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Pulmonology CM-INS-028 // MARCH 2026

COPD Clinical Trials 2026: New Inhalers, Anti-Inflammatory Biologics & Lung Repair

Medical Notice

This article is for informational purposes only and does not constitute medical advice. Clinical trial eligibility and availability vary. Always consult a qualified healthcare professional before making any medical decisions or considering participation in a clinical trial.

Summary

Chronic obstructive pulmonary disease (COPD) affects over 300 million people globally and is the third leading cause of death. Until recently, treatment was largely limited to bronchodilators and inhaled steroids that manage symptoms but don't modify disease progression. In 2026, biologics targeting the inflammatory pathways driving COPD — particularly in patients with eosinophilic inflammation — have reached late-stage trials, and dupilumab received FDA approval for COPD in 2024. This marks a new era for COPD treatment.

Dupilumab for COPD: A Breakthrough

Dupilumab (Dupixent) — already approved for asthma, atopic dermatitis, and other type 2 inflammatory conditions — was approved for COPD with type 2 inflammation (eosinophil count ≥300 cells/μL) in September 2024. The BOREAS and NOTUS Phase 3 trials showed a 30% reduction in exacerbations. In 2026, trials are exploring dupilumab in patients with lower eosinophil counts and in combination with triple inhaler therapy.

Other Biologics in Trials

Itepekimab (anti-IL-33): Phase 3 trials in ex-smokers with COPD showed reduction in exacerbations. Former smokers may benefit more than current smokers due to different inflammatory profiles. Sanofi's AERIFY trials are recruiting.

Tezepelumab (anti-TSLP): Approved for severe asthma, now in Phase 3 for COPD (COURSE trial). TSLP is an epithelial cytokine involved in airway inflammation in both conditions.

Astegolimab (anti-IL-33): Roche's Phase 3 SKYLARK trial in COPD with eosinophilic inflammation is actively recruiting.

Novel Bronchodilators and Combination Inhalers

Ensifentrine (Ohtuvayre), a dual PDE3/PDE4 inhibitor inhaler, was approved in 2024 as the first new bronchodilator class in over 20 years. It provides both bronchodilation and anti-inflammatory effects. Post-marketing trials are comparing it to existing LABA/LAMA combinations and studying its role in triple therapy.

Lung Regeneration Research

Emphysema involves permanent destruction of alveolar tissue. Early-stage research is testing drugs that may promote alveolar regeneration — retinoic acid derivatives, growth factors, and stem cell approaches. These are largely Phase 1/2 and represent longer-term research directions rather than near-term options.

Eligibility for COPD Trials

Most COPD trials require: confirmed COPD diagnosis (post-bronchodilator FEV1/FVC <0.70), spirometry-confirmed severity (FEV1 % predicted), smoking history (≥10 pack-years), history of exacerbations in the past year, and current inhaler therapy. Biologic trials often require blood eosinophil counts — a simple blood test. Stable COPD is required at enrollment (no exacerbation within 4–6 weeks).

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