Abstract

Objectives: For effective treatment of CF with inhaled drugs, efficient, easy to use devices are needed. This study was designed to assess time and practicability of Alpha-1-Antitrypsin (A1-PI(H)), (77mg/1.1ml) lung deposition in CF patients. Methods: Using the Respironics I-Neb AAD System. 15 mild to severe CF patients (FEV1: 34–101%) were included to inhale study drug in two inhalation modes: Target Inhalation Mode (TIM) and Tidal Breathing Mode (TBM). Conclusion: Total inhalation time was lower in TIM (3±0.5 min) than in TBM (4.5±2.1 min). Inhalation time and volume inhaled per breath were lower in TBM than in TIM. Subjects inhaled more deeply and slowly in TIM. Consequently, treatment time was longer and the number of breaths needed to deliver a similar dose was higher in TBM than in TIM. In both inhalation modes a high percentage of CF subjects rated their mouthpiece exhalation as “easy” and “very easy” (TIM: 80%, TBM: 100%). In total, 87% of the CF subjects classified their mouthpiece inhalation through in TBM as “easy” and “very easy” (TIM: 40%). For both inhalation modes a high percentage of CF subjects classified the use of the I-neb as “easy” and “very easy” (TIM: 71.5%, TBM: 86.7%). All CF patients were able to inhale the full dose in <6min in TIM and <10min in TBM. TIM is consistently more efficient and less time consuming than TBM, as reflected in total treatment and inhalation time, and number of breaths. All CF patients could handle the device properly and most of them rated its use as easy or very easy.

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