N-乙酰半胱氨酸联合茶碱缓释片治疗COPD稳定期疗效观察

目的探讨慢性阻塞性肺疾病稳定期患者的有效治疗方法，以减少COPD急性发作。方法将32例COPD稳定期病人随机分成两组，试验组给予茶碱缓释片0．2口服目2次，N-乙酰半胱氨酸（N—acetylcysteine，NAG）200mg口服目3次。对照组给予茶碱缓释片0．2口服日2次。疗程为6个月。观察肺功能，患者急性发作次数。结果在试验组肺功能较试验前均有显著提高（P均〈0．01），6个月后COPD急性发作次数减少（P〈0．01）。结论茶碱缓释片联合NAC治疗能够改善稳定期COPD患者的肺功能及急性发作次数。     

吸入糖皮质激素联合茶碱治疗慢性阻塞性肺病的疗效观察

目的观察吸入糖皮质激素和口服小剂量缓释茶碱治疗重度慢性阻塞性肺病（COPD）的疗效。方法对30例重度COPD稳定期患者给予吸入布地奈德气雾剂和口服缓释茶碱6月，评估肺功能、症状、慢性阻塞性肺疾病急性发作（AECOPD）情况和不良反应等，并和30例时照组比较。结果们地奈德和茶碱治疗6月后肺通气功能和症状较治疗前显著改善（P〈0．05），和对照绀比较差异有统计学意义（P〈0．05），发生AECOPD的例数较对照组减少（P〈0．05），治疗组有2例开始出现声嘶，以后消失。结论吸入布地奈德气雾剂和口服小剂量缓释茶碱治疗重度稳定期COPD安全有效。     

舒利迭吸入辅助治疗COPD稳定期患者46例效果观察

将同期收治的80例慢性阻塞性肺疾病（COPD）稳定期患者随机分为观察组46例和对照组34例,两组均予COPD常规治疗,在此基础上观察组予舒利迭吸入,每次1喷,2次／d;对照组口服茶碱缓释片0．1g,2次／d,并酌情予沙丁胺醇（万托林）气雾剂,疗程均为8周。观察两组治疗前后肺功能、血气指标及临床症状评分改善情况。结果治疗后观察组肺功能、血气指标及临床症状评分改善情况均明显优于对照组（P〈0．05）。认为舒利迭吸入能明显改善COPD稳定期患者肺功能及临床症状。     

信必可都保吸入治疗COPD稳定期患者临床分析

目的观察信必可都保吸入治疗COPD稳定期患者疗效。方法 2006年~2008年收治的80例慢性阻塞性肺疾病（COPD）稳定期患者随机分为观察组44例和对照组36例,两组均予COPD常规治疗,在此基础上观察组予信必可都保吸入,每次1喷,2次/d;对照组口服茶碱缓释片0.1 g,2次/d,并酌情予沙丁胺醇（万托林）气雾剂,疗程均为12周。观察两组治疗前后肺功能、血气指标及不良反应情况。结果治疗后观察组肺功能、血气指标改善情况均明显优于对照组（P〈0.05）,不良反应少。结论信必可都保吸入能明显改善COPD稳定期患者肺功能及血气指标。     

噻托溴胺治疗稳定期COPD

目的观察噻托嗅胺对稳定期慢性阻塞性肺疾病（COPD）患者的临床疗效。方法 40例稳定期COPD患者随机分成两组,实验组应用噻托嗅铵18 ug吸入,1次/天,对照组口服茶碱缓释片100 mg,2次/天.观察记录患者治疗前后肺功能、6min步行距离、生活质量评分。结果两组治疗后肺功能、临床症状等较治疗前均有好转,但实验组较对照组FEVl占预计值百分比明显增加,生活质量明显改善,6 min步行距离、临床症状明显改善。两组治疗前后各项指标比较,差异具有统计学意义（P〈0.05或P〈0.01）。结论长期规律吸入噻托溴胺可有效改善慢阻肺患者肺功能并缓解临床症状,提高患者的生活质量。     

