Bronchodilators in Tobacco-Exposed Persons with Symptoms and Preserved Lung Function.

BACKGROUND: Many persons with a history of smoking tobacco have clinically significant respiratory symptoms despite an absence of airflow obstruction as assessed by spirometry. They are often treated with medications for chronic obstructive pulmonary disease (COPD), but supporting evidence for this treatment is lacking. METHODS: We randomly assigned persons who had a tobacco-smoking history of at least 10 pack-years, respiratory symptoms as defined by a COPD Assessment Test score of at least 10 (scores range from 0 to 40, with higher scores indicating worse symptoms), and preserved lung function on spirometry (ratio of forced expiratory volume in 1 second [FEV1] to forced vital capacity [FVC] ≥0.70 and FVC ≥70% of the predicted value after bronchodilator use) to receive either indacaterol (27.5 µg) plus glycopyrrolate (15.6 µg) or placebo twice daily for 12 weeks. The primary outcome was at least a 4-point decrease (i.e., improvement) in the St. George's Respiratory Questionnaire (SGRQ) score (scores range from 0 to 100, with higher scores indicating worse health status) after 12 weeks without treatment failure (defined as an increase in lower respiratory symptoms treated with a long-acting inhaled bronchodilator, glucocorticoid, or antibiotic agent). RESULTS: A total of 535 participants underwent randomization. In the modified intention-to-treat population (471 participants), 128 of 227 participants (56.4%) in the treatment group and 144 of 244 (59.0%) in the placebo group had at least a 4-point decrease in the SGRQ score (difference, -2.6 percentage points; 95% confidence interval [CI], -11.6 to 6.3; adjusted odds ratio, 0.91; 95% CI, 0.60 to 1.37; P = 0.65). The mean change in the percent of predicted FEV1 was 2.48 percentage points (95% CI, 1.49 to 3.47) in the treatment group and -0.09 percentage points (95% CI, -1.06 to 0.89) in the placebo group, and the mean change in the inspiratory capacity was 0.12 liters (95% CI, 0.07 to 0.18) in the treatment group and 0.02 liters (95% CI, -0.03 to 0.08) in the placebo group. Four serious adverse events occurred in the treatment group, and 11 occurred in the placebo group; none were deemed potentially related to the treatment or placebo. CONCLUSIONS: Inhaled dual bronchodilator therapy did not decrease respiratory symptoms in symptomatic, tobacco-exposed persons with preserved lung function as assessed by spirometry. (Funded by the National Heart, Lung, and Blood Institute and others; RETHINC ClinicalTrials.gov number, NCT02867761.).

Prone Positioning of Patients With Coronavirus Disease 2019 Who Are Nonintubated in Hypoxic Respiratory Distress: Single-Site Retrospective Health Records Review.

INTRODUCTION: In March and April 2020 of the coronavirus disease 2019 pandemic, site clinical practice guidelines were implemented for prone positioning of patients with suspected coronavirus disease 2019 in hypoxic respiratory distress who are awake, alert, and spontaneously breathing. The purpose of this pandemic disaster practice improvement project was to measure changes in pulse oximetry associated with prone positioning of patients with coronavirus disease 2019 infection in adult acute respiratory distress or adult respiratory distress syndrome, who are awake, alert, spontaneously breathing, and nonintubated. METHODS: A retrospective chart review of patients who were coronavirus disease 2019 positive in the emergency department from March 30, 2020 to April 30, 2020 was conducted for patients with a room air pulse oximetry <90% and a preprone position pulse oximetry ≤94% who tolerated prone positioning for at least 30 minutes. The primary outcome was the change in pulse oximetry associated with prone positioning, measured on room air, with supplemental oxygen, and approximately 30 minutes after initiating prone positioning. Median and mean differences were compared with the Wilcoxon signed-rank test and paired t-test. RESULTS: Of the 440 patients with coronavirus disease 2019, 31 met inclusion criteria. Median pulse oximetry increased as 83% (interquartile range, 75%-86%) on room air, 90% (interquartile range, 89%-93%) with supplemental oxygen, and 96% (interquartile range, 94%-98%) with prone positioning (z = -4.48, P < .001). A total of 45% (n = 14) were intubated during their hospital stay, and 26% (n = 8) of the included patients died. DISCUSSION: In patients with coronavirus disease 2019 who are awake, alert, and spontaneously breathing, an initially low pulse oximetry reading improved with prone positioning. Future studies are needed to determine the association of prone positioning with subsequent endotracheal intubation and mortality.