Impairment of small airways in COPD patients with frequent exacerbations and effects of treatment with tiotropium

Disease exacerbations are an important aspect of COPD, because they affect its course and are associated with higher lung function decline. On the other hand, data obtained by biopsies have demonstrated that the progression of COPD is related to an increasing impairment of small airways. We sought to evaluate the small airway impairment (FEF25–75) in two groups of COPD patients (each group had 37 subjects) in relation to the frequency of exacerbations and the effectiveness of treatment with tiotropium bromide on the small airway impairment. The mean number of exacerbations was 3.6/year and 1.38/year in frequent and in infrequent exacerbators, respectively (p < 0.001). The mean value of FEF25–75 at baseline was 624 mL and 865 mL in frequent and in infrequent exacerbators respectively (p = 0.002). The changes in respiratory parameters versus baseline showed increases in mean FEV₁, FVC, and FEF25–75 in both groups but only the increase in FEF25–75 in frequent exacerbators was statistically significantly (p = 0.013). During the 3-month period of the study the mean number of exacerbations was 0.66 in frequent and 0.12 in infrequent exacerbators. These findings indicate that COPD patients with frequent exacerbations have a higher impairment of small airways. Treatment with tiotropium in COPD subjects with frequent exacerbations proved to be effective in improving small airway impairment.     

Association of serum vitamin D levels with disease severity,systemic inflammation,prior lung function loss and exacerbations in a cohort of patients with chronic obstructive pulmonary disease (COPD)

BackgroundVitamin D deficiency has been associated with chronic disorders including chronic obstructive pulmonary disease (COPD) but the relationships with inflammation, exacerbations and disease progression remain unclear.MethodsIn this monocentric cross-sectional observational study we analyzed the disease status, systemic inflammation, prior exacerbation frequency and loss in lung function in relation to serum 25-hydroxyvitamin D (25-OHD) levels in a cohort of 94 patients with COPD. Serum 25-OHD, C-reactive protein, interleukin-6 and tumor necrosis factor-α were quantified. Exacerbation frequencies and sunlight exposure were assessed. These parameters were analyzed in correlation to the current forced expiratory volume in 1 s (FEV₁), the individual average 3-year FEV₁ decline and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage.ResultsWe observed fair correlation between serum 25-OHD and the current FEV₁ (r=0.38, P<0.001). Furthermore, mean serum 25-OHD was significantly altered between patients of GOLD stages I–IV (P=0.013). There was weak negative correlation of 25-OHD and the average annual change of the FEV₁ (r=−0.26, P<0.05). Furthermore, we observed fair negative correlation between 25-OHD and C-reactive protein (r=−0.32, P<0.01) as well as weak negative correlation with interleukin-6 (r=−0.23, P<0.05). While the exacerbation frequency significantly differed between GOLD stages (P=0.04), there was no direct association between exacerbations and 25-OHD levels.ConclusionOur data confirm frequent vitamin D deficiency in COPD and point out correlations between 25-OHD levels, systemic inflammation, disease severity and progression.     

Effect of thyroid function on COPD exacerbation frequency: a preliminary study

Background

Frequent exacerbations of chronic obstructive pulmonary disease (COPD) have negative effects on quality of life and survival. Thus, factors related to exacerbations should be determined. We aimed to evaluate the effects of thyroid function on quality of life and exacerbation frequency in COPD patients.

Methods

The study population (n?=?128) was divided into 3 groups (Group 1: COPD patients with hypothyroidism (n?=?44); Group 2: COPD patients with normal thyroid function tests (n?=?44); Group 3: Healthy subjects (n?=?40)). Pulmonary function tests, maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) measurements were performed. Quality of life questionnaire (Short Form 36, SF-36) was carried out. Patients were followed up for one year and number of exacerbations was recorded.

