The Science Journal of the American Association for Respiratory Care

1996 OPEN FORUM Abstracts

CLINICAL COMPARISON OF A NEW ULTRASONIC NEBULIZER WITH AN MDI/HOLDING CHAMBER.

R.J. Perry B.S., E.G. Langenback Ph.D. and S.A. Vitkun M.D. Departments of Medicine and Anesthesiology, SUNY at Stony Brook, Stony Brook, NY 11794.

Aerosol therapy has proven to be an effective modality in the treatment of asthma. However, many aerosol devices are developed, bench tested for equivalence with current devices and become available to patients without clinical efficacy data. The present study compares the clinically accepted Aerochamber (r) (AC) with a new handheld ultrasonic nebulizer, the De Vilbiss Pulmosonic^{TM}(PS), both combined with albuterol and administered to asthmatics. To enter the protocol a subject first demonstrated a bronchodilator response of at least 15% (increase in FEV1) to a Ventolin(r)(VT) unit dose (2.5mg albuterol/ 3ml saline) via jet nebulizer. On separate study days 3 subjects inhaled 2 puffs of VT MDI (90 \muq albuterol/puff) through the AC or VT unit dose via PS after withholding all asthma medications for 8 hours. Spirometry was performed before and 30, 60, 120, 180 and 240 minutes after bronchodilator treatment using a Puritan Bennett Renaissance^{TM} spirometry system. Pulse, blood pressure and incidence of side effects were also recorded. Bronchodilation was assessed by evaluating changes in FEV1 using a "% possible" index which normalizes for differences in the baseline FEV1 between study days. \delta FEV1%P is defined as the difference between the baseline FEV1 and each post bronchodilator FEV1 divided by the difference between the predicted FEV1 and the baseline FEV1 and was calculated for all time points. Mean \deltaFEV1%P ± S.E. at T=30, 60, 120, 180 and 240 minutes were as follows. PS: 37.8±5.9, 45.1±6.0, 45.2±10.0, 39.5±9.9, 33.9±11.7 and AC: 35.3±7.7, 39.6±11.0, 31.8±11.6, 18.5±10.6. This data verifies the effectiveness of the PS/VT combination in asthmatics. The greater \deltaFEV1%P observed at 240 minutes (p=0.02, paired t-test) in the PS over the AC may be explained by differences in drug dosage delivered by the devices. The PS nebulizer may be more effective because it delivered a higher dose of albuterol to the lung resulting in a prolonged efficacy compared to the AC system. Further evaluation will determine if the PS will allow patients to maintain adequate bronchodilation with fewer treatments per day.

Reference: OF-96-093

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