Long-term effects of inhaled budesonide on screening-detected lung nodules

ABSTRACT

We evaluated the long-term outcomes of a randomized, double-blind, placebo-controlled phase IIb trial of inhaled budesonide in 202 current and former smokers with persistent CT-detected lung nodules. Budesonide significantly decreased the size of non-solid nodules after 5 years. This is of potential importance since some of these nodules may progress slowly to adenocarcinoma.

Background

A previously carried out randomized phase IIb, placebo-controlled trial of 1 year of inhaled budesonide, which was nested in a lung cancer screening study, showed that non-solid and partially solid lung nodules detected by low-dose computed tomography (LDCT), and not immediately suspicious for lung cancer, tended to regress. Because some of these nodules may be slow-growing adenocarcinoma precursors, we evaluated long-term outcomes (after stopping the 1-year intervention) by annual LDCT.

Patients and methods

We analyzed the evolution of target and non-target trial nodules detected by LDCT in the budesonide and placebo arms up to 5 years after randomization. The numbers and characteristics of lung cancers diagnosed during follow-up were also analyzed.

Results

The mean maximum diameter of non-solid nodules reduced significantly (from 5.03mm at baseline to 2.61mm after 5 years) in the budesonide arm; there was no significant size change in the placebo arm. The mean diameter of partially solid lesions also decreased significantly, but only by 0.69 mm. The size of solid nodules did not change. Neither the number of new lesions nor the number of lung cancers differed in the two arms.

Conclusions

Inhaled budesonide given for 1 year significantly decreased the size of non-solid nodules detected by screening LDCT after 5 years. This is of potential importance since some of these nodules may progress slowly to adenocarcinoma. However, further studies are required to assess clinical implications.

Clinical trial number

NCT01540552.