Results

FVC, FEV₁/FVC, and FEF _25–75% measurements were statistically different between group 1 and 2 (p?=?0.041, p?=?0.001, p?=?0.009 respectively). Although MEP values were significantly different between group 1 and 2 (p?=?0.006), there was no significant difference in MIP values between groups (p?=?0.77). Quality of life scores in group 1 and 2 were significantly lower than control group. Exacerbation frequency was significantly higher in group 1 than in group 2 (p?=?0.017). TSH values and exacerbation frequency had positive correlation (p?<?0.0001; r?=?0.82).

Conclusions

The results of the present study suggest that thyroid function has an effect in exacerbation frequency of COPD. Decrease in exacerbation numbers with early detection of impairment in thyroid function will have positive contribution on quality of life in COPD patients.

     

The paradoxical response to short-acting bronchodilator administration in patients with chronic obstructive pulmonary disease

BackgroundThere are a few studies about paradoxical bronchodilator response (BDR), which means a decrease in forced expiratory volume in 1 second (FEV₁) or forced vital capacity (FVC) after short-acting bronchodilator administration in patients with chronic obstructive pulmonary disease (COPD). We evaluated the effect of paradoxical BDR on the clinical outcomes of COPD patients in South Korea.MethodsWe analyzed the KOrea COpd Subgroup Study team (KOCOSS) cohort data in South Korea between January 2012 and December 2017. BDR was defined as at least a 12% and 200-mL reduction in FEV₁ or FVC after bronchodilator administration.ResultsA total of 1,991 patients were included in this study. A paradoxical BDR was noted in 57 (2.9%) patients and was independently associated with worse dyspnea and poor quality of life. High C-reactive protein (CRP) levels were associated with a paradoxical BDR (OR, 1.05; 95% CI, 1.01–1.09; P=0.003). However, paradoxical BDR was not associated with severe acute exacerbations. Pre-bronchodilator FEV₁ (L) showed a higher area under the curve (AUC) for predicting severe acute exacerbations than the post-bronchodilator FEV₁ (L) in the paradoxical BDR group (0.788 vs. 0.752).ConclusionA paradoxical reduction of FEV₁ or FVC after bronchodilator administration may be associated with chronic inflammation in the airway and independently associated with worse respiratory symptoms and poor quality of life.     

What Predicts Change in Pulmonary Function and Quality of Life in Asthma or COPD?

Information about predictors of decline in pulmonary function (forced expiratory volume in 1 second [FEV₁]) or health-related quality of life (HRQoL) in patients with asthma or (chronic obstructive pulmonary disease [COPD]) might help to determine those who need additional care. A 2-year prospective cohort study was conducted among 380 asthma and 120 COPD patients. In both asthma and COPD patients, a 2-year change in FEV₁ was only weakly associated with a 2-year change in HRQoL (r =. 0.19 and 0.24, respectively). In both groups, older age, living in an urban environment, and a lower peak expiratory flow rate (PEFR) at baseline were associated with a decline in FEV₁. Additional predictors of FEV₁ decline were greater body weight, less chronic cough or sputum production, and less respiratory symptoms in asthma patients and current smoking in COPD patients. A decline in HRQoL was associated with older age, non-compliance with medication, more dyspnea, and a lower PEFR in asthma patients and with male gender, lower education, lower body weight, more dyspnea, and more respiratory symptoms in COPD patients. Our results show that FEV₁ and HRQoL appear to represent different disease aspects influenced by different predictors.     

