Forced Vital Capacity Ratio Research Articles

Systematic Review and Meta-analysis of Pirfenidone, Nintedanib, and Pamrevlumab for the Treatment of Idiopathic Pulmonary Fibrosis.

The comparative efficacy of pirfenidone, nintedanib, and pamrevlumab in slowing the rate of forced vital capacity (FVC) decline and mortality in patients with idiopathic pulmonary fibrosis (IPF) is unknown. To perform a systematic review and meta-analysis (MA) of these drugs for IPF. We searched CENTRAL, PubMed, EMBASE, ClincalTrials.gov, and the World Health Organization's registry databases up to March 2020. Phase II/III randomized controlled trials in adults with IPF were eligible. The random-effect model was implemented calculating the effect size and respective 95% CI as Cohen's d for change from baseline FVC (in percentage predicted and liters) and odds ratio (OR) for 10% reduction in FVC and all-cause mortality (ACM). Six studies were included in the MA. For change from baseline in percentage predicted FVC, the MA indicated that the 3 drugs were more effective than placebo (pirfenidone: d=3.30%, 95% CI=2.15-4.45; nintedanib: d=3.15%, 95% CI=2.35-3.95; pamrevlumab: d=4.30%, 95% CI=0.45-8.15). These results are superimposable to those relating to change from baseline FVC in liters (pirfenidone: d=0.09L, 95% CI=0.04-0.14; nintedanib: d=0.13L, 95% CI=0.10-0.16; pamrevlumab: d=0.20L, 95% CI=0.05-0.35). Each drug had a positive effect on 10% reduction in FVC (pirfenidone: OR=0.57, 95% CI=0.45-0.74; nintedanib: OR=0.66, 95% CI=0.51-0.85; pamrevlumab: OR=0.24, 95% CI=0.08-0.73), but only pirfenidone showed an effect on ACM (OR=0.50; 95% CI=0.31-0.83). This MA provided encouraging results on pamrevlumab efficacy in slowing the decline in FVC compared with pirfenidone and nintedanib. Actually, in phase 3, it could become a potential IPF treatment.

Association of Vitamin D Levels and Other Risk Factors with Asthma Exacerbations in Children

Background: The risk factors for asthma exacerbations are well understood. However, the effect of vitamin D levels on number of asthma exacerbations per year is not clearly studied. The objective of the study was to find out the association of serum vitamin D levels and asthma risk factors on asthma exacerbations. Methods: In this study, ninety-nine subjects from 5 to 15 years of age were recruited at an episode of acute exacerbation. It was a cross sectional study and carried out from 2012 to 2015. Pulmonary function test was done by spirometry. Asthma exacerbation was labeled when forced expiratory volume/ forced vital capacity (FEV1/FVC) ratio was less than 80% (American Thoracic Society). Global Initiative for Asthma (GINA) guidelines were used to classify asthma into mild, moderate and severe persistent asthma. Serum vitamin D levels were measured by chemiluminescence method. Pearson Chi-square test was applied and p value (p<0.05) was considered as statistically significant. Results: Children who had exposure to animal dander had significantly lower asthma exacerbations per year (p-value <0.046). There was no significant association between vitamin D levels and number of exacerbations per years (p-value <0.099). Asthma was prevalent in girls of low socioeconomic status (SES) compared to males. However, there was no significant association between smoke, exercise, home environment, food allergies, weather, pollen and dust with asthma exacerbations. Conclusion: Low levels of vitamin D were not associated with increased number of asthma exacerbations per year. However, children exposed to animal dander had lesser number of exacerbations per year (p-value <0.046). Keywords: Asthma; Vitamin D; Children; Exacerbations, Risk factors.

