Nebuliser performance, pharmacokinetics, airways and systemic effects of salbutamol given via a novel nebuliser delivery system ("Ventstream"). 1994

D M Newnham, and B J Lipworth
Department of Clinical Pharmacology, University of Dundee, Ninewells Hospital and Medical School, UK.

BACKGROUND Currently available nebulisers are inefficient and show variable aerosol deposition in the lung owing to the differences in the particle size generated. The aim of this study was to compare systemic absorption and bronchodilator effects of salbutamol given via a novel ("Ventstream") and a conventional ("Hudson Updraft II") nebuliser system, having initially evaluated the performance of both nebulisers in vitro. The "Ventstream" nebuliser uses a one way valve system to provide an additional inspiratory side flow to match aerosol delivery with tidal volume. METHODS Nebuliser output and particle distribution from 10 Ventstream and 10 Hudson nebulisers were compared in vitro. Eight asthmatic patients, FEV1 55(2)% predicted, were then randomised to receive salbutamol via Ventstream or Hudson nebulisers on separate days. On each day cumulative doses of inhaled salbutamol were given: 1.25 mg, 2.5 mg (1.25 + 1.25 mg), and 5.0 mg (2.5 + 2.5 mg). Airways responses, systemic responses, and plasma salbutamol concentrations were measured at each dose and for up to 240 minutes after the final dose. RESULTS The in vitro comparison showed a greater respirable fraction with a higher percentage volume of particles < 5 microns in diameter using Ventstream than Hudson nebulisers (mean (95% CI) for difference): 25.4% (95% CI 22.4% to 28.3%), and a higher aerosol rate of output: 0.08 g/min (95% CI 0.05 to 0.11 g/min). At the 5.0 mg dose the Ventstream produced a twofold greater concentration of plasma salbutamol than the Hudson nebuliser (AUC0-240): 392.1 ng/ml.min (95% CI 240.6 to 543.6 ng/ml.min). There was a higher AUC0-240 for PEFR with the Ventstream than with the Hudson nebuliser: 74.161 x 10(2) (95% CI 39.50 to 108.821 x 10(2). For FEV1 and FEV25-75 there was a difference in the peak response between the 5.0 mg and 2.5 mg doses with the Ventstream only. Extrapulmonary beta 2 responses were greater with the Ventstream than with the Hudson at 2.5 mg and 5.0 mg doses, although the differences did not appear to be clinically relevant. CONCLUSIONS The Ventstream produced a twofold increase in the delivery of salbutamol to the lung compared with the Hudson nebuliser, and there was an associated increase in systemic beta 2 responses with an improvement in some parameters of bronchodilator efficacy. As a consequence of improved delivery with the Ventstream, it may be possible to halve the drug dose to produce similar bronchodilator efficacy at reduced cost. Further studies are required to evaluate the value of the Ventstream for delivery of nebulised antibiotics and corticosteroids.

UI MeSH Term Description Entries
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D009330 Nebulizers and Vaporizers Devices that cause a liquid or solid to be converted into an aerosol (spray) or a vapor. It is used in drug administration by inhalation, humidification of ambient air, and in certain analytical instruments. Atomizers,Inhalation Devices,Inhalators,Inhalers,Vaporizers,Nebulizers,Vaporizers and Nebulizers,Atomizer,Device, Inhalation,Devices, Inhalation,Inhalation Device,Inhalator,Inhaler,Nebulizer,Vaporizer
D010366 Peak Expiratory Flow Rate Measurement of the maximum rate of airflow attained during a FORCED VITAL CAPACITY determination. Common abbreviations are PEFR and PFR. Expiratory Peak Flow Rate,Flow Rate, Peak Expiratory,PEFR
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D000420 Albuterol A short-acting beta-2 adrenergic agonist that is primarily used as a bronchodilator agent to treat ASTHMA. Albuterol is prepared as a racemic mixture of R(-) and S(+) stereoisomers. The stereospecific preparation of R(-) isomer of albuterol is referred to as levalbuterol. Salbutamol,2-t-Butylamino-1-(4-hydroxy-3-hydroxy-3-hydroxymethyl)phenylethanol,Albuterol Sulfate,Proventil,Sultanol,Ventolin
D001249 Asthma A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL). Asthma, Bronchial,Bronchial Asthma,Asthmas
D013147 Spirometry Measurement of volume of air inhaled or exhaled by the lung. Spirometries
D016503 Drug Delivery Systems Systems for the delivery of drugs to target sites of pharmacological actions. Technologies employed include those concerning drug preparation, route of administration, site targeting, metabolism, and toxicity. Drug Targeting,Delivery System, Drug,Delivery Systems, Drug,Drug Delivery System,Drug Targetings,System, Drug Delivery,Systems, Drug Delivery,Targeting, Drug,Targetings, Drug

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