Azithromycin for Bronchial Asthma in Adults
Azithromycin for Bronchial Asthma in Adults
Of 304 adult asthma patients screened, 97 (32%) were enrolled (38 were randomized to azithromycin, 37 were randomized to placebo, and 22 elected OL treatment). An additional 67 of 304 screened patients (22%) who were otherwise eligible lacked pulmonary function data and could not complete the screening process (Figure 1).
(Enlarge Image)
Figure 1.
CONSORT diagram. *Unavailable pulmonary function tests (PFTs) as the only disqualification of 67 of 170. Nonqualifying PFTs in 10 of 24.
Self-reported mean adherence to taking azithromycin or placebo ranged from 96% to 99%, with no significant differences among the 3 study groups (P = .706). Adherence to reporting follow-up data ranged from 63 of 97 participants (65%) at 12 weeks to 57 participants (59%) at 48 weeks, with no significant differences between study groups (P = .122).
Table 2 presents the patient characteristics. The study group was mostly white and non-Hispanic with a high school education or greater and a broad range of age at asthma onset. The randomized groups were well balanced in major baseline characteristics (age, sex, smoking status, education, and asthma severity), but the group randomized to azithromycin reported more asthma onset after an acute respiratory illness ("infectious asthma") and less use of controller medication compared with the placebo group. Compared with the randomized groups, the OL cohort had significantly greater asthma severity at baseline (more hospitalizations for asthma, greater day and night symptom frequency, worse overall asthma symptoms, and worse asthma quality of life [AQL]); more adult-onset asthma; more chronic sinusitis; more allergy testing (but fewer positive tests); and more infectious asthma. Of the baseline covariates in RM ANOVAs, smoking was significantly associated with worse symptoms, AQL, and asthma control (P < .05 for each); older age was significantly associated only with worse AQL (P < .05), and sex was not significant in any analysis.
Results
Screening and Enrollment
Of 304 adult asthma patients screened, 97 (32%) were enrolled (38 were randomized to azithromycin, 37 were randomized to placebo, and 22 elected OL treatment). An additional 67 of 304 screened patients (22%) who were otherwise eligible lacked pulmonary function data and could not complete the screening process (Figure 1).
(Enlarge Image)
Figure 1.
CONSORT diagram. *Unavailable pulmonary function tests (PFTs) as the only disqualification of 67 of 170. Nonqualifying PFTs in 10 of 24.
Adherence
Self-reported mean adherence to taking azithromycin or placebo ranged from 96% to 99%, with no significant differences among the 3 study groups (P = .706). Adherence to reporting follow-up data ranged from 63 of 97 participants (65%) at 12 weeks to 57 participants (59%) at 48 weeks, with no significant differences between study groups (P = .122).
Baseline Characteristics
Table 2 presents the patient characteristics. The study group was mostly white and non-Hispanic with a high school education or greater and a broad range of age at asthma onset. The randomized groups were well balanced in major baseline characteristics (age, sex, smoking status, education, and asthma severity), but the group randomized to azithromycin reported more asthma onset after an acute respiratory illness ("infectious asthma") and less use of controller medication compared with the placebo group. Compared with the randomized groups, the OL cohort had significantly greater asthma severity at baseline (more hospitalizations for asthma, greater day and night symptom frequency, worse overall asthma symptoms, and worse asthma quality of life [AQL]); more adult-onset asthma; more chronic sinusitis; more allergy testing (but fewer positive tests); and more infectious asthma. Of the baseline covariates in RM ANOVAs, smoking was significantly associated with worse symptoms, AQL, and asthma control (P < .05 for each); older age was significantly associated only with worse AQL (P < .05), and sex was not significant in any analysis.
