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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. opens in new tab.) [ABSTRACT FROM AUTHOR]

Study Objectives: To examine the association of self-identified race with sleep quality in heavy smokers., Methods: We studied baseline data from 1965 non-Hispanic White and 462 African American participants from SPIROMICS with ≥ 20 pack-years smoking history. We first examined the Pittsburgh Sleep Quality Index's (PSQI) internal consistency and item-total correlation in a population with chronic obstructive pulmonary disease. We then used staged multivariable regression to investigate the association of race and sleep quality as measured by the PSQI) The first model included demographics, the second added measures of health status, and the third, indicators of socioeconomic status. We next explored the correlation between sleep quality with 6-minute walk distance and St. George's Respiratory Questionnaire score as chronic obstructive pulmonary disease-relevant outcomes. We tested for interactions between self-identified race and the most important determinants of sleep quality in our conceptual model., Results: We found that the PSQI had good internal consistency and item-total correlation in our study population of heavy smokers with and without chronic obstructive pulmonary disease. African American race was associated with increased PSQI in univariable analysis and after adjustment for demographics, health status, and socioenvironmental exposures ( P = .02; 0.44 95%CI: .06 to .83). Increased PSQI was associated with higher postbronchodilator forced expiratory volume in 1 second and lower household income, higher depressive symptoms, and female sex. We identified an interaction wherein depressive symptoms had a greater impact on PSQI score for non-Hispanic White than African American participants ( P for interaction = .01)., Conclusions: In heavy smokers, self-reported African American race is independently associated with worse sleep quality., Clinical Trial Registration: Registry: ClinicalTrials.gov; Name: Study of COPD Subgroups and Biomarkers (SPIROMICS); URL: https://clinicaltrials.gov/ct2/show/NCT01969344; Identifier: NCT01969344., Citation: Baugh AD, Acho M, Arhin A, et al. African American race is associated with worse sleep quality in heavy smokers. J Clin Sleep Med . 2023;19(8):1523-1532., (© 2023 American Academy of Sleep Medicine.)

Introduction: Antiplatelet therapy has been associated with fewer exacerbations and reduced respiratory symptoms in chronic obstructive pulmonary disease (COPD). Whether platelet activation is associated with respiratory symptoms in COPD is unknown., Methods: Former smokers with spirometry-confirmed COPD had urine 11-dehydro-thromboxane B2 (11dTxB2), plasma soluble CD40L (sCD40L), and soluble P-selectin (sP-selectin) repeatedly measured during a 6- to 9-month study period. Multivariate mixed-effects models adjusted for demographics, clinical characteristics, and medication use evaluated the association of each biomarker with respiratory symptoms, health status, and quality of life., Results: Among 169 participants (average age 66.5±8.2 years, 51.5% female, 47.5±31 pack years, forced expiratory volume in 1 second percent predicted 53.8±17.1), a 100% increase in 11dTxB2 was associated with worse respiratory symptoms reflected by higher scores on the COPD Assessment Test (β 0.77, 95% confidence interval [CI]: 0.11-1.4) and Ease of Cough and Sputum Clearance Questionnaire β 0.77, 95%CI: 0.38-1.2, worse health status (Clinical COPD Questionnaire β 0.13, 95%CI: 0.03-0.23) and worse quality of life (St George's Respiratory Questionnaire β 1.9, 95%CI: 0.39-3.4). No statistically significant associations were observed for sCD40L or sP-selectin. There was no consistent statistically significant effect modification of the relationship between urine 11dTxB2 and respiratory outcomes by history of cardiovascular disease, subclinical coronary artery disease, antiplatelet therapy, or COPD severity., Conclusions: In stable moderate-severe COPD, elevated urinary11dTxB2, a metabolite of the platelet activation product thromboxane A2, was associated with worse respiratory symptoms, health status, and quality of life., (JCOPDF © 2023.)