布地奈德吸人对老年中重度COPD患者临床症状积分及肺功能的影响

目的观察舒利迭吸入治疗老年中重度慢性阻塞性肺疾病（COPD）的效果及安全性。方法将同期收治的1．50例COPD患者随机分为观察组和对照组各75例,在常规治疗基础上分别予舒利迭气雾剂吸入及茶碱缓释片121服、布地奈德气雾剂吸人治疗,疗程均为8周。治疗前后观察两组临床症状积分、肺功能指标[1s用力呼气容积（FEV1）、用力肺活量（FVC）]及不良反应发生情况。结果治疗后观察组临床症状积分显著低于治疗前及对照组（P〈0．05）;观察组FEV1、FEV1／FVC、FEV1％均显著大于治疗前,且FEV1、FVC显著高于对照组,P均〈0．05;两组均无明显不良反应。结论舒利迭吸入治疗可明显改善中重度CDPD患者临床症状及肺功能,且无明显全身不良反应。     

吸入糖皮质激素治疗稳定期COPD临床研究

采用随机数字法将稳定期慢性阻塞性肺疾病（COPD）患者分为两组，观察组在常规治疗基础上吸入布地奈德，对照组仅采用常规治疗，疗程均半年。结果显示，观察组呼吸困难评分、6min步行距离、生活质量评分、第1秒用力呼气容积等指标均较对照组明显改善（P〈0．05），且急性加重患者的门诊和住院人次较对照组少（P〈0．05）。认为吸入中等剂量布地奈德可减轻稳定期COPD患者的临床症状，改善活动耐力、生活质量和肺功能，减少急性加重次数。     

布地奈德／福莫特罗吸入剂对老年COPD稳定期患者生活质量的影响

目的探讨布地奈德／福莫特罗吸入剂吸入治疗对老年COPD稳定期患者生活质量的影响。方法确诊COPD老年患者共36例,分为治疗组16例,对照组20例,治疗组予以布地奈德／福莫特罗吸入剂吸入治疗,对照组不进行特殊治疗,疗程6个月,观察肺功能、6-MWT、SF-36生活质量调查表的得分对比变化。结果治疗组肺功能、6-MWT与对照组比较均有好转（P〈0．05）,治疗组SF-36生活质量调查表的躯体功能,躯体角色,健康总体自评,生命活力,肌体疼痛、社会功能等6个方面得分高于治疗前（P〈0．05）且与对照组比较有改善（P〈0．05）。而情感角色和心理健康2个方面与在治疗前相比差别无统计学意义（P〉0．05）。结论布地奈德／福莫特罗吸入剂吸入治疗是老年COPD患者稳定期有效的治疗方案,长期吸入治疗能延缓其肺功能的损害,提高生活质量、增加运动耐量。     

舒利迭吸入治疗慢性阻塞性肺疾病

目的观察舒利迭吸入治疗慢性阻塞忡肺疚病临床疗效。方法门诊确诊COPD患者共52例，分为治疗组28例，对照组24例，分别给于吸入舒利达治疗和口服茶碱治疗8周，观察肺功能、动脉血气、临床症状评分对比变化。结果治疗组肺功能、动脉血气、临床症状评分较对照组比较均有好转（P〈0．05）。结论舒利迭吸入治疗是中再度稳定期COPD患者有效的治疗方案，长期吸入治疗能减缓肺功能的损害，缓解临床疗状。     

综合性肺康复治疗对稳定期COPD患者肺功能及血气指标的影响

将同期收治的60例慢性阻塞性肺疾病（COPD）稳定期患者随机分为观察组和对照组各30例，两组均予COPD基础治疗，观察组在此基础上给予呼吸功能锻炼、呼吸体操、有氧训练、氧疗、营养支持、心理与行为干预和教育等综合性肺康复治疗，观察两组肺功能及血气指标变化。结果观察组治疗前、后肺功能及血气指标均明显改善，效果优于对照组（P〈0．05）。认为综合性肺康复治疗有利于提高稳定期COPD患者的生存质量。     

Positive benefits of theophylline in a randomized, double-blind, parallel-group, placebo-controlled study of low-dose, slow-release theophylline in the treatment of COPD for 1 year