Short term effects of rapid maxillary expansion on breathing function assessed with spirometry: A case-control study

BackgroundThe aim of this work is to evaluate changes following rapid maxillary expansion (RME) on breathing function in two groups of patients: mouth breathers and nasal breathers. Materials and methodsTwenty-five oral breather patients (12 male, 13 female, mean age 15.2 ± 1.3), and 25 nasal breather patients (14 male, 11 female, mean age 15.3 ± 1.6) were treated with RME. Breathing function was evaluated by computerized spirometry. Forced vital capacity (FVC), forced expiratory volume in the first second (FEV1), Tiffenau index (FEV1/ FVC ratio, IT%), forced expiratory flow at 25–75% of vital capacity (FEF 25–75%), and Tidal volume (TV) were assessed. Breathing function analysis was performed before RME and 6 and 12 months after RME during follow-up appointments. The Shapiro–Wilk test was used to assess whether data were normally distributed. As data were not normally distributed, Mann–Whitney U and Friedman tests were used to perform comparisons between treatment groups and within group comparisons, respectively. ResultsOral breathers and nasal breathers showed statistically significant differences in FVC, FEF 25–75%, and TV at T0. They did not present any statistically significant difference in FEV1 and IT% at the same time point.Statistically significant differences were noticed for all indices in the oral breather group after maxillary expansion, while the nasal breather group showed statistically significant differences only in FCV, FEF 25–75%, and TV after treatment.There were no statistically significant differences in all indices 12 months after maxillary expansion between the oral breather and nasal breather groups. ConclusionsRME appeared to improve breathing function in both groups. Forced vital capacity (FVC), forced expiratory flow at 25–75% of vital capacity (FEF 25–75), and Tidal volume (TV) reached similar values in both groups after treatment with RME.

Inhaled therapy for chronic obstructive pulmonary disease

Chronic obstructive pulmonary disease is characterised by progressive symptoms of productive cough, breathlessness, wheeze and exacerbations. Airway obstruction is detected by quality assured spirometry, and is defined as a Forced Expired Volume in one second / Forced Vital Capacity ratio <0.7. Inhaled therapy is the most effective treatment solution, with bronchodilators and inhaled steroids helping to improve symptoms, quality of life and lung function, while reducing risk of exacerbations. Bronchodilators are available as both monotherapy and as dual combination therapy. Inhaled steroids can be added to inhaled long-acting bronchodilators, but are not without significant complications, including pneumonia. Therefore, careful assessment of the phenotype of a patient with chronic obstructive pulmonary disease must be given before commencing any therapy that contains inhaled steroid and other treatments, such as flu vaccination, smoking cessation and pulmonary rehabilitation should be given due consideration.

Enhancing the prediction of childhood asthma remission: Integrating clinical factors with microRNAs

Approximately 15% to 65% cases of childhood asthma undergo remission of disease by early adulthood.1,2 Predicting the remission of childhood asthma is important for providing clinical risk stratification and anticipatory guidance to patients and their families. Previously, in the Childhood Asthma Management Program (CAMP), we used clinical variables to predict the remission of childhood asthma by early adulthood with high accuracy (area under the receiver-operating characteristic curve [AUROC], 0.81) and found baseline FEV1 to forced vital capacity (FVC) ratio (FEV1/FVC) to be the greatest predictor of asthma remission.

Efficacy and safety of sildenafil added to pirfenidone in patients with advanced idiopathic pulmonary fibrosis and risk of pulmonary hypertension: a double-blind, randomised, placebo-controlled, phase 2b trial

