An attempt was made to enlist the participation of physicians from all geographic regions of Canada. Physicians could be primary care physicians or specialists, in private or academic practice, practicing in a group or independently, and working with or without a nurse or other individual counseling patients in the correct use of inhaling devices. Physicians were asked to complete a clinical record form for each of ten asthmatic patients enrolled into the study over the recruitment period of 20 months.
Patients were eligible to participate in the study if they were 6 years of age or older, had stable obstructive lung disease as diagnosed by their physicians, and used an inhaled 02-agonist at the time of recruitment. Patients were excluded if they had previously used the multidose dry powder inhaler system and if there was a history of significant cardiovascular, endocrine, hepatic, or renal impairment. Women who were pregnant or of childbearing potential and not using adequate contraception were also excluded.
The study was an open design of 2 weeks’ duration. Dosage was assigned in a nonrandom manner at the discretion of the physician. Patients were prescribed an appropriate dosage of salbutamol that reflected their normal daily dosage regimen of inhaled 02-agonist. Asthma inhalers online itat on If the patient was using the albuterol dry powder capsules (Rotacap), the dosage of salbutamol remained the same. If the patient was using an albuterol metered-dose inhaler (MDI), twice the microgram dosage was administered in disk format up to a daily maximum of 1,600 fig in adults (4 blisters Ventodisk, 400 fig, or 8 blisters Ventodisk, 200 Mg/d) and 800 fig in children (4 blisters Ventodisk, 200 Mg/d). The proper use of the device (Tables 1 and 2) was demonstrated to all patients who in turn were asked to demonstrate their ability to use it. Patients were requested to take all other regular medications for asthma or for other conditions as prescribed. At the end of the 2 weeks, patients were asked to demonstrate their ability to use the disk device and to evaluate it on the basis of whether or not they preferred it over the previously used device. Patients were also asked whether they had experienced any medical problems since the previous visit. All adverse experiences and intercurrent illnesses occurring during the course of the trial were recorded as adverse events, regardless of the apparent relationship to study treatment. Patients were asked if they had taken the study medication as prescribed. Reasons for noncompliance were noted in the case record form and, if appropriate, were documented as adverse events. A major adverse event was defined as either death, life-threatening events, disabling or incapacitating events, or events requiring or prolonging hospitalization.
Table 1—Ability to Use the Disk System of the Initial Visit
|Step||Attempt, No. (%)|
|Remove mouthpiece cover||3,992(87)||505(11)||39(1)||6(0)||30(1)|
|Load disk into Diskhaler||3,371(74)||1,031(23)||123(3)||15(0)||32(1)|
|Inhale from device||3,854(84)||613(13)||58(1)||16(0)||31(1)|
|Rotate disk to next blister||3,599(79)||845(19)||78(2)||16(0)||34(1)|
|Clean the device||4,158(91)||339(7)||29(1)||5(0)||41(1)|
Table 2—Ability to Use the Disk System After 2 Weeks of Treatment
|Step||Attempt, No. %|
|Remove mouthpiece cover||4,246(94)||9(0)||274(6)|
|Load disk into Diskhaler||4,208(93)||48(1)||273(6)|
|Inhale from device||4,205(93)||50(1)||274(6)|
|Rotate disk to next blister||4,213(93)||41(1)||275(6)|
|Clean the device||4,130(91)||102(2)||297(7)|