OBJECTIVE AND BACKGROUND: Increasing evidence suggests that low-dose theophylline has anti-inflammatory benefits and is safe in the treatment of COPD. This study aims to evaluate the efficacy and safety of low-dose, slow-release oral theophylline administered over a 1-year period in patients with COPD. METHODS: A randomized, double-blind, parallel-group, placebo-controlled trial was carried out. In total, 110 participants with COPD were randomly assigned to receive slow-release theophylline (100 mg b.i.d.) or placebo for 1 year. Use of medicine and symptoms recorded by diary cards; pulmonary function, exacerbations of COPD, quality of life and the use of rescue medicine were evaluated. Superiority test was used to estimate the efficacy. RESULTS: Of 110 participants, 85 (77.3%) complied with the protocol, with 42 subjects in theophylline and 43 subjects on placebo. In both intention-to-treat and per-protocol population analysis, greater improvement in pre-bronchodilator FEV(1) (P = 0.038 and P = 0.070, respectively), lower frequency of COPD exacerbations (P = 0.047 and P = 0.035, respectively), fewer days of COPD exacerbations (P = 0.045 and P = 0.046, respectively), lower frequency of clinical visits (P = 0.017 and P = 0.039, respectively), greater improvement in satisfaction with treatment (P = 0.014 and P = 0.004, respectively) were found in the theophylline group than in the placebo group. In per-protocol population, greater improvements in quality of life (P = 0.047) were also observed in the theophylline group and the mean time to the first exacerbation was delayed in theophylline group in comparison with placebo group (P = 0.047). Drug-related adverse events such as stomach discomfort (3.51%), headache (3.51%), insomnia (1.75%) and palpitation (1.75%) were found in the theophylline group. CONCLUSIONS: Low-dose, slow-release oral theophylline is effective and well-tolerated in the long term treatment of stable COPD, although it does not improve post-bronchodilator lung function.     

Salmeterol plus theophylline combination therapy in the treatment of COPD

BACKGROUND: Patients with COPD often require multiple therapies to improve lung function and decrease symptoms and exacerbations. Salmeterol and theophylline are indicated for the treatment of COPD, but the use of these agents in combination has not been extensively studied. OBJECTIVES: To compare the efficacy and safety of salmeterol plus theophylline vs either agent alone in COPD. METHODS: Randomized, double-blind, double-dummy, parallel-group trial in 943 patients with COPD. After an open-label theophylline titration period (serum levels, 10 to 20 microg/mL), patients were randomly assigned to receive salmeterol (42 microg bid) plus theophylline, salmeterol (42 microg bid), or theophylline for 12 weeks. Serial pulmonary function tests were completed on day 1 and treatment week 12. Patients kept diary cards and noted their peak flow rates, symptom scores, and albuterol use, and periodically completed quality-of-life and dyspnea questionnaires. RESULTS: All three groups significantly improved compared with baseline. Combination treatment with salmeterol plus theophylline provided significantly (p < or = 0.045) greater improvements in pulmonary function; significantly (p < or = 0.048) greater decreases in symptoms, dyspnea, and albuterol use; and significantly fewer COPD exacerbations (p = 0.023 vs theophylline). In general, treatment with salmeterol provided greater improvement in lung function and satisfaction with treatment compared with theophylline. Salmeterol treatment was also associated with significantly fewer drug-related adverse events (p < or = 0.042) than either treatment that included theophylline. The safety profile (adverse events, vital signs, and ECG findings) of the two treatments that included theophylline were similar. CONCLUSION: Patients with COPD may benefit from combination treatment with salmeterol plus theophylline, without a resulting increase in adverse events or other adverse sequelae.     

茶碱治疗慢性阻塞性肺疾病的随机双盲平行对照研究

目的观察长期口服小剂量缓释茶碱治疗稳定期慢性阻塞性肺疾病(COPD)的疗效和安全性。方法采用随机双盲安慰剂平行对照研究方法,对2002至2003年广东韶关农村地区流行调查中筛选出符合入选标准的110例稳定期 COPD 患者进行简单随机分组,分别予缓释茶碱(每次100 mg,每天2次)和安慰剂口服治疗1年。评估肺功能、慢性阻塞性肺疾病急性发作(AECOPD)情况、生活质量、气促分数、治疗满意度和不良反应等。疗效比较采用优势检验。结果 85例(缓释茶碱组42例,对照组43例)完成1年随访。目标治疗(ITT)人群分析结果显示,缓释茶碱组 AECOPD总次数[(0.8±1.2)次/年]较安慰剂组[(1.7±2.6)次/年]减少(Z=-1.674,P=0.047),AECOPD总时间[(4.6±7.9)d]较安慰剂组[(12.5±22.8)d]减少(Z=-1.699,P=0.045);中度及以上AECOPD 次数[(0.4±1.0)次/年]较安慰剂组[(1.0±1.8)次/年]显著减少(Z=-2.136,P=0.017),扩张前的第一秒用力呼气容积(FEV_1)递减值[(0.006±0.180)L]较安慰剂组[(-0.503±0.169)L]显著减少(t=1.789,P=0.038),疗效总满意度(其中对疗效很满意的患者16例)较安慰剂组(对疗效很满意患者3例)高(Z=-2.198,P=0.014),首次 AECOPD 时间(中位数表示,365 d)较安慰剂组(276 d)延迟(X~2=3.880,P=0.049),但两组支气管扩张试验后的 FEV_1递减值(t=-0.012,P=0.495)和不良反应(P=0.076)比较差异均无统计学意义。符合方案(PP)人群分析结果显示类似的结果,缓释茶碱组的生活质量[(-28±20)分]较安慰剂组[(-20±23)分]显著改善(F=2.893,P=0.047)。结论小剂量缓释茶碱长期治疗稳定期 COPD 安全有效。     

