Biomaterial Database

A comparative bronchodilator study of salbutamol and salbutamol sulphate that were administered by metered-dose inhalers. 1989

R E Ruffin, and K M Latimer, and A J Crockett, and M M Blight

Department of Respiratory Medicine, Flinders Medical Centre, Bedford Park.

Twenty-one patients with mild-to-moderately-severe asthma participated in a placebo-controlled, double-blind, cross-over, randomized bronchodilator study of 200 micrograms of salbutamol (Glaxo) and 200 micrograms of salbutamol in the form of salbutamol sulphate (Riker; 50-microL and 25-microL valves) that were administered by metered-dose inhalers. The mean baseline forced expired volumes in one second (FEV1) were similar for the four separate study days. The three active treatments caused a significantly-greater FEV1 response than did placebo for four hours (P less than 0.05) and no difference was found between the treatments (P greater than 0.05). The power of the study was 75% with a clinically-significant difference in the FEV1 response of 25%. The administration of 200 micrograms of salbutamol (Glaxo) caused the same FEV1 response as did that of 400 micrograms of salbutamol at the end of that study day (P greater than 0.05), but both 200-micrograms doses of salbutamol sulphate (Riker) caused a smaller FEV1 response than did the 400 micrograms of salbutamol sulphate (P less than 0.05). These observations indicate that no clinically-significant difference occurs between the bronchodilator effects of salbutamol and those of salbutamol sulphate which is administered as 200 micrograms of salbutamol equivalent, with different propellant mixtures, dispersal agents and valvular systems.

UI	MeSH Term	Description	Entries
D008297	Male		Males
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
D011897	Random Allocation	A process involving chance used in therapeutic trials or other research endeavor for allocating experimental subjects, human or animal, between treatment and control groups, or among treatment groups. It may also apply to experiments on inanimate objects.	Randomization,Allocation, Random
D012129	Respiratory Function Tests	Measurement of the various processes involved in the act of respiration: inspiration, expiration, oxygen and carbon dioxide exchange, lung volume and compliance, etc.	Lung Function Tests,Pulmonary Function Tests,Function Test, Pulmonary,Function Tests, Pulmonary,Pulmonary Function Test,Test, Pulmonary Function,Tests, Pulmonary Function,Function Test, Lung,Function Test, Respiratory,Function Tests, Lung,Function Tests, Respiratory,Lung Function Test,Respiratory Function Test,Test, Lung Function,Test, Respiratory Function,Tests, Lung Function,Tests, Respiratory Function
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260	Female		Females
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