Different COPD Disease Characteristics are Related to Different Outcomes in the 6-minute Walk Test

Abstract

Background: Chronic obstructive pulmonary disease (COPD) can lead to severe disability as the disease advances. The 6-minute walk test (6MWT) is commonly used to measure functional capacity in COPD patients and has three potential outcomes; walking distance, oxygen desaturation, and self-perceived dyspnea assessed by the Borg scale, all reflecting different aspects of COPD. The aim of this study was to identify predictors of all 3 outcomes of 6MWT in patients with COPD. Methods: 370 COPD patients, aged 40–75 yrs, were included from the first phase of the Bergen COPD cohort study. They were examined with spirometry, bioelectrical impedance measurements, 6MWT, Center for Epidemiologic Studies of Depression (CES-D) Scale, Medical Research Council (MRC) dyspnea scale, Charlson index for co-morbidities, self-reported physical activity questionnaire, plasma levels of C-reactive protein (CRP) and arterial blood gases. Results: Significant predictors in the multivariate analyses were sex, age, FEV₁ in% predicted, symptoms of dyspnea (MRC), co-morbidities (Charlson Index) and self-reported physical activity for walking distance, FEV₁ in% predicted and PaO₂ for oxygen desaturation, and body composition, smoking and co-morbidities for self-perceived dyspnea assessed by the Borg scale. Conclusion: Several COPD characteristics have predictive value for the 6MWT, and some COPD characteristics are more strongly related to specific 6MWT outcomes than others.     

慢性阻塞性肺疾病患者呼吸困难的定量评价及M胆碱受体拮抗剂 …

目的 探寻定量评价慢性阻塞性肺疾病（ＣＯＰＤ）患者呼吸困难的方法,并观察吸入Ｍ胆碱受体拮抗剂溴化异丙托品对其呼吸困难和运动能力的影响。方法 对２７例ＣＯＰＤ患者进行运动负荷试验同时测定每分钟氧摄取量（Ｖｏ２）。将运动中的勃氏分级（ＢＳ）指数与Ｖｏ２求取相关性。运动后,吸入溴化异丙托品,做肺功能检查。结果 （１）ＣＯＰＤ患者运动中的ＢＳ指数与Ｖｏ２呈直线相关,依据其回归直线,得到了三个定量评价呼吸困     

Effect of Indacaterol on Dynamic Lung Hyperinflation and Breathlessness in Hyperinflated Patients with COPD

Abstract: Indacaterol is a novel, inhaled once-daily ultra long-acting β₂-agonist for the treatment of COPD. This randomised, double-blind, placebo-controlled, two-period crossover study evaluated the effect of two-week treatment with indacaterol 300 μg on peak and isotime exercise inspiratory capacity (IC) in patients with COPD. Patients (40–80 years) with post-bronchodilator forced expiratory volume in 1 s (FEV₁)/forced vital capacity (FVC) <70%, percent predicted FEV₁ ≥40% and ≤80%, smoking history ≥20 pack-years and functional residual capacity >120% of predicted normal were randomised to receive indacaterol 300 μg or placebo once-daily via a single-dose dry powder inhaler. Following 14 days of treatment, IC at peak and isotime during constant-load (80% of maximum workload) cycle ergometry was analysed using linear mixed-effects models. Safety and tolerability were also monitored. Twenty-seven patients (67% male; mean age, 61.3 years) were randomised; 24 completed the study. On Day 14, indacaterol showed statistically significant improvements over placebo in peak (317 mL [95% CI: 118–517]; p < 0.01) and isotime IC (268 mL [95% CI: 104–432]; p < 0.01). Statistically significant improvements were observed with indacaterol versus placebo on Day 14 for the following secondary endpoints: resting IC, trough FEV₁, dyspnoea (BDI/TDI and Borg CR10 scale at isotime) and exercise endurance time. Indacaterol was well tolerated, with no serious adverse events or deaths. In conclusion, indacaterol 300 μg administered once-daily showed a clinically relevant increase in IC after 14 days of treatment, reflecting a reduction in dynamic hyperinflation.     