沙美特罗替卡松对重度COPD患者的疗效观察

目的观察长期吸入沙美特罗替卡松对稳定期重度COPD患者肺功能、血气指标、TNF-α及生活质量等的影响。方法选取在我院治疗的78例重度COPD患者随机分为对照组39例、试验组39例。对照组口服茶碱缓释胶囊并按需使用短效支扩剂;试验组在此基础上给予沙美特罗替卡松(50/500μg)吸入治疗。对两组治疗1个月、6个月的肺功能指标、血气指标、痰液TNF-α水平及SGRQ评分改善进行统计比较。结果试验组6个月后FEV1及FEV1/FVC较对照组有明显改善;试验组呼吸困难明显改善;治疗后1个月、6个月时试验组的血气、肺功能指标及SGRQ评分结果均优于对照组,而试验组痰液TNF-α水平均低于对照组,有显著性差异(P<0.05)。结论沙美特罗替卡松吸入治疗稳定期重度COPD,能够显著改善肺功能,明显缓解临床症状,显著提高患者生活质量。     

低体质指数的慢性阻塞性肺疾病患者临床和实验室研究

目的 探讨低体质指数(BMI)的慢性阻塞性肺疾病(COPD)患者的临床特征及与COPD患者BMI相关的因素. 方法 选取中、重度稳定期COPD患者38例,测量身高、体质量,按BMI分为低体质量组:16例,BMI<20}正常体质量组22例,20≤BMI<26.所有患者行肺功能检查;记录吸烟指数;测6 min步行距离(6MWD);采用英国医学研究委员会呼吸困难量表(MRC)记录气促分级并评分;St George's呼吸问卷(SGRQ)和一般健康状况调查问卷(SF-36)评价生活质量,用酶联免疫吸附试验(ELISA)测定血清瘦素、格列林的水平. 结果 低体质量组与正常体质量组比较,深吸气量(IC)明显降低(P<0.01);第1秒用力呼气量(FEVl)、肺活量(VC)、最大通气量(MVV)、最大呼气峰值流速(PEF)均下降(P<0.05);残气量与肺总量比值(RV/TLC)明显增高(P<0.01).低体质量组吸烟指数增加,6MWD减少(P<0.05),MRC气促评分增高(P<0.01).低体质量组SGRQ评分中活动分、影响分与总均分增高(P<0.05),SF-36量表中情感职能、社会功能评分明显减低(P<0.05).低体质量组瘦素水平明显降低(P<0.01),格列林水平增高(P<0.05).经多元逐步回归分析发现,与BMI独立相关的因素分别是:IC、SF-36量表的精神健康和生理机能、瘦索、6MWD、吸烟指数. 结论 低BMI COPD患者肺功能、营养状况、运动能力及生活质量较正常BMI患者下降;IC与BMI关系最密切,患者的精神健康、运动能力、血清瘦素水平、吸烟指数均与BMI独立相关;纠正低BMI应为COPD综合治疗的重要组成部分.     

A comparison between inhaled salmeterol and theophylline in the short-term treatment of stable chronic obstructive pulmonary disease