The benefit of sildenafil in patients with advanced idiopathic pulmonary fibrosis (IPF) at risk of poor outcomes from pulmonary hypertension, whether already present or likely to develop, is uncertain. We aimed to assess the efficacy and safety of sildenafil added to pirfenidone versus placebo added to pirfenidone for 52 weeks in patients with advanced IPF and at risk of group 3 pulmonary hypertension. We did a multicentre, international, double-blind, randomised, placebo-controlled, phase 2b study at 56 university clinics, research hospitals, and tertiary sites in Canada, Europe (Belgium, Czech Republic, Germany, Greece, Hungary, Italy, the Netherlands, Spain, and Turkey), Israel, and Africa (Egypt and South Africa). Eligible patients (aged 40-80 years) had advanced IPF (carbon monoxide diffusing capacity ≤40% predicted at screening), and were at risk of group 3 pulmonary hypertension (mean pulmonary artery pressure of ≥20 mm Hg with pulmonary artery wedge pressure of ≤15 mm Hg on previous right-heart catheterisation, or intermediate or high probability of group 3 pulmonary hypertension on echocardiography as defined by the 2015 European Society of Cardiology and European Respiratory Society guidelines). Patients were randomly assigned 1:1 to oral sildenafil tablets (20 mg three times daily) or placebo, both in addition to oral pirfenidone capsules (801 mg three times daily), using a validated interactive voice-based or web-based response system with permuted block randomisation, stratified by previous right-heart catheterisation (yes or no) and forced expiratory volume in 1 s to forced vital capacity ratio (<0·8 or ≥0·8). The composite primary endpoint was disease progression, defined as either a relevant decline in 6-min walk distance, respiratory-related admission to hospital, or all-cause mortality, after 52 weeks and was assessed in the intention-to-treat population; safety was assessed in all patients who received at least one dose of the study drug. This trial is registered with ClinicalTrials.gov, NCT02951429, and is no longer recruiting. The 11-month safety follow-up is ongoing. Between Jan 13, 2017, and Aug 30, 2018, 247 patients were screened for eligibility, 177 of whom were randomly assigned to a treatment group (n=88 sildenafil; n=89 placebo) and were assessed for the primary outcome. There was no difference in the proportion of patients with disease progression over 52 weeks between the sildenafil (64 [73%] of 88 patients) and placebo groups (62 [70%] of 89 patients; between-group difference 3·06% [95% CI -11·30 to 17·97]; p=0·65). Serious treatment-emergent adverse events were reported in 54 (61%) patients in the sildenafil group and 55 (62%) patients in the placebo group. Treatment-emergent adverse events leading to mortality occurred in 22 (25%) patients in the sildenafil group and 26 (29%) in the placebo group. Addition of sildenafil to pirfenidone did not provide a treatment benefit versus pirfenidone plus placebo up to 52 weeks in patients with advanced IPF and risk of pulmonary hypertension. No new safety signals were identified with either treatment. Although the absence of a beneficial treatment effect suggests that sildenafil is not an appropriate treatment in the overall population, further research is required to establish if specific subgroups of patients with IPF might benefit from sildenafil. F Hoffmann-La Roche.

Inspiratory muscle training improves strength and health-related quality of life in hemodialysis patients

Background: Patients undergone hemodialysis (HD) suffer with energy-protein malnutrition, uremic myopathy and protein catabolism reducing their functional capacity, tolerance to exercise and aspects related to quality of life. Objective: The aim of this study was to evaluate the effects of the two protocols of inspiratory muscle training (IMT) on muscle strength, pulmonary function and related-health quality of life on male HD patients. Methods: Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP), peak expiratory flow (PEF), forced expiratory volume in first second (FEV1 ), forced vital capacity (FVC) and the FEV1 /FVC ratio and quality of life were evaluated pre and post six months of IMT in HD patients. IMT was performed by one group using a specific training (Power breathe) device (T-IMT, n=19) and by the other with incentive spirometry (I-IMT, n= 15). Results: Following the inspiratory training, muscle strength improved in both groups. The group that used incentive spirometry had increments in MIP larger (39.8%, p&lt;0.001) than the group that trained with the specific training device (28.3%, p=0.001). The KDQOL-SF dimensions showed significant difference in the T-IMT group in cognitive function (p=0.03), sexual function (p=0.009) and social function dimensions (p=0.04) and in the I-IMT group in the physical function dimension (p=0.03). Conclusion: It was proved that IMT improved muscle strength and I-IMT promoted increments significantly larger in MIP. Aspects of health-related quality of life of HD male patients improved significantly with T-IMT (sexual, social and cognitive functions), while I-IMT ameliorated only physical function.

Prediction of Spirometric Indices Using Forced Oscillometric Indices in Patients with Asthma, COPD, and Interstitial Lung Disease.