Factors Discriminating Spontaneous Pursed-Lips Breathing Use in Patients with COPD

ABSTRACT

Pursed-lips breathing (PLB) is often spontaneously performed by chronic obstructive pulmonary disease (COPD) patients. The aim of this study was to evaluate spontaneous PLB prevalence and to identify factors discriminating its use. Fifty-seven patients with COPD (FEV₁ = 44.3 ± 17.4%pred) underwent pulmonary function testing and two incremental bicycle exercise tests. Peak workload (Wpeak), oxygen uptake (VO₂peak), breathing pattern, and dyspnea (Borg scale) were measured in the first exercise test and spontaneous PLB performance in the second. Six patients spontaneously performed pursed-lips breathing during rest (PLBrest), exercise and recovery, 18 during exercise and recovery (PLBex), 7 during recovery only (PLBrec), 20 not at all (PLBno), and 6 performed other expiratory resistive maneuvers. PLBrest and PLBex patients exhibited a lower Wpeak, O₂ uptake, and minute ventilation (V_E), greater expiratory flow limitation and higher slopes relating dyspnea to V_E or W (%predicted). PLBrest patients were more hypercapnic, had a lower exercise tolerance and diffusion capacity, and greater flow limitation and hyperinflation. PLBrec and PLBno patients were indistinguishable with regard to pulmonary function, dyspnea, and exercise performance. The most significant independent predictors of spontaneous PLB use during exercise were FEV₁/FVC and the slope relating dyspnea to V_E. Spontaneous PLB is most often performed by COPD subjects when ventilation is stimulated by exercise, and during recovery from exercise. Severity of airflow obstruction and the dyspnea experienced during exercise play an important role in determining whether or not PLB is spontaneously performed by COPD patients.     

Tidal Expiratory Flow Limitation at Rest as a Functional Marker of Pulmonary Emphysema in Moderate-to-Severe COPD

Background: Tidal expiratory flow limitation (EFL) is a step of paramount importance in the functional decline in COPD. Among mechanisms contributing to EFL, loss of airway-parenchymal interdependence could mostly be involved. Aim: To assess if EFL is a functional marker more frequently linked to prevalent pulmonary emphysema rather than to prevalent chronic bronchiolitis in COPD patients with moderate-to-severe airflow obstruction. Methods: Forty consecutive stable COPD patients with FEV₁ between 59 and 30% of predicted were functionally evaluated by measuring spirometry, maximal flow-volume curve and lung diffusion capacity (DL_CO) and coefficient of diffusion (K_CO). EFL was assessed by the negative expiratory pressure (NEP) method both in sitting and supine position. Chronic dyspnea was also scored by modified Medical Research Council (mMRC) scale. Results: In sitting position 13 patients (33%) were flow limited (FL) and 27 were non-flow limited (NFL). Only FEV₁/FVC, FEV₁ and MEF_25–75% were different between FL and NFL patients (p < 0.01). In supine position, however, among NFL patients in sitting position those who developed EFL, had significantly lower values of DL_CO and K_CO (p < 0.05) and higher mMRC score (p < 0.01), but similar values of FEV₁ as compared to those who did not have EFL. Conclusions: In COPD EFL in sitting position is highly dependent by the severity of airflow obstruction. In contrast, the occurrence of EFL in supine position is associated with worse DL_CO and K_CO and greater chronic dyspnea, reflecting a prevalent emphysematous phenotype in moderate-to-severe COPD patients.     

Small airways ventilation heterogeneity and hyperinflation in COPD: Response to tiotropium bromide