BACKGROUND: International guidelines indicate that the long-acting bronchodilators play a key role in the treatment of patients with chronic obstructive pulmonary disease (COPD). The aim of this study was to assess the short term efficacy and safety of 50 and 100 microg bid inhaled salmeterol, compared with placebo and orally dose titrated slow-release theophylline in patients with stable COPD. METHODS: Thirteen patients (67+/-7 years, three females) with moderate-to-severe COPD (FEV1<70% predicted and >30% predicted) and with poor reversibility (post-bronchodilator FEV1<12% and <200 ml from pre-bronchodilator values) completed this single centre randomised, double-blind, double-dummy, four-phase cross-over clinical trial. Patients were randomised to treatment after a 2-week oral corticosteroid trial and a theophylline titration phase. Each treatment lasted 2 week with a 2-week washout period. Values at the end of treatments were compared. RESULTS: Inhaled salmeterol at both tested doses was better than placebo in improving lung function (FEV1, FVC, and morning PEF) of stable patients with moderate COPD over a period of 2 weeks. Although slight (about 170 ml, 150 ml, and 120 ml/min on average, for FEV1, FVC, and PEF, respectively) the improvement was significant. The effects seem to improve only slightly with the higher dose. Salmeterol appeared to be more effective than theophylline treatment when compared to placebo, as theophylline improved significantly, but less, the FEV1 (about 80 ml, on average) without affecting any of the other lung function variables. Salmeterol 100 microg was significantly better than theophylline in improving morning PEF. Four patients reported five adverse events while receiving placebo and 2 and 3 patients reported 2 and 3 adverse events, respectively, during salmeterol 50 microg and salmeterol 100 microg phases. None was considered drug related. Five patients experienced 13 adverse events with theophylline treatment, four of which were considered drug related. CONCLUSION: Inhaled salmeterol improves lung function in stable patients with moderate-to-severe and poorly reversible COPD. The magnitude of improvement in FEV1 observed in this study is similar to that found in longer and larger studies on similar populations of patients. In those studies, that improvement was associated with a better quality of life and less symptoms. Theophylline determined a smaller improvement in FEV1 with more unpleasant side effects that both doses of inhaled salmeterol, though there was no significant difference. It is concluded that salmeterol is an effective and well tolerated therapy, potentially preferable to theophylline, at least in the short-term management of stable COPD.     

慢性阻塞性肺疾病患者稳定期肺功能与生活质量的关系

目的观察慢性阻塞性肺疾病（COPD）稳定期肺功能与生活质量的关系。方法采用美国波士顿健康研究所研制的简明健康调查问卷SF-12对入选223例COPD患者行问卷调查,计算不同COPD分级的躯体成分（PCS）评分和精神成分（MCS）评分。根据支气管舒张试验将COPD患者223例分为支气管舒张试验阳性和阴性两组,观察患者肺功能与生活质量的关系。结果COPD患者PCS及MCS评分与COPD分级呈负相关（rPCS=-0.282,P〈0.05;rMCS=-0.172,P〈0.05）。223例患者支气管舒张试验阳性77例,阴性146例。支气管舒张试验阳性者PCS评分高于阴性者（t=3.331,P〈0.01）。结论COPD患者肺功能与生活质量密切相关,肺功能联合生活质量评价能更全面地反映患者病情的严重程度。     

百令胶囊联合布地奈德福莫特罗粉吸入剂治疗稳定期慢性阻塞性肺疾病的疗效及机制

目的观察百令胶囊对稳定期慢性阻塞性肺疾病(慢阻肺)患者的生活质量、肺功能和免疫功能的影响。方法将150例稳定期慢阻肺患者按照随机原则分为对照组和中药组各75例,对照组给予布地奈德福莫特罗,每次1吸(160ug/4.5ug),每日2次;中药组另加用百令胶囊,每次4粒,每日3次,疗程8周。观察两组治疗前后症状评分、肺功能和免疫功能变化;采用圣乔治呼吸困难问卷(SGRQ)量表在治疗前后对两组病例进行生活质量评估。结果:1中药组和对照组总有效率分别为89.33%和74.67%(P0.05);2治疗后中药组第1秒呼气容积(FEV_1)、第1秒用力呼气容积与预计值百分比(FEV_1pred%)和第1秒用力呼气容积与用力肺活量比值(FEV_1/FVC)显著升高,且优于对照组(P0.05);3治疗后中药组SGRQ评分明显低于对照组(P0.05);4治疗后中药组Th17%和Th17/Treg降低显著优于对照组(P0.05)。结论百令胶囊联合布地奈德福莫特罗治疗稳定期慢阻肺疗效肯定,可有效缓解临床症状,改善肺功能和免疫功能,提高生活质量。     

