Researchers presented results at ATS 2024 for three clinical trials related to mycobacterium avium complex disease and pharmacological therapies for COPD.
The three clinical trials included:
- The ARISE Study on amikacin liposome inhalation suspension in adults with mycobacterium avium complex disease,
- Tezepelumab for moderate to very severe COPD (Phase 2A COURSE study), and
- Dupilumab in patients with moderate to severe COPD (Phase 3 NOTUS trial).
ARISE Study
The ARISE study was designed to evaluate the validity and responsiveness of the quality of life-bronchiectasis questionnaire respiratory domain (QOL-B RD) in patients with mycobacterium avium complex disease (MACLD), which often complicates chronic respiratory diseases such as COPD and bronchiectasis.
Adult patients with new or recurrent MACLD were randomized to receive either amikacin liposome inhalation suspension or placebo for six months. Patients in both groups also received azithromycin and ethambutol.
QOL-B RD showed strong reliability, validity and responsiveness to assessing respiratory symptoms.
Phase 2a COURSE Study
Study participants were those with moderate-to-very severe COPD who had two or more exacerbations in the previous 12 months despite receiving stable triple inhaled therapy. They were randomized to receive tezepelumab with triple therapy or triple therapy alone for 52 weeks. The trial included COPD patients with a broad range of baseline blood eosinophil counts (BEC) and, irrespective of emphysema, chronic bronchitis or smoking status.
Tezepelumab resulted in a nonsignificant 17 percent reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52. In patients with a blood eosinophil count higher than 150 cells/µL, tezepelumab led to a nominally significant reduction of 37 percent in the rate of moderate or severe exacerbations compared to placebo. In patients with BEC ≥300 cells/µL tezepelumab led to a numerical reduction of 46 percent in the rate of moderate or severe exacerbations. Improvements in markers of lung function and quality of life were also observed in these patients.
Phase 3 NOTUS Trial
NOTUS, a randomized, double-blind phase 3 trial of dupilumab versus placebo in adult patients with moderate or severe COPD and type 2 inflammation. The researchers aimed to identify new therapies to target exacerbations which continue to plague many patients.
Dupilumab is a monoclonal antibody that blocks the receptor for interleukin-4 and interleukin-13, key drivers of type 2 inflammation.
At the end of 52 weeks of treatment, the annualized rate of moderate or severe COPD exacerbations was 34 percent lower in the dupilumab group than in the placebo group. This benefit was seen across subgroups, including gender, age, and smoking status. Dupilumab also improved markers of lung function and quality of life.
