Drug Update · Pulmonology

FDA Approves Trimbow for Maintenance Treatment of Asthma

August 29, 2026

Approval date

05/14/2026

Indication

Maintenance treatment of asthma in adult patients aged 18 years and older

Primary efficacy (TRIMARAN)

TRIMBOW vs BDP/FF difference in LS means in trough FEV1 at Week 26: 57 mL (95% CI: 15, 99)

Primary efficacy (TRIGGER)

TRIMBOW vs BDP/FF difference in LS means in trough FEV1 at Week 26: 73 mL (95% CI: 26, 120)

Clinical Perspective

For pulmonologists, respiratory medicine specialists, and pharmacists treating adults with asthma, the FDA approval provides an FDA-labeled, fixed-dose triple inhaler (ICS/LABA/LAMA) option for maintenance therapy in patients aged 18 years and older ^[2]^[1]. The prescribing information supports two recommended dosing regimens and specifies administration, priming, and device handling details that clinicians should follow ^[1]^[3]. Direct comparative effectiveness versus other triple- and dual-inhaler products was not reported in the provided source excerpts; what remains unanswered is which patient subgroups will derive the greatest incremental clinical benefit from a fixed triple combination versus separate or alternative combination inhalers?

Dr. Nikhil Chatterjee, MBBS, MD (Respiratory Medicine) · Pulmonology

Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate) was approved by the FDA for the maintenance treatment of asthma in adults aged 18 years and older, effective 05/14/2026 ^[2]. The approval and labeling describe randomized, double-blind, active-controlled trials (TRIMARAN and TRIGGER) that evaluated lung-function and symptom outcomes versus beclomethasone dipropionate/formoterol fumarate (BDP/FF) ^[4]^[1].

Clinical Context

Trimbow is a fixed-dose triple-combination inhalation aerosol that contains beclomethasone dipropionate (an inhaled corticosteroid), formoterol fumarate (a long-acting beta2-adrenergic agonist), and glycopyrrolate (an anticholinergic) ^[1]^[4]. The product is supplied and marketed by Chiesi (Chiesi Farmaceutici S.p.A. / Chiesi USA, Inc.) and received FDA approval under NDA 219622 ^[2]^[3]. The prescribing information describes priming, dosing strengths, and storage; the approval letter sets an expiry dating period of 18 months from the date of manufacture when stored at 5°C ±3°C ^[1]^[2]. Direct head-to-head comparisons with other triple- or dual-inhaler products (for example, Trelegy Ellipta or Breztri Aerosphere) were not reported in the provided source excerpts.

Key Findings

The FDA approval references two randomized, double-blind, parallel-group, active-controlled 52-week trials, TRIMARAN and TRIGGER, which formed the efficacy basis for approval ^[4]. The trials measured mean change from baseline in trough FEV1 at Week 26 as a primary lung-function endpoint ^[4]. In TRIMARAN (intent-to-treat population reported), TRIMBOW at the 172 mcg/9.8 mcg/21.2 mcg dose showed a least-squares (LS) mean change in trough FEV1 of 185 mL (95% CI: 155, 214) versus 127 mL (95% CI: 98, 157) for BDP/FF, giving a difference in LS means of 57 mL (95% CI: 15, 99) ^[4]. Clinicians should consult current prescribing information for full dosing guidance. In TRIGGER, TRIMBOW at the 344 mcg/9.8 mcg/21.2 mcg dose showed an LS mean change of 229 mL (95% CI: 196, 263) versus 157 mL (95% CI: 123, 190) for BDP/FF, a difference in LS means of 73 mL (95% CI: 26, 120) ^[4]. At Week 52, ACQ-7 responder rates (≥0.5 decrease from baseline) were 61% and 62% for TRIMBOW 172/9.8/21.2 mcg and 344/9.8/21.2 mcg, respectively, compared with 59% and 58% for the corresponding BDP/FF groups, with odds ratios of 1.07 (95% CI: 0.84, 1.36) and 1.12 (95% CI: 0.94, 1.32) ^[4]. These trial results are described in the prescribing information and were part of the FDA review ^[4]^[1].

Safety & Tolerability

Most common adverse reactions (incidence ≥ 1%) reported in the prescribing information are bronchitis, hypertension, back pain, blood pressure increased, dysphonia, upper respiratory tract infection, influenza, anemia, muscle spasms, laryngitis, oropharyngeal pain, and sinusitis ^[1]^[3].

Study Design

The efficacy evidence for approval came from two randomized, double-blind, parallel-group, active-controlled 52-week trials named TRIMARAN (NCT02676076) and TRIGGER (NCT02676089) in adults with uncontrolled asthma despite medium- or high-dose ICS plus LABA therapy ^[4]. The pooled efficacy population comprised 2,291 patients (TRIMARAN N = 1,149; TRIGGER N = 1,142) who received at least one dose and had at least one post-baseline efficacy evaluation; the primary lung-function endpoint was mean change from baseline in trough FEV1 at Week 26 ^[4]. The NDA (219622) was approved by FDA and the approval letter cites labeling and postmarketing pediatric study requirements under PREA ^[2].

FAQ

Q1 What is Trimbow approved for?

Trimbow is approved for the maintenance treatment of asthma in adult patients aged 18 years and older. The approval specifies that Trimbow is not indicated for relief of acute bronchospasm and should be used as maintenance therapy in adults with asthma.

Q2 How does Trimbow work?

Trimbow combines three pharmacologic classes: beclomethasone dipropionate (an inhaled corticosteroid) with anti-inflammatory effects, formoterol fumarate (a long-acting beta2-adrenergic agonist) acting as a bronchodilator, and glycopyrrolate (a long-acting antimuscarinic/anticholinergic) that contributes bronchodilation via muscarinic receptor inhibition; the label includes mechanistic descriptions for each component.

Q3 What is the recommended dose of Trimbow?

The prescribing information lists recommended dosing options for adults: TRIMBOW 172 mcg/9.8 mcg/21.2 mcg administered as 2 actuations of TRIMBOW 86 mcg/4.9 mcg/10.6 mcg twice daily, or TRIMBOW 344 mcg/9.8 mcg/21.2 mcg administered as 2 actuations of TRIMBOW 172 mcg/4.9 mcg/10.6 mcg twice daily; the label also describes priming, dose counter behavior, and maximum recommended dose. Clinicians should consult current prescribing information for complete dosing guidance.

Q4 What are the most common side effects?

The most common adverse reactions reported in the prescribing information with incidence ≥ 1% include bronchitis, hypertension, back pain, blood pressure increased, dysphonia, upper respiratory tract infection, influenza, anemia, muscle spasms, laryngitis, oropharyngeal pain, and sinusitis. The label also contains warnings and precautions including risks related to LABA use, oropharyngeal candidiasis, potential effects on adrenal function, and cautions in certain comorbidities; clinicians should refer to the full prescribing information for monitoring and management details.

Clinicians should consult current prescribing information for complete dosing guidance.

FDA Approves Trimbow for Maintenance Treatment of Asthma

Direct Clinical Takeaway & Evidence Summary

FDA Approves Trimbow for Maintenance Treatment of Asthma

Clinical Perspective

Clinical Context

Key Findings

Safety & Tolerability

Study Design

FAQ

References

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