In chronic obstructive pulmonary disease (COPD) patients tiotropium bromide has been shown to improve forced expiratory volume in one second (FEV₁) and inspiratory capacity (IC). We investigated whether the mechanism leading to these improvements is related to small airways ventilation heterogeneity, assessed by multiple breath washout tests. Forty stable tiotropium-free COPD patients (FEV₁: 27%–78% predicted) were studied before and 90 min after administration of tiotropium bromide on visit₀, and following 3 and 6 weeks of tiotropium bromide treatment (visit_3wks, visit_6wks). After study completion, COPD patients were classified into two subgroups according to degree of hyperinflation at visit₀ (Hyp−, Hyp+). The Hyp+ group showed significant increases in trough (ie, pre-dose) FEV₁ and IC after 3 and 6 weeks of tiotropium bromide, and the 90 min tiotropium bromide responses of FEV₁ and IC were significant at visit₀ (p ≤ 0.001 for both) but not during subsequent visits. The Hyp- group showed significant FEV₁ increases 90 min after tiotropium bromide on all three visits (all p < 0.005) but no sustained increase in trough values. In both COPD subgroups, the grossly abnormal ventilation heterogeneity barely showed any significant improvements with tiotropium bromide in the conductive airways (without changes in trough value) and no changes at all in the acinar airways. We conclude that the sustained improvements in trough IC and FEV₁ with tiotropium bromide predominantly observed in COPD patients with considerable hyperinflation, are unrelated to small airways ventilation heterogeneity.     

Long‐term oxygen treatment need is less frequent in eosinophilic COPD patients

IntroductionEosinophilic airway inflammation is a recognized inflammatory pattern in subgroups of patients with chronic obstructive pulmonary disease (COPD). However, there are still conflicting results between various studies concerning the effect of eosinophils in COPD patients. Our aim with this study was to evaluate eosinophilic inflammation and its relation to the clinical characteristics in a group of COPD patients.MethodsStable COPD patients with FEV₁% predicted < 50 or with ≥ 1 exacerbation leading to hospital admission or ≥2 moderate or severe exacerbation history were consecutively enrolled from outpatient clinics.ResultsWe included 90 male COPD patients, with a mean age of 63.3 ± 9.2. Mean FEV₁% predicted was 35.9 ± 11.3. Eosinophilic inflammation (eosinophil percentage ≥2%) was evident in 54 (60%) of the patients. Participants with eosinophilic inflammation were significantly older and had better FEV₁ predicted % values. Eosinophilic COPD patients were characterized with better quality of life and fewer symptoms. COPD patients with noneosinophilic inflammation used supplemental long‐term oxygen therapy (LTOT) more frequently compared to patients with eosinophilic inflammation (36.1% vs. 14.8%, p = 0.01). Eosinophilic inflammation is associated with less dyspnea severity measured by mMRC (OR: 0.542 95% CI: 0.342–0.859, p = 0.009) and less LTOT use (OR: 0.334 95% CI: 0.115–0.968, p = 0.04) regardless of age, severity of airflow limitation, and having frequent exacerbation phenotype.ConclusionOur study supports the growing evidence for a potential role of eosinophilic inflammation phenotype in COPD with distinctive clinical characteristics. Eosinophilic inflammation is inversely associated with dyspnea severity measured by mMRC and LTOT use independently from age, total number of exacerbations, St. George Respiratory Questionnaire (SGRQ) total score and FEV₁% predicted.     

Physical performance in patients with thalassemia before and after transfusion

Patients with thalassemia who are on chronic transfusion programs have chronic ventilatory and cardiocirculatory abnormalities. We studied flow-volume curves, blood gas exchange, and cardiorespiratory responses to exercise in 12 patients with thalassemia major (TM) before and 24 hours after transfusions. Cardiorespiratory fitness was assessed with an exercise tolerance test on a cycle-ergometer. Ten healthy controls underwent the same protocol twice, first at baseline and then 24 hours later, without having had transfusions. We identified two subgroups of patients with a questionnaire: 1) those with no history of airway disease; and 2) those with a history of airway obstruction. Patients with no history of airway disease had normal baseline expiratory flows and no posttransfusion changes; those with a history of airway obstruction had lower pretransfusion expiratory flows rates and significantly decreased posttransfusion forced expiratory volume in 1 second (FEV₁) and forced expiratory flow at 25–75% of forced vital capacity (FEV_25–75%). As a group, TM patients had significantly lower pretransfusion cardiorespiratory function than controls; TM patients' maximum workload was 33% lower, maximum ventilation was 38% lower, maximum oxygen uptake was 25.7% lower, oxygen pulse was 28.6% lower, dyspnea index was 10.6% lower, and ventilatory equivalent for oxygen was 27.1% lower than in control subjects. Although cardiorespiratory responses to exercise improved in both subgroups after transfusion, patients with a history of airways obstruction had a significant posttransfusion increase in their dyspnea index (P = 0.05) and further increased their already abnormally high values of P_ETCO₂ (43 mmHg). These results suggest that the transfusion worsened relative hypoventilation at the maximum workload only in the subgroup with a history of airway obstruction. Pediatr Pulmonol. 1996; 21:367–372. © 1996 Wiley-Liss, Inc.     