Background and ObjectiveSpirometry is sometimes difficult to perform in elderly patients and patients with cognitive impairment. Forced oscillometry (FOT) is a simple, noninvasive technique used for measuring respiratory impedance. The aim of this study was to develop regression equations to estimate vital capacity (VC), forced vital capacity (FVC), and forced expiratory volume in 1 s (FEV1.0) on the basis of FOT indices and to evaluate the accuracy of these equations in patients with asthma, chronic obstructive pulmonary disease (COPD), and interstitial lung disease (ILD).Materials and MethodsWe retrospectively included data on 683 consecutive patients with asthma (388), COPD (128), or ILD (167) in this study. We generated regression equations for VC, FVC, and FEV1.0 by multivariate linear regression analysis and used them to estimate the corresponding values. We determined whether the estimated data reflected spirometric indices.ResultsActual and estimated VC, FVC, and FEV1.0 values showed significant correlations (all r > 0.8 and P < 0.001) in all groups. Biases between the actual data and estimated data for VC, FVC, and FEV1.0 in the asthma group were −0.073 L, −0.069 L, and 0.017 L, respectively. The corresponding values were −0.064 L, 0.027 L, and 0.069 L, respectively, in the COPD group and −0.040 L, −0.071 L, and −0.002 L, respectively, in the ILD group. The estimated data in the present study did not completely correspond to the actual data. In addition, sensitivity for an FEV1.0/FVC ratio of <0.7 and the diagnostic accuracy for the classification of COPD grade using estimated data were low.ConclusionThese results suggest that our method is not highly accurate. Further studies are needed to generate more accurate regression equations for estimating spirometric indices based on FOT measurements.

Volumetric assessment of paranasal sinus opacification on computed tomography can be automated using a convolutional neural network.

Computed tomography (CT) plays a key role in evaluation of paranasal sinus inflammation, but improved, and standardized, objective assessment is needed. Computerized volumetric analysis has benefits over visual scoring, but typically relies on manual image segmentation, which is difficult and time-consuming, limiting practical applicability. We hypothesized that a convolutional neural network (CNN) algorithm could perform automatic, volumetric segmentation of the paranasal sinuses on CT, enabling efficient, objective measurement of sinus opacification. In this study we performed initial clinical testing of a CNN for fully automatic quantitation of paranasal sinus opacification in the diagnostic workup of patients with chronic upper and lower airway disease. Sinus CT scans were collected on 690 patients who underwent imaging as part of multidisciplinary clinical workup at a tertiary care respiratory hospital between April 2016 and November 2017. A CNN was trained to perform automatic segmentation using a subset of CTs (n = 180) that were segmented manually. A nonoverlapping set (n = 510) was used for testing. CNN opacification scores were compared with Lund-MacKay (LM) visual scores, pulmonary function test results, and other clinical variables using Spearman correlation and linear regression. CNN scores were correlated with LM scores (rho = 0.82, p < 0.001) and with forced expiratory volume in 1 second (FEV1 ) percent predicted (rho = -0.21, p < 0.001), FEV1 /forced vital capacity ratio (rho = -0.27, p < 0.001), immunoglobulin E (rho = 0.20, p < 0.001), eosinophil count (rho = 0.28, p < 0.001), and exhaled nitric oxide (rho = 0.40, p < 0.001). Segmentation of the paranasal sinuses on CT can be automated using a CNN, providing truly objective, volumetric quantitation of sinonasal inflammation.

Pattern of Pulmonary Dysfunctions in Craniovertebral Junction Anomaly and Its Persistence after Rigid Occipitocervical Fixation

Abstract Introduction Despite a significant advancement in operative techniques of occipitocervical fixation, there is a poor postoperative patient outcome. This can be attributed to restrictive lung pattern in craniovertebral junction anomalies (CVJAs) patients resulting from repeated trauma to cervicomedullary junction by the pincer action of the bony anomalies and compression of the brainstem. We evaluate the changes in pulmonary function tests (PFTs) following rigid occipitocervical fixation in CVJA. Methods PFTs of 20 CVJA patients were measured pre and postoperatively using spirometry. Measurements included forced vital capacity (FVC), forced expiratory volume in one second (FEV1), maximum forced mid-expiratory flow rate (FEF25–75%), and ratio of FEV1 and FVC (FEV1%). The parameters were compared with the predicted normal values based on their age and sex. PFTs were repeated on the seventh postoperative day. McCormick grading was used to assess neurological function. Results The values of PFTs in the preoperative period were significantly lower than predicted normal values. The mean values of FVC, FEV1, FEF25–75% were 72, 68, and 71% of their mean predicted values, with FEV1% in the range of 70 to 95% with a mean of 81.4%. Postoperatively there was further significant reduction in the mean values of FVC, FEV1, FEF25–75%, and FEV1% compared with the preoperative values. There was neurological improvement in McCormick grades of patients postoperatively (from grade III and IV to grade II). Conclusion A significant restrictive lung disease is present in patients of CVJA, even though not clinically apparent, and it persists in the early postoperative period. However, a long-term follow-up is required to assess whether pulmonary function parameters improve subsequently.

