Efficacy and safety were assessed by regular visits to the clinic, and followed up by telephone calls.
Results showed that after 168 days of treatment, ALIS was not inferior to TIS in effects on lung function — patients treated with TIS showed improved FEV1 levels of 2.87% over baseline, while those in the ALIS treatment group improved by 1.56%. The difference between ALIS and TIS treatments was -1.31%; which is within the 5% limit that indicates the ALIS treatment was similar in efficacy to TIS (meaning non-inferior).
Regarding the different cycles, at the end of the first treatment cycle (day 28), TIS treatment improved FEV1 by 7.32%, while the ALIS group showed an improvement of 4.39%. These same comparative improvements were also demonstrated at the end of the second cycle (day 84), and the third cycle (day 140).
These improvements were consistent across all demographic subgroups regardless of age, sex, or ethnicity.
In addition, both treatments also showed clinically meaningful improvements in CFQ-R Respiratory Symptoms scores at the end of cycle 1.
Reductions in the number of P. aeruginosa bacteria in sputum were also similar between the ALIS and TIS treatment groups at the end of the treatment period, compared to baseline.
The safety of ALIS and TIS treatments were also similar. In both groups, most patients experienced more than one mild or moderate treatment-emergent adverse event (TEAE) — 84.5% in ALIS vs. 78.8% in TIS. Most of the side effects were respiratory events and exacerbations.
The number of TEAEs in the ALIS group (52.0%) was higher than in the TIS group (34.6%) after the first treatment cycle, but progressively decreased (to 39.6%) during the study to levels similar to the TIS group (37.4%).
“Patients reported improvement in their respiratory symptoms and had a lower treatment burden as measured by CFQ-R, with trends in favor of ALIS compared with TIS despite a higher frequency of pulmonary exacerbations reported in the ALIS arm,” the researchers said.
Altogether, the results demonstrated that once-daily ALIS treatment for P. aeruginosa infection had similar outcomes to the standard twice-daily treatment with TIS, showing improvements in lung function, and reduction in the number of P. aeruginosa bacteria in sputum, regardless of age, sex, or ethnicity.
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