New insights into the pathophysiology of mild chronic obstructive pulmonary disease

The classification of mild chronic obstructive pulmonary disease (COPD) requires a postbronchodilator forced expiratory volume in 1 s (FEV₁) to forced vital capacity ratio <0.7 and an FEV₁ ≥80% predicted. Given their relatively well-preserved spirometry, some have argued that respiratory symptoms in patients with mild COPD are unlikely to be related to pulmonary function abnormalities and that early detection of COPD is a ‘waste of resources’. Despite this viewpoint, there is emerging clinical and physiological evidence of peripheral airway dysfunction, diminished quality of life and reduced physical activity levels, and increased mortality, hospitalizations, dyspnea and exercise intolerance in patients with mild COPD compared with healthy controls. The purpose of the present focused review was to summarize recent research regarding the pathophysiology and treatment of mild COPD.     

Evolution of pulmonary function during an acute exacerbation in hospitalized patients with cystic fibrosis

Few objective criteria have been validated for serial clinical monitoring in patients with cystic fibrosis (CF) during pulmonary exacerbations. While pulmonary function tests (PFT) are often used to monitor clinical improvement, it is not known which test correlates most closely with clinical improvement. To answer this, we measured routine PFT in 58 patients with CF before, during, and at discharge after 2–3 week hospital admission in 71 episodes of pulmonary exacerbation. Patients with CF were discharged based on clinical, radiological, and laboratory criteria. In general, all PFTs improved at midadmission and improved further by discharge, at which time forced expiratory volume in 1 second (FEV₁), forced expiratory flow between 25% and 75% of forced vital capacity (FEF_25–75), vital capacity (VC), maximal voluntary ventilation (MVV), and oxygen saturation by pulse oximetry (S_PO2) increased. The residual volume to total capacity ratio (RV/TLC) and the slope of phase 3 in the single breath N, washout curve (SP3 N₂) decreased. The change in SP3 N₂ was significantly greater than in any other PIT (P < 0.01 vs. VC and FEV₁; P < 0.02 vs. RV and P < 0.001 vs. S_PO2). A calculated optimal cut-off value for SP3 N₂ improvement was significantly more sensitive in identifying patient improvement at discharge than any other pulmonary function test (P = 0.005). We speculate that clinical improvement in patients with CF is closely linked to improved distribution of ventilation. Pediatr Pulmonol. 1993; 16:347–353. © 1993 Wiley-Liss, Inc.     

Obesity and COPD: Associated Symptoms,Health-related Quality of Life,and Medication Use