Respiratory Dysfunction and Sleep-Disordered Breathing in Children With Myasthenia Gravis.

The purpose of this study was to prospectively evaluate sleep patterns and the presence of sleep-disordered breathing in children with myasthenia gravis. We further aimed to examine the relationship between sleep and daytime respiratory function using spirometry tests including upright and supine forced vital capacity, sniff nasal inspiratory pressure, and maximal inspiratory pressure. Eleven children between 3 and 18 years old with confirmed myasthenia gravis were recruited from The Hospital for Sick Children Neuromuscular Clinic in this prospective observational study. After informed consent was obtained, patients underwent a comprehensive clinical assessment with collection of anthropometric data. Following this, all subjects performed pulmonary function tests, overnight polysomnography and completed the Epworth Sleepiness Scale questionnaire. Two of eleven children who reported no symptoms of sleep disordered breathing were diagnosed with mild to moderate obstructive sleep apnea. Pulmonary function tests showed abnormal maximal inspiratory pressure in 6 of 11 patients, whereas seated forced vital capacity as well as seated to supine forced vital capacity ratios were normal in the entire group. In our small group of pediatric myasthenia gravis subjects, there was an unexpected finding of obstructive sleep apnea in 2 of the 11 patients studied. Maximal inspiratory pressure appears to be a more sensitive method of detecting abnormalities compared to upright or seated forced vital capacity. A larger multicenter study is needed to validate our findings and to determine the impact of obstructive sleep apnea in the pediatric myasthenia gravis population as well as risk factors associated with sleep disordered breathing.

P0802RELATIONSHIP BETWEEN RENAL INSUFFICIENCY AND AIRFLOW LIMITATION AND THEIR IMPACT ON MORTALITY IN A COMMUNITY-BASED POPULATION: THE YAMAGATA (TAKAHATA) STUDY

Abstract Background and Aims Chronic kidney disease and chronic obstructive pulmonary disease (COPD) are known risk factors for mortality. In this study, we investigated the association between renal deficiency and airflow limitation that characterizes COPD, and its effect on 10-year mortality in a community-based population. Method The study subjects were 1,233 health check-up participants (mean age 64 years; 46.7% men). We defined renal insufficiency as GFR &amp;lt;60 mL/min/1.73m2 estimated using serum creatinine (Cr) or cystatin C (CysC), and airflow limitation (AFL) as forced expiratory volume in 1 second to forced vital capacity ratio &amp;lt;70% on spirometry. Results The prevalence of Cr-based and CysC-based renal insufficiency, and AFL in total subjects was 6.6%, 14.8%, and 11.2%, respectively. Compared with subjects without AFL, those with AFL showed a significantly higher prevalence of CysC-based renal insufficiency (24.6% vs. 13.5%, P &amp;lt;0.01), but not of Cr-based renal insufficiency (8.0% vs. 6.4%, P =0.77). The prevalence of CysC-based renal insufficiency was increased, along with the progression of AFL severity (P for trend &amp;lt;0.01). During the follow-up period, there were 154 (12.5%) deaths. Cox proportional hazard analysis adjusted for confounders showed that the hazard ratio (95% confidence interval) for all-cause mortality was 1.76 (1.12-2.71) in subjects with CysC-based renal insufficiency alone, 1.13 (0.62-1.94) in those with AFL alone, and 2.30 (1.20-4.18) in those with both CysC-based renal insufficiency and AFL, with subjects without both CysC-based renal insufficiency and AFL as the reference. In contrast, the adjusted hazard ratios for all-cause mortality did not reach statistical significance in subjects with both Cr-based renal insufficiency and AFL, with subjects without both Cr-based renal insufficiency and AFL as the reference. Conclusion This study showed that CysC-based renal insufficiency and AFL are strongly associated and that their overlap is a significant risk for mortality in community-based populations.

A Dyadic Growth Modeling Approach for Examining Associations Between Weight Gain and Lung Function Decline.

