The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
MAY 18 2026
APPROVED · 74 DAYS AGO

Chiesi USA, Inc. Trimbow (beclomethasone/formoterol/glycopyrrolate)

for maintenance treatment of asthma

NDA

FDA approved Trimbow (beclomethasone/formoterol/glycopyrrolate) inhaler for maintenance treatment of asthma.

About

Asthma is a chronic inflammatory disease of the airways that causes recurring episodes of wheezing, coughing, and shortness of breath, which can suddenly worsen and restrict oxygen flow. Trimbow is an inhaler that combines three medicines: an anti-inflammatory steroid, a long-acting bronchodilator to open airways, and a second type of bronchodilator that further prevents airway constriction. This triple combination may provide more comprehensive control of the underlying inflammation and muscle tightening that drive asthma symptoms.

Pivotal trial

Triskel Phase 2 completed NCT02127866

Primary objective The primary objective was to evaluate the efficacy of a free combination of CHF 5259 at 3 dose levels plus Foster® 100/6 μg in a pMDI by comparison with Foster® 100/6 μg in terms of forced expiratory volume in the first second (FEV1) area under the curve between time 0 and 12 hours (AUC0-12h) normalised by time on Day 42. Key secondary objective The key secondary objective was to evaluate the efficacy of the free combination CHF 5259 plus Foster® 100/6 μg by comparison wit...

Source: ClinicalTrials.gov

Also in development