TUESDAY, Sept. 6, 2022 (HealthDay News) -- For symptomatic, tobacco-exposed persons with preserved lung function, inhaled dual bronchodilator therapy does not reduce respiratory symptoms, according to a study published online Sept. 4 in the New England Journal of Medicine to coincide with the European Respiratory Society International Congress 2022, held from Sept. 4 to 6 in Barcelona, Spain.
MeiLan K. Han, M.D., from the University of Michigan in Ann Arbor, and colleagues randomly assigned 535 persons with a tobacco-smoking history of at least 10 pack-years, respiratory symptoms, and preserved lung function on spirometry to receive indacaterol plus glycopyrrolate or placebo twice daily for 12 weeks.
The researchers found that in the modified intention-to-treat population (471 participants), 56.4 and 59.0 percent of those in the treatment (227 patients) and placebo (244 patients) groups, respectively, had a 4-point decrease (improvement) in the St. George's Respiratory Questionnaire score. The mean change in the percent of predicted forced expiratory volume in one second was 2.48 and −0.09 percentage points in the treatment and placebo groups, respectively, and the mean change in the inspiratory capacity was 0.12 and 0.02 liters, respectively. There were four serious adverse events reported in the treatment group and 11 in the placebo group; none were potentially related to treatment or placebo.
"Our data suggest that long-acting bronchodilators do not result in abatement of respiratory symptoms in these patients," the authors write. "Further research is urgently needed to better understand and treat the respiratory disease in these persons."
Novartis Pharmaceuticals donated the trial medication and placebo.