Medicine of the Future in America

Patient Handling of a Multidose Dry Powder Inhalation Device for Albuterol: Withdrawals and Adverse Events

Patient Handling of a Multidose Dry Powder Inhalation Device for Albuterol: Withdrawals and Adverse EventsA total of 540 patients (12 percent) were withdrawn from the study; 50 patients in the pediatric group (8 percent), 363 patients in the adult group (12 percent), and 127 patients in the elderly population (16 percent). Reasons for withdrawal are listed in Table 5. Failure to return was the most often reported reason for withdrawal in both pediatric and adult groups (approximately 4 percent in each), whereas difficulty in use was the most common reasons for withdrawal in the elderly population (5 percent).
A total of 646 adverse events were reported by 491 patients (11 percent); 54 were reported by the 6- to 12-year-old group, 466 events by the 13- to 64-year-old group, and 126 eVents by the 65 years of age and over group. The most frequently reported adverse events were tremor and cough in children and adults: among children, 5 patients (1 percent) reported tremor and 7 reported cough (1 percent); in the adolescent/adult population, 97 patients (3 percent) reported tremor and 54 reported cough (2 percent). Canadian family pharmacy itat on Cough and headache were the most frequently reported adverse events among the elderly; 17 patients (2 percent) reported cough, 11 patients (1 percent) reported headache, and 8 patients (1 percent) reported tremor. A total of 183 patients (4.0 percent) were classified as treatment failures, as indicated by worsening of their asthma while receiving therapy.
A total of 112 patients (2.5 percent) were withdrawn from the study due to adverse events (100 with nonmajor adverse events and 12 with major adverse events). Of the 112 patients withdrawn, 88 patients experienced adverse events considered by the investigator to be “drug related.”
Of the 19 major adverse events reported, only 12 resulted in withdrawal. Three of these major adverse events were considered by the investigator to be “drug related” (ie, assessed as either possibly, probably, or almost certainly drug related). These events were exacerbation of asthma within 48 h of starting therapy, “choking” and elevated blood pressure, and dyspnea and rash. The objectives of this study were to assess the efficacy of albuterol delivered by a multidose dry powder disk system in a large population of patients with reversible airways obstruction being treated in a realistic clinical venue. The medication and device were well tolerated with 11 percent of patients reporting adverse effects; these were generally minor and only infrequently resulted in withdrawal from the study.

Table 5—Summary of Reasons for Withdrawal From the Study

Reason for Withdrawal, No. (%) Age, yr
<13 13-64 >64 Total
Difficult to use 4(0.6) 8(0.3) 40(5.0) 52(1.1)
Disliked device, drug or study 1(0.2) 35(1.1) 20(2.5) 56(1.2)
Exacerbation of asthma 3(0.5) 29(0.9) 7(0.9) 39(0.9)
Failure to return 25(3.7) 137(4.4) 12(1.5) 174(3.8)
Ineffectiveness of drug 4(0.6) 63(2.0) 24(3.0) 91(2.0)
Major adverse event 1(0.2) 6(0.2) 5(0.6) 12(0.3)
Nonmajor adverse event 5(0.7) 66(2.1) 29(3.7) 100(2.2)
Other 10(1.5) 45(1.5) 5(0.6) 60(1.3)
This entry was posted in Pulmonary function and tagged albuterol, asthma, blisters ventodisk, cough, inhaler.
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