The relationship between body weight and lung function is complex. Using a dyadic multilevel linear modeling approach, treating body mass index (BMI; weight (kg)/height (m)2) and lung function as paired, within-person outcomes, we tested the hypothesis that persons with more rapid increase in BMI exhibit more rapid decline in lung function, as measured by forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and their ratio (FEV1:FVC). Models included random intercepts and slopes and adjusted for sociodemographic and smoking-related factors. A sample of 9,115 adults with paired measurements of BMI and lung function taken at ≥3 visits were selected from a pooled set of 5 US population-based cohort studies (1983-2018; mean age at baseline = 46 years; median follow-up, 19 years). At age 46 years, average annual rates of change in BMI, FEV1, FVC, and FEV1:FVC ratio were 0.22 kg/m2/year, -25.50 mL/year, -21.99 mL/year, and-0.24%/year, respectively. Persons with steeper BMI increases had faster declines in FEV1 (r=-0.16) and FVC (r=-0.26) and slower declines in FEV1:FVC ratio (r=0.11) (all Pvalues <0.0001). Results were similar in subgroup analyses. Residual correlations were negative (P<0.0001), suggesting additional interdependence between BMI and lung function. Results show that greater rates of weight gain are associated with greater rates of lung function loss.

Abstract 143: Improvement Of Pulmonary Function After Removal Of Breast Implant And Total Capsulectomy: An Objective Outcome Assessment In Breast Implant Illness

Purpose: Breast Implant Illness (BII) after aesthetic breast augmentation remains a poorly defined syndrome. Patients attribute a spectrum of symptoms to breast implants. Previously published series have observed a subjective improvement in breathing following breast implant removal and total capsulectomy. We hypothesized that patients presenting with BII would have significant improvement in pulmonary function tests after removal of their breast implants and capsules (explantation). Methods: A retrospective study of all patients presenting to a single-surgeon practice over 2 years who elected removal of breast implants and total capsulectomy due to a number of systemic complaints was conducted. Paired T-tests were used to compare PFTs before and after removal of breast implants and capsules. For patients with multiple post-op PFTs, highest post-op PFT scores were analyzed. Multivariate analyses and linear regression models were used examine the impact of patient- and implant-related factors on PFT changes. Results: Sixty-nine (69) patients met inclusion criteria. Forced vital capacity (FVC) (mean pre: 3.67 +/- 0.61 L vs. post: 3.82 +/- 0.55 L), forced expiratory volume (FEV1) (2.78 +/- 0.44 L vs 2.89 +/- 0.39 L) and peak expiratory flow rate (PEFR) (5.91 +/- 1.43 L vs 6.56 +/- 0.96 L) were significantly improved post-operatively (p=0.004, 0.01, 0.0001, respectively). Forced expiratory volume at 25-75% of pulmonary volume (FEV25-75) and FEV1:FVC ratio were not significantly different (p=0.35, 0.78). Implant surface had a statistically significant impact on PFT change pre- to post-surgery, with textured implants showing a greater improvement in PFTs after their removal (p=0.009). Conclusion: This study demonstrates that patients presenting with symptomatic implant BII had significant improvement in pulmonary function based on standard PFT evaluation after explantation. The results of our study indicate measurable restrictive effects of implants and their capsules on the chest wall particularly with textured implants. Further investigation is needed to elucidate the cellular mechanisms associated with the restrictive chest wall mechanics and inflammatory process associated with BII.

Efficacy and Safety of Once-Daily Inhaled Umeclidinium in Asian Patients with COPD: Results from a Randomized, Placebo-Controlled Study.

