COPD
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Randomized Controlled Trial Multicenter Study
The safety and efficacy of arformoterol and formoterol in COPD.
This study evaluated the safety and efficacy of arformoterol and formoterol over 6-months in subjects with COPD. In a multi-center, 6-month randomized, double-blind, double-dummy trial, subjects with COPD (mean FEV(1) 1.21 L, approximately 41.0% predicted) were randomized to receive either nebulized arformoterol (15 microg BID [n = 149][ARF 15], 25 microg BID [n = 147][ARF 25]), or racemic formoterol (12 microg BID [n = 147][FORM]) delivered by DPI. The proportion of subjects with any post-treatment adverse event for ARF 15, ARF 25 microg, and FORM was 67.8%, 76.2% and 66.7%, respectively, and those with at least one COPD exacerbation was 32.2%, 30.6%, and 22.4%, respectively. ⋯ Dyspnea, (mean Transition Dypsnea Index (TDI) focal score) improved in all treatment arms (ARF 15: 1.4, ARF 25: 1.5, and FORM: 1.4) at 6 months, as did rescue short-acting beta(2)-agonists use (mean range: -1.1 to -1.3 actuations/day) and ipratropium bromide (mean range: -0.3 to -0.8 actuations/day). Health status, measured by St George's Respiratory Questionnaire, improved from baseline at 6-months in all treatment groups (mean change: -3.7 to -6.8). In this 6-month study, arformoterol and formoterol were well-tolerated, and their use was associated with improvement in pulmonary function and health status in subjects with COPD with no apparent development of tolerance.
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Randomized Controlled Trial Multicenter Study Comparative Study
Effect of nebulized arformoterol on airway function in COPD: results from two randomized trials.
Arformoterol, a single isomer long-acting beta(2)-agonist, was developed as an inhalation solution for the maintenance treatment of bronchoconstriction in COPD. ⋯ In these trials, COPD subjects administered nebulized arformoterol demonstrated significant and sustained improvement in lung function over 12 weeks.
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Randomized Controlled Trial Multicenter Study
Spirometry, rapid FEV1 decline, and lung cancer among asbestos exposed heavy smokers.
We assessed whether spirometric measurements are associated with the development of accelerated FEV(1) decline and lung cancer among active and previous smokers with a wide range of lung function. Bivariate and multivariate analyses that adjusted for age, intervention arm, smoking status at enrollment and smoking history, years exposed to asbestos, and evidence of asbestosis were used to assess whether baseline FEV(1) and FEV(1)/FVC ratio were associated with accelerated FEV(1) decline and incident lung cancer. The 3,041 participants enrolled from 1985 to 1994 were followed through April 30, 2005. ⋯ Baseline FEV(1)/FVC ratio<0.7 was also significantly associated with an increased risk of developing lung cancer, even when baseline FEV(1) was >80%. Lung cancer risk among participants with baseline airflow obstruction and FEV(1)<60% was 4-fold higher than participants without baseline airflow obstruction and FEV(1)>80% (p<0.001), even among former smokers. These data indicate an FEV(1)/FVC<0.7 among smokers is significantly associated with faster airflow loss, and an increased risk for developing lung cancer, even among those individuals with a normal FEV(1).
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Randomized Controlled Trial Multicenter Study
Physiologic variables and functional status independently predict COPD hospitalizations and emergency department visits in patients with severe COPD.
Using clinical and claims records from the National Emphysema Treatment Trial, we sought to identify factors that accurately predicted COPD exacerbations. This prospective cohort study consisted of subjects with severe emphysema randomized to medical therapy. Exacerbations were defined as a hospitalization or emergency department visit for COPD. ⋯ In 610 participants, 26.6% had a COPD exacerbation over 1-year follow-up. In a model incorporating spirometry, PaO2, dyspnea, prior exacerbations and co-morbidity, a 5-point decrement in percent predicted FEV1 (OR 1.16, 95% CI 1.00-1.34) and a 5-point worsening in SOBQ (OR 1.08, 1.02-1.14) independently predicted exacerbations (AUC for full model 0.68). Combining physiologic variables, dyspnea, prior exacerbations and co-morbidity may be useful in identifying patients at high risk for COPD exacerbations.
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Multicenter Study
Decline in FEV1 in relation to incident chronic obstructive pulmonary disease in a cohort with respiratory symptoms.
Data on the relationship between decline in lung function and development of COPD are sparse. We assessed the decline in FEV1 during 10 years among subjects with respiratory symptoms by two different methods and evaluated risk factors for decline and its relation to incident Chronic Obstructive Pulmonary Disease, COPD. A cross-sectional postal questionnaire was in 1986 sent to 6610 subjects of three age strata. ⋯ Gender-specific analysis revealed that smoking was a stronger risk factor in women than in men, while higher age was a significant risk factor in men only. In conclusion, decline in FEV1 was associated with age, smoking, and chronic productive cough, but the risk factor pattern was gender-dependent. Among incident cases of COPD the decline was steeper and close to a quarter had a rapid decline.