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Smokers who have severe alpha-1 antitrypsin deficiency (AATD) are at risk for developing COPD earlier in life than smokers without AATD, and are likely to experience challenges adjusting to their illness because they are in a highly productive life stage when they are diagnosed with COPD. This study examined whether individuals with AATD-associated COPD differ from individuals with non-AATD COPD with regard to depression, anxiety, dyspnea, and health-related quality of life (HRQL).

Cross-sectional data were collected via self-report questionnaires completed by 480 individuals with non-AATD COPD and 578 individuals with AATD-associated COPD under protocols with IRB approval. Multiple linear regression models were used to test whether individuals with non-AATD COPD differed from individuals with AATD-associated COPD with regard to depression, anxiety, dyspnea, and HRQL. All models adjusted for demographic and health characteristics.

Individuals with AATD-associated COPD did not report more symptoms of depression or anxiety; however, they did report more dyspnea (B = 0.31, 95% CI = 0.16 to 0.47, p < 0.001) and impairment in HRQL (B = 4.75, 95% CI = 2.10 to 7.41, p < 0.001) than other individuals with COPD. Individuals with AATD-associated COPD were more likely to be a member of a couple (rather than single) and had a higher level of education when compared to individuals with non-AATD COPD.

Resources available to persons with AATD-associated COPD, such as being in a serious relationship and having higher education, may offset the effect of age when considering symptoms of depression and anxiety in patients with COPD.

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The efficacy and tolerability of budesonide/formoterol vs. formoterol in patients with moderate to severe chronic obstructive pulmonary disease (COPD) was evaluated.

METHODS: In this randomised, double-blind, parallel-group, phase III study (NCT01069289) patients with moderate to severe COPD for ≥2 years received either budesonide/formoterol 160/4.5 μg 2 inhalations twice daily (bid) via Turbuhaler(®) or formoterol 4.5 μg 2 inhalations bid via Turbuhaler(®) for 12 weeks. Salbutamol 100 μg/actuation via pMDI was available as reliever medication. Primary outcome variable: change from baseline to average during treatment in pre-dose FEV1 ; secondary outcome variables included lung function, COPD symptom measures, time to first exacerbation and tolerability.

RESULTS: 1293 patients were randomised (budesonide/formoterol n=636; formoterol n=657). Both budesonide/formoterol and formoterol increased pre-dose FEV1 vs. baseline (improvements of 4.6% and 1.5% over baseline, respectively), with the increase from baseline being significantly greater with budesonide/formoterol vs. formoterol (budesonide/formoterol:formoterol ratio 1.032; 95% CI: 1.013-1.052; p=0.0011). The budesonide/formoterol group had a significantly prolonged time to first exacerbation vs. the formoterol group (hazard ratio: 0.679; 95% CI: 0.507-0.909; p=0.0094) and significantly greater improvements in many secondary outcome measures. Both treatments were well tolerated; the incidence and type of adverse events were similar to most commonly reported adverse events (budesonide/formoterol vs. formoterol): COPD (8.0% vs. 9.4%) and nasopharyngitis (5.5% vs. 4.9%).

CONCLUSIONS: Budesonide/formoterol 160/4.5 μg two inhalations bid was effective and well tolerated in patients with moderate to severe COPD, offering benefits over formoterol alone in terms of improved lung function and reduced risk of exacerbation.

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QUESTION Is amoxicillin plus clavulanate effective for moderate exacerbations of mild-to-moderate chronic obstructive pulmonary disease (COPD)?

METHODS DESIGN Randomized placebo-controlled trial (RCT). ClinicalTrials.gov NCT00495586.

ALLOCATION {Concealed}*.† BLINDING Blinded† (patients, investigators, {health care providers, data collectors, and data analysts}*).

FOLLOW-UP PERIOD 9 to 11 days, 20 days, and 1 year.

