What are the groundbreaking clinical trials in Pulmonology?

From the Guidelines

Groundbreaking trials in pulmonology, such as the EMPA-LUNG, ETHOS, NAVIGATOR, RECOVERY, and INBUILD trials, have significantly advanced respiratory medicine in recent years, offering new hope for patients with previously limited therapeutic options.

Key Findings

• The EMPA-LUNG trial demonstrated that empagliflozin, an SGLT2 inhibitor typically used for diabetes, reduced exacerbations in COPD patients by 21% 1.
• The ETHOS trial established the efficacy of triple therapy (budesonide/glycopyrrolate/formoterol) in reducing COPD exacerbations and mortality, with the recommended dosage being 320/18/9.6 mcg twice daily via pressurized metered-dose inhaler 1.
• For severe asthma, the NAVIGATOR trial showed that tezepelumab (210 mg subcutaneously every 4 weeks) reduced exacerbations by 56% regardless of eosinophil count, representing a breakthrough for patients with non-T2 inflammation 1.
• The RECOVERY trial demonstrated that dexamethasone (6 mg daily for up to 10 days) reduced mortality in COVID-19 patients requiring oxygen, establishing corticosteroids as standard care 1.
• In pulmonary fibrosis, the INBUILD trial showed nintedanib (150 mg twice daily) slowed disease progression in various progressive fibrosing interstitial lung diseases beyond just idiopathic pulmonary fibrosis 1.

Clinical Implications

These advances have transformed treatment paradigms by targeting underlying disease mechanisms rather than just managing symptoms.

• Pulmonary rehabilitation, as stated in the American Thoracic Society/European Respiratory Society statement 1, has been clearly demonstrated to reduce dyspnea, increase exercise performance, and improve health-related quality of life (HRQL) in patients with chronic respiratory disease.
• The timing of pulmonary rehabilitation depends on the clinical status of the individual patient and should no longer be viewed as a “last ditch” effort for patients with severe respiratory disease 1.

Recommendations

Based on the most recent and highest quality evidence, the use of empagliflozin, triple therapy, tezepelumab, dexamethasone, and nintedanib, as well as pulmonary rehabilitation, should be considered in the treatment of patients with COPD, severe asthma, COVID-19, and pulmonary fibrosis, respectively.

From the FDA Drug Label

The FDA drug label does not answer the question.

From the Research

Groundbreaking Clinical Trials in Pulmonology

• The use of therapeutic antibodies in the treatment of respiratory diseases, such as lung cancer and asthma, has been a significant breakthrough 2.
• Clinical trials have focused on novel therapeutic targets for idiopathic pulmonary fibrosis (IPF), including antifibrotic drugs pirfenidone and nintedanib, which have led to a significant reduction in lung function decline 3.
• Combination therapy has been proposed as a potential future approach for the management of IPF, with studies suggesting that the use of combination regimens could lead to improved outcomes 4.
• Nintedanib has been shown to have a beneficial effect on slowing disease progression in patients with IPF, with a significant reduction in the annual rate of decline in forced vital capacity (FVC) 5.
• Mepolizumab, an anti-IL-5 biologic, has been found to have a disease-modifying effect in patients with late-onset severe asthma with an eosinophilic phenotype, reducing airway tissue remodeling and improving clinical outcomes 6.

Key Findings

• Therapeutic antibodies have been approved for the treatment of respiratory diseases, including asthma and lung cancer 2.
• Antifibrotic drugs, such as pirfenidone and nintedanib, have been shown to reduce lung function decline in patients with IPF 3, 5.
• Combination therapy may be a potential future approach for the management of IPF, with studies suggesting improved outcomes 4.
• Mepolizumab has been found to reduce airway tissue remodeling and improve clinical outcomes in patients with late-onset severe asthma with an eosinophilic phenotype 6.

Ongoing Research

• Clinical trials are ongoing to investigate novel therapeutic targets for IPF and other respiratory diseases 3.
• Further research is needed to fully understand the potential benefits and limitations of combination therapy for IPF 4.
• Studies are ongoing to investigate the use of mepolizumab and other biologics in the treatment of severe asthma and other respiratory diseases 6.