Formoterol: a review of its use in chronic obstructive pulmonary disease

Inhaled formoterol is a long-acting selective beta2-adrenoceptor agonist, with an onset of action of 5 minutes postdose and a bronchodilator effect that lasts for at least 12 hours. Statistically significant and clinically relevant (>120 ml) improvements in lung function [assessed using standardized/normalized area under the forced expiratory volume in 1 second (FEV1) versus time curve (AUC FEV1)] were observed with inhaled formoterol 12 microg twice daily (the approved dosage in the US) compared with placebo in 12-week and 12-month, randomized, double-blind trials in patients with chronic obstructive pulmonary disease (COPD). The bronchodilator efficacy of formoterol 12 microg twice daily was greater than that of oral slow-release theophylline (individualized dosages) in a 12-month trial or inhaled ipratropium bromide 40 microg four times daily in a 12-week trial. Improvement in AUC FEV1 with formoterol, but not theophylline, compared with placebo was observed in patients with irreversible or poorly-reversible airflow obstruction. Formoterol also significantly improved health-related quality of life compared with ipratropium bromide or placebo and significantly reduced symptoms compared with placebo. Combination therapy with formoterol 12 microg twice daily plus ipratropium bromide 40 microg four times daily was significantly more effective than albuterol (salbutamol) 200 microg four times daily plus the same dosage of ipratropium bromide in a 3-week, randomized, double-blind, double-dummy, crossover trial. Inhaled formoterol was well tolerated in clinical trials. The incidence of investigator-determined drug-related adverse events with inhaled formoterol 12 microg twice daily was similar to that with placebo and inhaled ipratropium bromide 40 microg four times daily but lower than that with oral slow-release theophylline (individualized dosages). Importantly, there were no significant differences between formoterol and placebo or comparator drugs in cardiovascular adverse events in patients with COPD and corrected QT interval values within the normal range. In conclusion, inhaled formoterol improved lung function and health-related quality of life and reduced symptoms relative to placebo in clinical trials in patients with COPD. The drug had greater bronchodilator efficacy than oral slow-release theophylline or inhaled ipratropium bromide and showed efficacy in combination with ipratropium bromide. The adverse events profile (including cardiovascular adverse events) with formoterol was similar to that with placebo. Thus, inhaled formoterol may be considered as a first-line option for the management of bronchoconstriction in patients with COPD who require regular bronchodilator therapy for the management of symptoms.     

Efficacy and safety of oxitropium bromide,theophylline and their combination in COPD patients: a double-blind,randomized, multicentre study (BREATH Trial)

We compare the efficacy including spirometry, peak expiratory flow (PEFR) and quality of life and safety of an 8-week treatment with inhaled oxitropium, theophylline or their combination in patients with mild-to-severe chronic obstructive pulmonary disease (COPD). We conducted a multicentre, double-blind, double-dummy randomized, parallel-group study at 29 Italian outpatients clinics. A group of 236 patients with mild-to-severe COPD (baseline FEV1 < or = 70% of predicted value) were recruited. Treatments were as follows: Inhaled oxitropium bromide 200 microg (N=75), sustained-release oral theophylline 300 mg (N=81) or their combination (N=80), taken twice daily. Spirometry (FEV1 and FVC) was evaluated every 4 weeks, and morning and evening PEFR (before and 2-4 h after drug intake) was measured daily. Symptoms, cough and dysponea, were recorded daily. Health status was evaluated at baseline and week 8 using the disease specific St George' Respiratory Questionnaire (SGRQ). Any adverse event occurring during the treatment period was recorded on a diary card. FEV1 and FVC improved in all the groups at 4 and 8 weeks, but the difference between treatment groups did not reach statistically significant levels. Differences between groups in pre-dosing morning and evening PEFR were not significant. Post-dosing morning and evening PEFR were increased and the largest increase was seen in patients treated with both drugs. However, differences between groups was significant only for evening values (P=0.008). The proportion of patients who experienced a decrease in symptoms was high in all groups but no differences among groups were observed. SGRQ total scores decreased in all treatment groups after 8 weeks, particularly in the oxitropium and combination groups. Clinically significant change (> or = 4 units) was only observed in patients treated with oxitropium bromide whether with or without theophylline. Adverse events related to treatments were higher in the group treated with theophylline alone (P < 0.02). We conclude that inhaled oxitropium bromide alone was associated with an improvement in FEV1, PEFR and symptoms in patients with COPD that was not statistically different from that of oral theophylline alone or of the combination of both drugs. Oxitropium bromide in combination with theophylline provided a greater improvement in evening post-dosing PEFR. Oxitropium bromide alone or in combination with theophylline improved the quality of life better than theophylline alone.