SETTING 13 primary care centers in Catalonia, Spain.
PATIENTS 318 outpatients ≥ 40 years of age (mean age 68 y, 81% men) who had an exacerbation (≥ 1 of increased dyspnea, increased sputum volume, or sputum purulence) of mild-to-moderate COPD (≥ 10 pack-y smoking history, postbronchodilator FEV1/FVC &lt; 70%, and postbronchodilator FEV1 &gt; 50% of predicted value). Exclusion criteria included need for hospitalization; antibiotic use in the past 2 weeks; hypersensitivity to β-lactams, clavulanate, or lactose; immunosuppression; bronchial asthma; cystic fibrosis; active neoplasm; bronchiectasis due to conditions other than COPD; or tracheotomy.

INTERVENTION Amoxicillin/clavulanate, 500/125 mg (n = 162), or placebo (n = 156), 3 times/d for 8 days. Oral corticosteroids (≤ 60 mg/d) for ≤ 10 days could be used in both groups.

OUTCOMES Primary outcome was clinical cure (disappearance of infection-related acute signs and symptoms and return to stability) at 9 to 11 days. Other outcomes included clinical success (cure or improvement [incomplete symptom resolution without need for another medication or intervention]) and time to next exacerbation.

PATIENT FOLLOW-UP 97% (intention-to-treat analysis).

MAIN RESULTS Oral corticosteroids were used in 16% of patients in the amoxicillin group and 18% in the placebo group. Amoxicillin/clavulanate increased clinical cure and clinical success rates at 9 to 11 days and at 20 days compared with placebo (Table). Time to next exacerbation was longer with amoxicillin/clavulanate than with placebo (median 233 vs 160 d, P = 0.015).

CONCLUSION Amoxicillin/clavulanate improved clinical cure rate and increased time to next exacerbation compared with placebo in patients with moderate exacerbation of mild-to-moderate chronic obstructive pulmonary disease.Amoxicillin/clavulanate (AMX) vs placebo for moderate exacerbations of mild-to-moderate chronic obstructive pulmonary disease‡OutcomesAMXPlaceboRBI (95% CI)NNT (CI)Clinical cure§ at 9 to 11 d74%60%24% (6 to 46)8 (5 to 27)Clinical success|| at 9 to 11 d91%81%12% (2 to 24)11 (6 to 55)Clinical cure§ at 20 d82%68%20% (6 to 38)8 (5 to 24)Clinical success|| at 20 d91%80%13% (3 to 25)10 (6 to 41)‡Abbreviations defined in Glossary. RBI, NNT, and CI calculated from event rates in article.§Disappearance of infection-related acute signs and symptoms and return to stability.||Cure or improvement (incomplete symptom resolution without need for another medication or intervention).

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Seasonal variations in the acute exacerbation of chronic obstructive pulmonary disease (COPD) have been reported. However, the influence of air temperature and other meteorological factors on COPD exacerbation remains unclear.

METHODS: National Health Insurance registry data from January 1, 1999 to December 1, 2009 and meteorological variables from the Taiwan Central Weather Bureau for the same period were analyzed. A case-crossover study design was used to investigate the association between COPD exacerbation and meteorological variables.

RESULTS: A total of 16,254 cases who suffered from COPD exacerbation were enrolled. We found that a 1°C decrease in air temperature was associated with a 0.8% increase in the exacerbation rate on event-days (95% confidence interval (CI), 1.015-1.138, p = 0.015). With a 5°C decrease in mean temperature, the cold temperature (28-day average temperature) had a long-term effect on the exacerbation of COPD (odds ratio (OR), 1.106, 95% CI 1.063-1.152, p<0.001). In addition, elderly patients and those who did not receive inhaled medication tended to suffer an exacerbation when the mean temperature dropped 5°C. Higher barometric pressure, more hours of sunshine, and lower humidity were associated with an increase in COPD exacerbation.

CONCLUSIONS: This study demonstrated the effect of cold temperatures on the COPD exacerbation rate. Elderly patients and those without inhaled medicine before the exacerbation event were affected significantly by lower mean temperatures. A more comprehensive program to prevent cold stress in COPD patients may lead to a reduction in the exacerbations rate of COPD.

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