PurposePrevious studies demonstrating efficacy and safety of once-daily umeclidinium (UMEC) in patients with chronic obstructive pulmonary disease (COPD) have included few Asian patients. This study evaluated efficacy and safety of UMEC 62.5 mcg versus placebo in Asian patients with COPD.Patients and MethodsA Phase III, randomized, double-blind, parallel-group study. Patients (aged ≥40 years with COPD, pre-, and post-albuterol forced expiratory volume in 1 s [FEV1]/forced vital capacity ratio <0.70 and low risk of exacerbations) were randomized 2:1 to once-daily UMEC 62.5 mcg or placebo via the ELLIPTA inhaler for 24 weeks. Primary endpoint was change from baseline (CFB) in trough FEV1 on Day 169. Secondary endpoints were weighted mean FEV1 over 0–6 hrs post-dose on Day 1 and CFB in Transition Dyspnea Index (TDI) focal score on Day 168.ResultsA total of 306 patients were included in the modified intent-to-treat population (UMEC: 205; placebo: 101). UMEC versus placebo provided a statistically significant improvement in least squares (LS) mean trough FEV1 between baseline and Day 169 (154 mL [95% confidence interval (CI): 113, 194]; p<0.001). A clinically meaningful difference of 125 mL in favor of UMEC (95% CI: 103, 147; p<0.001) was also seen in LS weighted mean FEV1 0–6 hrs post-dose on Day 1. A LS mean treatment difference in TDI focal score of 0.9 units in favor of UMEC was seen on Day 168 (95% CI: 0.3, 1.5; p=0.004). Incidence of on-treatment adverse events (AEs) was lower in the placebo (55%) versus UMEC arm (60%); non-fatal serious AEs, drug-related AEs, and AEs leading to withdrawal were similar with UMEC and placebo.ConclusionOnce-daily UMEC 62.5 mcg resulted in statistically significant and clinically meaningful improvements in lung function and dyspnea, compared with placebo, in Asian patients with COPD, with no new safety concerns observed.

Association among chronic kidney disease, airflow limitation, and mortality in a community-based population: The Yamagata (Takahata) study

Chronic kidney disease (CKD) and chronic obstructive pulmonary disease (COPD) are known risk factors for mortality. In this study, we examined the overlap of CKD and airflow limitation (AFL) that characterises COPD and its effect on 10-year mortality in a community-based population. This study included 1,233 health check-up participants (mean age, 63.7 years; 46.7% men). We defined serum creatinine-based CKD (CKDcr) and serum cystatin C-based CKD (CKDcys) as glomerular filtration rate <60 mL/min/1.73 m2, estimated using serum creatinine or cystatin C, and/or dipstick proteinuria ≥1+. AFL was defined as forced expiratory volume in 1 s to forced vital capacity ratio <70% on spirometry. Compared with subjects without AFL, those with AFL showed a significantly higher prevalence of CKDcys but not of CKDcr. Cox proportional hazard analysis adjusted for confounders showed that the hazard ratio (95% confidence interval) for all-cause mortality was 1.45 (0.77–2.63) in subjects with CKDcys alone, 1.29 (0.60–2.54) in those with AFL alone, and 2.94 (1.33–6.12) in those with both CKDcys and AFL, with subjects without both AFL and CKD as the reference. This study showed that AFL and CKDcys are strongly associated and that their overlap is a significant risk factor for mortality in community-based populations.

Impact of long-term exposure wildfire smog on respiratory health outcomes

ABSTRACTBackground: Air pollution is a global problem and also linked to respiratory diseases. Wildfire smog is a major cause of air pollution in the upper northern area of Thailand. Thus, in the current study, we examined whether long-term exposure to wildfire smog induces lung function changes in a population from the upper northern area of Thailand.Methods: The lung function of 115 participants with long-term exposure smog was determined using peak flow meter.Results: Long-term smoke exposure participants decreased FEV1 (forced expiratory volume in 1 second)/FVC (forced vital capacity) ratio (56.49 ± 23.88 in males and 56.29 ± 28.23 in females) compared with general Thai population. Moreover, the reduction of FVC, FEV1, and peak expiratory flow rate (PEFR) values also showed in both male and female subjects. These results suggest that long-term smoke exposure induces obstructive lung abnormality. Moreover, itchy/watery nose, cough, phlegm, and chest pain also reported in these subjects.Conclusion: Wildfire smog could be induced respiratory pathway inflammation and easily collapsible respiratory airways.

Association of cathepsin B and cystatin C with an age-related pulmonary subclinical state in a healthy Chinese population.

