Rationale: Children with preschool wheezing or school-age asthma are reported to have airway microbial imbalances. Objectives: To identify clusters in children with asthma or wheezing using oropharyngeal microbiota profiles. Methods: Oropharyngeal swabs from the U-BIOPRED (Unbiased Biomarkers for the Prediction of Respiratory Disease Outcomes) pediatric asthma or wheezing cohort were characterized

RATIONALE COPD exacerbations are a major cause of morbidity and mortality and preventing them is a key treatment target. Long-term macrolide treatment is effective at reducing exacerbations but there is a paucity of evidence for other antibiotic classes. To assess whether 12-month use of doxycycline reduces exacerbation rate in people with COPD. METHODS People with moderate to very severe COPD and

This article will be available on July 26, 2023.

RATIONALE CF transmembrane conductance regulator (CFTR) dysfunction is associated with mucus accumulation and worsening COPD symptoms. This Phase 2b dose-finding study compared a CFTR potentiator, icenticaftor (QBW251), with placebo in patients with COPD and chronic bronchitis. METHODS COPD patients on triple therapy for at least three months were randomized to six treatment arms (icenticaftor 450

RATIONALE Emerging data demonstrate that the smallest conducting airways, terminal bronchioles are the early site of tissue destruction in COPD and are reduced up to 41% by the time someone is diagnosed with mild (GOLD 1) COPD. OBJECTIVES To develop a single-cell atlas that describes the structural, cellular and extracellular matrix alterations underlying terminal bronchiole loss in COPD. METHODS This

RATIONALE Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease for which novel therapies are needed. External controls (ECs) could enhance IPF trial efficiency, though the direct comparability of ECs to concurrent controls is unknown. OBJECTIVES To develop IPF ECs by fit for purpose data standards to historical randomized clinical trial (RCT), multicenter registry (Pulmonary Fibrosis Foundation

RATIONALE Chronic obstructive pulmonary disease (COPD) is a prevalent and burdensome condition in low- and middle-income countries (LMICs). Challenges to better care include more effective diagnosis, and access to affordable interventions. There are no previous reports describing therapeutic needs in LMIC populations with COPD identified through screening. OBJECTIVE To describe unmet therapeutic need

RATIONALE Kidney injury is common and associated with worse outcomes in patient with septic shock. Mitochondrial resuscitation with thiamine (vitamin B1) may attenuate septic kidney injury. OBJECTIVES To assess whether thiamine supplementation attenuates kidney injury in septic shock. METHODS The Thiamine for Renal Protection in Septic Shock (TRPSS) trial was a multicenter, randomized, placebo-controlled

RATIONALE Ensifentrine is a novel, selective, dual phosphodiesterase (PDE)3 and PDE4 inhibitor with bronchodilator and anti-inflammatory effects. Replicate Phase 3 trials of nebulized ensifentrine were conducted (ENHANCE-1 and ENHANCE-2) to assess these effects in patients with COPD. OBJECTIVES To evaluate the efficacy of ensifentrine compared to placebo on lung function, symptoms, quality of life

RATIONALE While studies have evaluated emphysema and fibrotic interstitial lung abnormality (ILA) individually, less is known about their combined progression. OBJECTIVES To define clinically meaningful progression of fibrotic ILA in smokers without interstitial lung disease and evaluate the effects of fibrosis and emphysema progression on mortality. METHODS Emphysema and pulmonary fibrosis were assessed

Chronic obstructive pulmonary disease (COPD) is a complex, heterogeneous, progressive inflammatory airway disease associated with significant impact on patients' lives, including morbidity and mortality, and significant health-care related costs. Current pharmacologic strategies, including first- and second-line therapies such as long-acting β2-agonists, long-acting muscarinic antagonists, inhaled

RATIONALE It is not certain the extent to which childhood smoking adds COPD risk independent of lifetime cigarette exposure. OBJECTIVES We examined the association between age started smoking cigarettes regularly, current smoking status, smoking history, and risk of COPD. METHODS Cross-sectional survey of U.S. adults ≥40y in the 2020 National Health Interview Survey. Respondents who were ever cigarette

RATIONALE Post-bronchodilator (BD) spirometry is used for diagnosis of chronic obstructive pulmonary disease (COPD). However, pre-BD reference values are used for spirometry interpretation. OBJECTIVES To compare the resulting prevalence rates of abnormal spirometry and study the consequences of using pre- or post-BD reference values generated within the Swedish CArdioPulmonary bioImage Study (SCAPIS)

RATIONALE The diagnosis of COPD is based on low ratio of the forced expiratory volume in one second to the forced vital capacity (FEV1/FVC) but its severity is classified using percentage predicted FEV1 (ppFEV1). OBJECTIVE To test a new severity classification scheme for COPD using FEV1/FVC, a more robust measure of airflow obstruction than ppFEV1. METHODS In COPDGene (n=10,132), the severity of airflow

RATIONALE The COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) tool was developed to identify patients with undiagnosed COPD with FEV1 <60% predicted or risk of exacerbation as treatment criteria. OBJECTIVES To test the ability of CAPTURE to identify patients requiring treatment because of symptoms or risk of exacerbation or hospitalization