Response to albuterol delivered through an anti-static valved holding chamber during nocturnal bronchospasm

Institution : University of Florida

Publication Source: From the Pediatric Pulmonary Division and Division of Biostatistics, Department of Epidemiology and Health Policy Research, College of Medicine, and the Department of Pharmacotherapy and Translational Research, College of Pharmacy.

Background:
Electrostatic charge (ESC) on valved holding chambers (VHCs) decreases drug delivery while reducing ESC increases the amount of drug reaching the airways. However, there are no data on the clinical relevance of this finding in patients with acute bronchospasm.
Objective:
To determine whether reducing ESC increases bronchodilator response to albuterol during nocturnal bronchospasm.
Methods:
This was a randomized, double-blind, double-dummy, crossover study.  Subjects 18-65 years with nocturnal bronchospasm and FEV1 60-80% predicted during the day were included if they had a bronchodilator response of ≥12% up to at least 80% predicted after 2-4 puffs of albuterol HFA MDI delivered by anti-static VHC. Subjects slept in the Clinical Research Center (C.R.C.) on two different nights. FEV1 and heart rate were measured upon awakening with acute bronchospasm and 15 minutes after each dose of 1, 1, and 2 puffs of albuterol (1, 2 and 4 cumulative puffs) administered through an anti-static VHC (AeroChamber Plus Z-Stat®) and static VHC (AeroChamber Plus®) with an ESC.
Results:
Eighty-eight subjects signed informed consent,11 were randomized and 7 completed the study. Most screen failures were a result of FEV1 being too high upon awakening.
Upon awakening or at 4:00 am the FEV1 was precipitously lower than the evening values; 44±9% predicted before anti-static chamber and 48±7% predicted before static chamber. The mean (±SD) % increase in FEV1 after 1, 2 and 4 cumulative puffs using anti-static vs static chambers were 52±26 vs 29±17, 73±28 vs 48±26 and 90±34 vs 64±35 respectively. The bronchodilator response was statistically significant at each dose but the overall result was not because of the small sample size.
There were no adverse effects.
Conclusion: Delivery of albuterol through an anti-static chamber significantly improves bronchodilator response during nocturnal bronchospasm.

Supported by Children’s Miracle Network research grant (2008-2009).
(ClinicalTrials.gov #  NCT01111110 )