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  • Ketotifen in the Prophylaxis of Extrinsic Bronchial Asthma: Results

Ketotifen in the Prophylaxis of Extrinsic Bronchial Asthma: ResultsStatistical Analysis
According to the type and distribution of the data, either parametric tests (Students f-test) or nonparametric analyses (Wil-coxon-Mann-Whitney U-test) were utilized. In x* tests, “n-1” replaced “n” in the formula used for continuity correction of 2 x 2 tables. The level of significance was defined with alpha=0.05 (two-sided tests), but if the difference was close to the significance level, x2 values were calculated also by the C-test of Woolf. canadian health&care mall

Results
Characteristics of Patients

The study comprised 255 patients, 131 male and 124 female patients similarly distributed between the two study groups. The proportion of male patients was 54 percent in the group receiving slow-release oral ketotifen, compared to 49 percent in the group receiving placebo. The mean ages were 24 years (slow-release oral ketotifen) and 23 years (placebo), with a range from 6 to 51 years. The majority of patients were outpatients (slow-release oral ketotifen, 80 percent; placebo, 82 percent). All patients had mild or moderate bronchial asthma, with a median duration of 5.5 years in the group receiving slow-release oral ketotifen (range, 0 to 27 years) and 5.8 years in the group receiving placebo (range, 0 to 32 years). The majority of patients suffered from extrinsic bronchial asthma (slow-release oral ketotifen, 94 percent; placebo, 95 percent) and the remainder suffered from mixed types (slow-release oral ketotifen, 6 percent; placebo, 4 percent) (Table 1). Asthma was not sufficiently characterized for classification in 0.8 percent of either group. Two patients withdrew from the study for reasons unrelated to the tested medication or disease and were considered dropouts. In addition, the results from four patients with serious violations of protocol were considered invalid. There was a subgroup of ten patients in whom a prior history of steroid therapy for asthma was identified only after completion of the study. Such patients are excluded by the entry criteria into this study. Hence, their data were excluded only for all measurements of efficacy. Evaluations of efficacy are therefore based on a reduced number of patients, 124 of them having been randomized to the group with slow-release oral keto-tifen and 121 to the group with placebo. After 12 weeks, 229 patients remained for statistical analysis (Table 2).
Table 1—Symptoms, Tests, and Smoking Habits Four Weeks Prior to Study

Data and Group No. of Cases Percent with Answer, “Yes”
Cough
Ketotifen SRO 124 80
Placebo 121 77
Sputum
Ketotifen SRO 123 36
Placebo 121 42
Nasal obstruction
Ketotifen SRO 124 61
Placebo 119 64
Nasal discharge
Ketotifen SRO 124 54*
Placebo 120 65*
Runny eyes
Ketotifen SRO 123 30
Placebo 119 29
Atopic eczema
Ketotifen SRO 124 19*
Placebo 120 11*
Asthmatic attacks
Ketotifen SRO 124 97
Placebo 121 96
Positive skin test to
known allergens
Ketotifen SRO 124 94
Placebo 121 98
Bronchial allergen challenge
Ketotifen SRO 124 24
Placebo 121 25
Exposure to smoke
A dive smoker
Ketotifen SRO 113 9
Placebo 108 9
Passive smoker
Ketotifen SRO 108 37
Placebo 99 42

Table 2—Patients Not Evaluated for Efficacy after 12 Weeks

Data Ketotifen* Placebo Total
No. of patients 132 129 261
Dropouts 2 4 6
No. with oral
corticosteroidsf 6 (5+It) 4 (3+1§) 10 (8 + 2)
Premature termination
Ineffectiveness 0 2 2
Side effects 4 1 5
Other reasons 3 8 11
Evaluation of efficacy
after 12 wk 118 111 229
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