Background:Cathepsin B (CTSB) and cystatin C (CYSC) are new biomarkers for several physiological and pathological processes as their activities increase with age. The aim of this study was to explore population-level associations between serum CTSB and CYSC with an age-related pulmonary subclinical state.Methods:We examined 401 healthy participants (aged 36–87 years, of which 44.3% were male) in northern Chinese cities. We used a standard spirometer to determine lung function. Serum CTSB and CYSC levels were measured by enzyme-linked immunosorbent assay (ELISA).Results:For all participants, serum CTSB was related to maximum vital capacity (VC MAX), forced vital capacity (FVC), forced expiratory volume in 1 s, peak expiratory flow, forced expiratory flow at 25% of FVC, forced expiratory volume in 3 s (FEV3), and inspiratory vital capacity (VC IN). These associations were lost after full adjustment. CYSC remained significantly associated with inspiratory capacity (IC), breath frequency (BF; p < 0.001), minute ventilation (MV), the ratio of FEV3 and FVC (FEV3%FVC), and expiratory reserve volume (p < 0.05) after adjusting for all other possible confounders. In males, serum CYSC levels exhibited significant and independent associations with FVC, FEV3 (p < 0.05), and IC (p < 0.001) and serum CTSB levels exhibited significant and independent associations with BF (p < 0.05).Conclusions:Our results confirmed serum CYSC concentration associations with an age-related lung function in healthy people. However, the association between serum CTSB and lung function was not well confirmed. Serum measurements of CYSC may provide valuable predictors of pulmonary function in healthy people, especially healthy elderly adults.The reviews of this paper are available via the supplemental material section.

Effect of Montelukast on Elderly Patients with Bronchial Asthma and Its Effect on Serum Transforming Growth Factor-beta1 and Cysteine Leukotriene Levels

To investigate the effect of montelukast on elderly patients with bronchial asthma and the effects of serum transforming growth factor β1 and cysteinyl leukotriene, 150 patients with bronchial asthma enrolled in the Central Hospital of Shanghai Jingan District between October 2016 to October 2018, and those who met the clinical diagnostic criteria were included. All patients were given antispasmodic and antiinfective treatment after admission. The study group (75 cases) were administered orally montelukast chewable tablets, while the control group (75 cases) was not given montelukast. Comparison of the efficacy of the two groups and lung function indicators before and after treatment, such as 1 second forced expiratory volume, first second forced expiratory volume versus forced vital capacity ratio (1 second forced expiratory volume/versus forced vital capacity), first second forced expiratory volume as predicted percentage and changes in the levels of serum transforming growth factor-β1 and cysteinyl leukotriene. The effective rate of treatment in the study group was higher than that in the control group (93.33 % vs 78.67 %, p<0.05). The first second forced expiratory volume, 1 second forced expiratory volume/versus forced vital capacity and percentage of first second forced expiratory volume/predicted of the study group were significantly increased after treatment (p<0.05), and higher than those of the control group (p<0.05). The levels of transforming growth factor-β1 and cysteinyl leukotriene in the study group were significantly decreased before treatment (p<0.05), and were lower than those in the control group (p<0.05). Montelukast treatment of bronchial asthma in the elderly can significantly improve lung function and improve clinical outcomes. Its mechanism of action may be related to the reduction of transforming growth factor β1 and cysteinyl leukotriene levels.

Association between thoracic musculoskeletal abnormalities and lung function in preterm infants.

In view of the difficulties and risks of performing lung function tests in infants and the hypothesis that children with abnormal pulmonary test may exhibit thoracic musculoskeletal alterations. This study aimed to determine the frequency of abnormal lung function and their relationship. This was a cross-sectional study with children from 6 to 12months of corrected age, born at a gestational age of <37weeks and with a birthweight ≤1500g, who were subjected to a lung function test and photogrammetry--an objective and non-invasive procedure. To verify the association between the thoracic musculoskeletal abnormalities and measure changes in lung function, univariate linear regression was used. The level of statistical significance was setted at P<0.05. Of the 38 infants, 12 (31.6%) exhibited abnormal lung function, including 9 (23.7%) with obstructive function and 3 (7.9%) with restrictive function. A significant association was noted between forced expiratory volume at 0.5second <-2 z score and the acromion/xiphoid process/acromion angle (β=4.935); forced vital capacity <-2 z score and the angle of the manubrium/left acromion/trapezium (β=0.033) and forced expiratory volume at 0.5second and forced vital capacity ratio <-2 z score and the inframammillary point/xiphoid process/inframammillary point angle (β=0.043). Preterm infants with very low birthweight presented a high frequency of abnormal lung function, particularly obstructive type and thoracic musculoskeletal abnormalities were associated with changes in lung function.