The analysis for the correct use of the device at the initial visit was performed based on all patients enrolled into the study (n=4,572). All the other analyses were based on those patients who were eligible and demonstrated correct use of the device at the initial visit (n=4,529). Canadian health care mall itat on Fisher’s exact test was used for comparisons among the three age groups (<13 years, 13 to 64 years, >64 years) for adverse events, treatment failures, device preference, and ability to perform the six disk device-handling steps correctly at the initial visit and after 2 weeks. The analyses of overall device preference for all age groups and for all previous device groups were performed using the sign test. Data are expressed as proportions or means ±SD. Statistical significance was considered when p<0.05.
A total of 4,572 patients were screened. Forty-three patients were excluded at the initial screening for a variety of nonmedical and nondevice (0.9 percent) reasons (ie, inability to return in 2 weeks for follow-up assessment). Of the 4,572 patients, 49 percent were male and 51 percent were female. The mean age was 39 ± 22 years; 15 were younger than 6 years, 653 were between the ages of 6 and 12 years, 3,110 were between the ages of 13 and 64 years, and 793 were patients older than 64 years. Age was not specified in one patient. The mean duration of obstructive lung disease was 11 years. Fifty-five percent of the patients were nonsmokers while 45 percent were either exsmokers or present smokers. Only two patients were considered to have severe hand problems which could have affected their handling of the disk device.
At the time of recruitment, 78 percent of patients were using an MDI alone and 5 percent were using an MDI with a spacer attachment. Other dry powder inhalers (Rotacap) were used by 11 percent of the patients. A nebulizer was used by 161 patients. The remaining patients (n=101) used more than one device prior to the study.
Approximately 56 percent of subjects were assigned to use the disk device four times a day, 11 percent three times a day, 9 percent twice a day, 1 percent once daily, and 21 percent stated they used it as needed. A total of 41 percent of patients were taking concurrent inhaled corticosteroids.