Takeaway
- In patients with moderate or severe acute exacerbation of chronic obstructive pulmonary disorder (COPD), the addition of nemiralisib to standard-of-care treatment for 12 weeks did not improve lung function compared with placebo.
- Furthermore, nemiralisib had no effects on the rate of re-exacerbation, recovery from the index exacerbation or patient health status associated with exacerbation recovery.
Why this matters
- Patients with acute exacerbations of COPD often have an unmet treatment need.
Study design
- A multicentre, double-blind, placebo-controlled study of 938 patients with COPD who were randomly assigned to receive placebo (n=276) or nemiralisib 12.5 μg (n=22), 50 μg (n=91), 100 μg (n=92), 250 μg (n=90), 500 μg (n=89) or 750 μg (n=278; ratio of 3:1:1:1:1:1:3) for 12 weeks with an exploratory 12-week follow-up period.
- Primary outcome: change in post-bronchodilator forced expiratory volume in 1 second (FEV1) at 12 weeks.
- Funding: GlaxoSmithKline.
Key results
- No difference was seen in the change from baseline FEV1 at week 12 between the nemiralisib 750 μg and placebo groups (posterior adjusted median difference, −0.004L; 95% credible interval, −0.051L to 0.042L).
- Overall, no differences were seen in exacerbation rates, Exacerbations of Chronic Pulmonary Disease Tool (EXACT)-defined recovery at 28 days and in the time to EXACT-defined recovery, COPD Assessment Test and St George's Respiratory Questionnaire for COPD between the nemiralisib and placebo groups.
- The most common adverse event was cough, with a higher incidence reported in the nemiralisib 500 μg (35%) and 750 μg (35%) groups than in the placebo group (5%).
Limitations
- Procalcitonin has been identified as a potential marker of bacterial exacerbations of COPD, though its ability to discriminate may be moderate.
This clinical summary originally appeared on Univadis, part of the Medscape Professional Network.
