BACKGROUND: Decreasing electrostatic charge on valved holding chambers increases the amount of drug delivered. However, there are no data demonstrating that this increases bronchodilatation. OBJECTIVE: To investigate the influence of reducing electrostatic charge on the bronchodilator response to albuterol inhaler during nocturnal bronchospasm. METHODS: This randomized double-blind, double-dummy crossover study included subjects, 18-40 years old, with nocturnal bronchospasm (20% overnight decrease in peak flow on 3 of 7 nights during run-in), FEV(1) 60-80% predicted during the day, and ≥ 12% increase after albuterol. Subjects slept in the clinical research center up to 3 nights for each treatment. FEV(1) and heart rate were measured upon awakening spontaneously or at 4:00 am, and 15 min after each dose of 1, 2, and 4 cumulative puffs of albuterol via metered-dose inhaler. The drug was administered through an anti-static valved holding chamber (AeroChamber Plus Z-Stat) or a conventional valved holding chamber containing a static charge (AeroChamber Plus). RESULTS: Of 88 consented subjects, 11 were randomized and 7 completed the study. Most exclusions were due to lack of objective evidence of nocturnal bronchospasm. Upon awakening, FEV(1) was 44 ± 9% of predicted before the anti-static chamber and 48 ± 7% of predicted before the static chamber. The mean ± SD percent increase in FEV(1) after 1, 2, and 4 cumulative puffs using the anti-static versus the static chamber, respectively, were 52 ± 26% versus 30 ± 19%, 73 ± 28% versus 48 ± 26%, and 90 ± 34% versus 64 ± 35%. The point estimates for the differences (and 95% CIs) between the devices (anti-static vs static) were 21% (4-38%) (P = .03), 23% (6-41%) (P = .02), and 25% (7-42%) (P = .01) for 1, 2, and 4 cumulative puffs, respectively. There was no significant difference in heart rate between treatments. CONCLUSIONS: Delivery of albuterol through an anti-static chamber provides a clinically relevant improvement in bronchodilator response during acute, reversible bronchospasm such as nocturnal bronchospasm.
RCT Entities:
BACKGROUND: Decreasing electrostatic charge on valved holding chambers increases the amount of drug delivered. However, there are no data demonstrating that this increases bronchodilatation. OBJECTIVE: To investigate the influence of reducing electrostatic charge on the bronchodilator response to albuterol inhaler during nocturnal bronchospasm. METHODS: This randomized double-blind, double-dummy crossover study included subjects, 18-40 years old, with nocturnal bronchospasm (20% overnight decrease in peak flow on 3 of 7 nights during run-in), FEV(1) 60-80% predicted during the day, and ≥ 12% increase after albuterol. Subjects slept in the clinical research center up to 3 nights for each treatment. FEV(1) and heart rate were measured upon awakening spontaneously or at 4:00 am, and 15 min after each dose of 1, 2, and 4 cumulative puffs of albuterol via metered-dose inhaler. The drug was administered through an anti-static valved holding chamber (AeroChamber Plus Z-Stat) or a conventional valved holding chamber containing a static charge (AeroChamber Plus). RESULTS: Of 88 consented subjects, 11 were randomized and 7 completed the study. Most exclusions were due to lack of objective evidence of nocturnal bronchospasm. Upon awakening, FEV(1) was 44 ± 9% of predicted before the anti-static chamber and 48 ± 7% of predicted before the static chamber. The mean ± SD percent increase in FEV(1) after 1, 2, and 4 cumulative puffs using the anti-static versus the static chamber, respectively, were 52 ± 26% versus 30 ± 19%, 73 ± 28% versus 48 ± 26%, and 90 ± 34% versus 64 ± 35%. The point estimates for the differences (and 95% CIs) between the devices (anti-static vs static) were 21% (4-38%) (P = .03), 23% (6-41%) (P = .02), and 25% (7-42%) (P = .01) for 1, 2, and 4 cumulative puffs, respectively. There was no significant difference in heart rate between treatments. CONCLUSIONS: Delivery of albuterol through an anti-static chamber provides a clinically relevant improvement in bronchodilator response during acute, reversible bronchospasm such as nocturnal bronchospasm.
Authors: M A Dolovich; N R MacIntyre; P J Anderson; C A Camargo; N Chew; C H Cole; R Dhand; J B Fink; N J Gross; D R Hess; A J Hickey; C S Kim; T B Martonen; D J Pierson; B K Rubin; G C Smaldone Journal: Respir Care Date: 2000-06 Impact factor: 2.258
Authors: Joseph L Rau; Dominic P Coppolo; Mark W Nagel; Valentina I Avvakoumova; Cathy C Doyle; Kimberly J Wiersema; Jolyon P Mitchell Journal: Respir Care Date: 2006-05 Impact factor: 2.258
Authors: J H Wildhaber; S G Devadason; M J Hayden; R James; A P Dufty; R A Fox; Q A Summers; P N LeSouëf Journal: Eur Respir J Date: 1996-09 Impact factor: 16.671