COPD is an inflammatory lung disease, comprising several conditions, including chronic bronchitis and emphysema, and can be caused by genetics and irritants like smoke or pollution. The disease affects more than 30 million Americans and is the fourth leading cause of death worldwide.

Exacerbations, or flare-ups, can cause accelerated loss of lung function, a decrease in quality of life, and reduce a person’s physical function and activity. More than 50% of people with COPD experience at least one acute COPD exacerbation within four years of an initial COPD diagnosis. Increased respiratory rates and decreased lung volumes are early signs of an exacerbation.

This new study examines how digital inhalers using remote monitoring data can help predict and identify early or impending COPD exacerbations. The digital inhaler used in this study measured peak inspiratory flow, inhalation volume, inhalation duration, time to peak inhalation, and inhaler use. The study examined whether the data collected by the digital inhaler could identify a possible early-stage exacerbation.

“While this study examined a small group of participants, the remote monitoring data showed people experienced significant decreases in the amount of air they inhaled and how long that inhalation lasted in the approximately two weeks prior to experiencing an exacerbation,” said M. Bradley Drummond, M.D., MHS, professor of medicine in the Division of Pulmonary Diseases and Critical Care Medicine at the University of North Carolina, Chapel Hill School of Medicine and lead author of the study. “As these remote monitoring technologies get more advanced, we can help both patients and health care providers identify exacerbations earlier, which allows us to provide better exacerbation management and improve health outcomes.”

To access current and past issues of Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation, visit journal.copdfoundation.org.

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“This is a really important advance for children with moderate-to-severe asthma and their families,” said lead investigator Leonard Bacharier, M.D., Professor of Pediatrics, Allergy/Immunology/Pulmonary Medicine at Vanderbilt University Medical Center in Nashville, Tennessee. “This is the first study of its kind in children ages 6 to 11 that has demonstrated that a biologic improves asthma exacerbations, lung function and asthma control. We were not surprised, because dupilumab was very effective in clinical trials in adults and adolescents, but we were delighted with the results and the hope they bring to children and their families,” Bacharier added.

The researchers conducted a 52-week phase 3, randomized, double-blind, placebo-controlled trial. They enrolled 408 subjects between the ages of 6 and 11 years, all diagnosed with uncontrolled moderate-to-severe asthma.

The subjects received a subcutaneous injection of dupilumab (n=273) 100 mg for those weighing ≤30 kg and 200 mg for those weighing >30 kg, or matched placebo (n=135) every 2 weeks. All subjects continued to receive a stable dose of standard background treatment.

The primary end point was the annualized rate of severe asthma exacerbations.

Secondary end points included the change in the percentage of predicted prebronchodilator forced expiratory volume in 1 second (ppFEV₁) at week 12, and the score on the Asthma Control Questionnaire 7 Interviewer-Administered (ACQ-7-IA) at week 24.

In subjects with the type 2 inflammatory phenotype, the annualized rate of severe asthma exacerbations was 0.31with dupilumab and 0.75 with placebo (P<0.001), a statistically significant difference.

The mean change from baseline in the ppFEV₁ was 10.5% with dupilumab and 5.3% with placebo, a statistically significant mean difference of 5.2% (P<0.001).

Dupilumab subjects also achieved significantly better asthma control than placebo subjects (P<0.001).

The authors concluded, “Among the children between the ages of 6 and 11 years in our trial who had uncontrolled moderate-to-severe asthma, those who added dupilumab to their standard therapy had a significantly lower rate of severe asthma exacerbations and had better lung function and asthma control than those who received placebo. Few randomized trials of add-on biologic therapy have been conducted in this age group, and we found that add-on dupilumab provided a clinically meaningful effect on lung function.”

In October, 2021, dupilumab was approved in in the United States for treatment of uncontrolled moderate-to-severe asthma among children between the ages of 6 and 11.

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