Background: There is little data about the combined effects of COPD and obesity. We compared dyspnea, health-related quality of life (HRQoL), exacerbations, and inhaled medication use among patients who are overweight and obese to those of normal weight with COPD. Methods: We performed secondary data analysis on 364 Veterans with COPD. We categorized subjects by body mass index (BMI). We assessed dyspnea using the Medical Research Council (MRC) dyspnea scale and HRQoL using the St. George's Respiratory Questionnaire. We identified treatment for an exacerbation and inhaled medication use in the past year. We used multiple logistic and linear regression models as appropriate, with adjustment for age, COPD severity, smoking status, and co-morbidities. Results: The majority of our population was male (n = 355, 98%) and either overweight (n = 115, 32%) or obese (n = 138, 38%). Obese and overweight subjects had better lung function (obese: mean FEV₁ 55.4% ±19.9% predicted, overweight: mean FEV₁ 50.0% ±20.4% predicted) than normal weight subjects (mean FEV₁ 44.2% ±19.4% predicted), yet obese subjects reported increased dyspnea [adjusted OR of MRC score ≥2 = 4.91 (95% CI 1.80, 13.39], poorer HRQoL, and were prescribed more inhaled medications than normal weight subjects. There was no difference in any outcome between overweight and normal weight patients. Conclusions: Despite having less severe lung disease, obese patients reported increased dyspnea and poorer HRQoL than normal weight patients. The greater number of inhaled medications prescribed for obese patients may represent overuse. Obese patients with COPD likely need alternative strategies for symptom control in addition to those currently recommended.     

Exhaled Nitric Oxide and Exercise-Induced Bronchospasm Assessed by FEV1, FEF25 − 75% in Childhood Asthma

The relationship between exhaled nitric oxide (eNO) and bronchial hyperresponsiveness (BHR) should be clarified. The aim of this study was to determine the relationship between eNO and exercise-induced bronchospasm (EIB) by estimation of the each lung parameter in asthmatic children who performed a bicycle ergometer exercise test. Twenty children with asthma were recruited. eNO concentration was examined by the recommended online method. To evaluate BHR, an exercise stress test was performed on a bicycle ergometer. The mean baseline eNO value was significantly correlated with the mean maximum % fall in forced expiratory volume in 1 second (FEV₁), forced expiratory flow between 25% and 75% (FEF25-75%) after exercise (r = 0.53, r = 0.65, respectively). eNO in the EIB-positive group was significantly higher than that in the EIB-negative group by assessing FEV₁, FEF_25?75% (p < 0.005, p = 0.005). We demonstrated that the most important lung parameter assessed the occurrence of EIB by a bicycle ergometer exercise test was not only FEV₁ but FEF_25?75%, which significantly correlated with eNO. This suggests that not only FEV₁ but FEF_25?75% can be used to evaluate the correlations between BHR (EIB) and airway inflammation (eNO) in asthmatic children. A low eNO is useful for a negative predictor for EIB.     

Roflumilast in Asian patients with COPD: A randomized placebo-controlled trial

Background and objective: Roflumilast, an oral, selective phosphodiesterase 4 inhibitor, has been shown to reduce exacerbations and improve pulmonary function in patients with COPD. This study examined the efficacy, safety and tolerability of roflumilast in Asian patients with COPD. Methods: Patients with COPD were randomized 1:1 to enter a 12‐week treatment period and receive either oral roflumilast, 500 µg once daily, or placebo, following a single‐blind, 4‐week baseline period in which all patients received placebo. The primary end point was mean change in FEV₁ from baseline to each postrandomization visit during the treatment period. Other spirometric lung function measurements were evaluated as secondary end points. COPD exacerbations were monitored. Safety was assessed from clinical laboratory tests, vital signs, physical examination (including electrocardiogram) and monitoring of adverse events (AEs). Results: Of 551 patients recruited, 410 were randomized and received at least one dose of study medication (roflumilast, n = 203; placebo, n = 207). Superiority of roflumilast over placebo was demonstrated by a statistically significant difference in postbronchodilator FEV₁ (79 mL, P < 0.0001). Other spirometry end points, including prebronchodilator FEV₁, pre‐and postbronchodilator FEV₆, forced vital capacity and peak expiratory flow significantly favoured roflumilast over placebo. AEs were more common with roflumilast than with placebo, but were comparable with those reported in previous studies. Conclusions: Roflumilast, 500 µg once daily, improves pulmonary function in Asian patients with COPD. The safety and tolerability of roflumilast in this population was similar to that in a Caucasian population.