhaled drugs. Dosivent® is a
previously unstudied chamber. This study aimed to validate the Dosivent® chamber against the widely
used Aerochamber Plus® Flow-Vu®.
Methods: We conducted a non-randomized, open-label, cross-over-controlled, and clinical trial
(NCT05821868) in 50 patients with a known positive bronchodilator test. Bronchodilator washout
was performed according to standard recommendations. Fifteen minutes after the administration
of 400 μg of salbutamol with either chamber, the changes in forced expiratory volume in the first
second (FEV1) and forced vital capacity (FVC) were measured. The agreement was measured by the
intraclass correlation coefficient and Bland–Altman graphical analysis. Participants’ satisfaction with
the chamber was assessed with the FSI-10 questionnaire.
Results: The mean participant age was 58.0 (SD = 18.5) years, half were women, and only 31 (62%)
participants had an FEV1/FVC of <0.7. The median increases in FEV1 obtained with the Aerochamber
Plus® Flow-Vu® and Dosivent® were 0.28 L (interquartile range [IQR]: 0.21 – 0.38) and 0.29 L (IQR:
0.20 – 0.43), respectively, and the median increases in FVC were 0.29 L (IQR: 0.19 – 0.37) and 0.28 L
(IQR: 0.19 – 0.45). The intraclass correlation coefficient for increases in FEV1 was 0.865, and it
was 0.820 for increases in FVC. The median FSI-10 questionnaire score was 42 (IQR: 37 – 47) with
Aerochamber Plus® Flow-Vu® and 44 (39 – 48) with Dosivent® (P < 0.001).
Conclusions: Our study revealed a strong agreement between salbutamol responses when utilizing
both the Dosivent® and Aerochamber Plus® Flow-Vu® chambers. This suggests that these devices are
interchangeable and can be effectively employed in routine clinical practice.
Relevance for Patients: For patients using inhaled medications, this study provides reassurance
regarding the equivalence of the Dosivent® chamber with the widely used Aerochamber Plus® Flow-
Vu®. This provides patients with more options for device selection, potentially improving convenience
and satisfaction with their inhalation therapy. Patients and healthcare providers can consider the
Dosivent® chamber as a viable alternative, which may positively impact treatment adherence and
overall respiratory health management.
DOI: http://dx.doi.org/10.18053/jctres.09.202305.23-00081
Author affiliation
1. Department of Respiratory, Gregorio Marañón General University Hospital, 28007 Madrid, Spain,
2. Gregorio Marañón Hospital Biomedical
Investigation Institute, 28007 Madrid, Spain,
3. Department of Medicine, Faculty of Medicine, Complutense University of Madrid, 28040 Madrid, Spain.
*Corresponding author
Walther Iván Girón-Matute
Department of Respiratory, Gregorio Marañón
General University Hospital,
28007 Madrid, Spain.
Tel.: +34 91 586 83 36
E-mail: walter_giron2@hotmail.com
Handling editor:
Michal Heger
Department of Pharmaceutics, Utrecht University, the Netherlands
Department of Chemistry, Utrecht University, Utrecht, the Netherlands
Department of Pathology, Erasmus Medical Center, the Netherlands
Department of Pharmaceutics, Jiaxing University Medical College, Zhejiang, China
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