Differences in baseline characteristics between the ICS and placebo groups were assessed using t tests for continuous variables and x2 tests for categoric variables. Differences in the rates of new or worsening skin conditions were compared using the Wilcoxon rank-sum test.
The probabilities of reporting bruising or slow healing at some time during the study were analyzed according to the intention-to-treat principle. A logistic regression model was fit to assess the effect of treatment assignment on the probability of participants reporting bruising, adjusted for baseline age, gender, and interaction terms. Significant two-way and three-way interactions were present, which prevented reporting odds ratios of the covariates, and thus parameter estimates and p values are presented. Similar analyses were used for slow healing, although fewer covariates were entered into the final analysis. We also examined the effect of treatment on bruising and slow healing by compliance group.
Differences in the proportions of participants reporting any bruising or reporting bruising > 25% of the time between treatment groups and compliance categories were assessed using X2 tests. Good and poor compliance categories were defined by an average use of six puffs or more per day and less than six puffs per day, respectively, based on canister weights. Differences in the proportion of participants reporting bruising among those who experienced large declines in BMD were assessed using Fisher exact test.
A p value of < 0.05 was considered to be statistically significant. The reported p values are two-sided, and the p values for comparisons of treatment groups have not been adjusted for multiple comparisons. life without allergy
Table 1 shows the baseline characteristics of the study sample. A more detailed description has been published elsewhere. The TAA and placebo groups appear to be well-balanced following randomization, and no statistically significant differences were noted between the two groups in any of the listed baseline characteristics.
Table 1—Selected Baseline Characteristics of the 1,116 Study Participants
|Characteristics||Triamcinolone (n = 544)||Placebo (n = 542)|
|Age, yr||56.1 (6.7)||56.4 (6.8)|
|Female gender, %||36.2||38.2|
|Non-white race, %||6.3||4.2|
|Mean cigarettes/day (among smokers)||22.8(12.2)||24.0(13.1)|
|Mean FEVj before bronchodilator, L||2.16 (0.62)||2.10 (0.64)|
|Mean FEV1, % predicted||64.8 (13.4)||63.4 (13.2)|
|Reported sun exposure, h/wkf||8.10(10.5)||7.8 (10.8)|
|ASA/NSAID use, % participants||9.6!||11.4!|