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Inspiromatic‐safety and efficacy study of a new generation dry powder inhaler in asthmatic children
Author(s) -
Steuer Guy,
Prais Dario,
Mussaffi Huda,
MeiZahav Meir,
BarOn Ophir,
Levine Hagit,
Gendler Yulia,
Blau Hannah,
Stafler Patrick
Publication year - 2018
Publication title -
pediatric pulmonology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.866
H-Index - 106
eISSN - 1099-0496
pISSN - 8755-6863
DOI - 10.1002/ppul.24077
Subject(s) - medicine , dry powder inhaler , inhaler , placebo , formoterol , asthma , inhalation , anesthesia , spirometry , heart rate , blood pressure , alternative medicine , pathology , budesonide
Abstract Background Dry powder inhalers (DPI) are effective but forceful inhalation required to fluidize the powder may be difficult for children and patients with airway disease. Inspiromatic is a new generation active DPI that actively suspends drugs in synchrony with inhalation. We evaluated safety and efficacy of Formoterol delivery via Inspiromatic, compared to Aerolizer, a conventional DPI, in pediatric asthmatic subjects. Methods A phase I/II, randomized, single‐center, double‐blind, double‐dummy, placebo‐controlled, cross‐over study. Subjects aged 8‐18 years with FEV 1 40‐80% predicted were included. Patients were randomized to inhale Formoterol via the Inspiromatic, immediately followed by the placebo via the Aerolizer or vice versa, in a double‐blind fashion. Spirometry, blood pressure, and heart rate were measured at baseline and 15, 30, and 60 min after drug administration. Capsule emptying, comfort of use, confidence in efficacy, and patient satisfaction were assessed. At a subsequent visit, three months later, patients inhaled the active drug via the other DPI. Results Twenty‐nine patients, aged 12.6 (±2.3) years, mean (SD), completed the study. Baseline FEV 1 was 69.1 (±6.7) % at visit one and 65.3 (±9) % at visit two. Maximal FEV 1 increase was 16.6 (±7.1) % with Inspiromatic and 15.5 (±7.5) % with Aerolizer ( P = 0.47). No differences in heart rate or blood pressure were observed; 24/28 capsules were emptied using the Inspiromatic and 19/28 with the Aerolizer ( P = 0.5); 21/28 preferred the Inspiromatic and 7/28 the Aerolizer ( P < 0.001). There were no adverse events. Conclusions Formoterol inhalation via the Inspiromatic is safe and as efficacious as with the Aerolizer. The device is well accepted by asthmatic subjects.