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Joachim Müller-Quernheim,
Elliot S Barnathan,
Roland du Bois,
Robert P Baughman,
Rozsa Schlenker-Herceg,
Marjolein Drent,
Mani Kavuru,
Carlo Albera,
Susan Flavin, Marc A Judson,
Kim Hung Lo,
Martin Brutsche,
Ulrich Costabel,
Barry Oemar,
Gerald Davis,
James F Donohue
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ABSTRACT: Chronic obstructive pulmonary disease (COPD) is a serious global health burden. Comprehensive management of COPD includes both pharmacologic and non-pharmacologic interventions aimed at improving disease-related functional capacity, health-related quality of life, and survival. The primary medications used for treatment of COPD are inhaled bronchodilator drugs which are delivered directly to the patient's airways through a number of different mechanisms. Arformoterol, the (R,R) enantiomer of racemic formoterol, was the first long-acting beta agonist approved by the U.S. Food and Drug Administration (FDA) for nebulized delivery. We discuss the pharmacology, clinical efficacy, and safety of arformoterol, and provide recommendations for its use during longitudinal management of patients with COPD.
Therapeutic Advances in Respiratory Disease 11/2012;
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ABSTRACT: Chronic obstructive pulmonary disease (COPD) is a respiratory syndrome affecting more than 80 million people worldwide and is estimated to become the third-leading cause of death worldwide by 2030. A standard-of-care approach to COPD treatment is multifaceted, including pharmacological and non-pharmacological therapies, yet the optimum combination among many bronchodilator possibilities remains unclear. We discuss the evidence for effectiveness of combination bronchodilator and inhaled corticosteroid therapy in affecting the minimal clinically important difference for these agents in COPD. We propose an approach to the rational use of these combinations that favours the combination of long-acting β-adrenergic agents with long-acting anticholinergic agents in lieu of any other bronchodilators whenever possible. We suggest that, to better detect effects of disease modification in COPD, future studies of combination bronchodilator effectiveness should emphasize endpoints other than short-term change in post-bronchodilator forced expiratory volume in 1 second (FEV(1)).
Drugs 02/2012; 72(3):301-8. · 4.23 Impact Factor
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ABSTRACT: Relationships between improvements in lung function and other clinical outcomes in chronic obstructive pulmonary disease (COPD) are not documented extensively. We examined whether changes in trough forced expiratory volume in 1 second (FEV(1)) are correlated with changes in patient-reported outcomes.
Pooled data from three indacaterol studies (n = 3313) were analysed. Means and responder rates for outcomes including change from baseline in Transition Dyspnoea Index (TDI), St. George's Respiratory Questionnaire (SGRQ) scores (at 12, 26 and 52 weeks), and COPD exacerbation frequency (rate/year) were tabulated across categories of ΔFEV(1). Also, generalised linear modelling was performed adjusting for covariates such as baseline severity and inhaled corticosteroid use.
With increasing positive ΔFEV(1), TDI and ΔSGRQ improved at all timepoints, exacerbation rate over the study duration declined (P < 0.001). Individual-level correlations were 0.03-0.18, but cohort-level correlations were 0.79-0.95. At 26 weeks, a 100 ml increase in FEV(1) was associated with improved TDI (0.46 units), ΔSGRQ (1.3-1.9 points) and exacerbation rate (12% decrease). Overall, adjustments for baseline covariates had little impact on the relationship between ΔFEV(1) and outcomes.
These results suggest that larger improvements in FEV(1) are likely to be associated with larger patient-reported benefits across a range of clinical outcomes.
ClinicalTrials.gov NCT00393458, NCT00463567, and NCT00624286.
Respiratory research 12/2011; 12:161. · 3.36 Impact Factor
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ABSTRACT: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The diagnosis of COPD is based on spirometric evidence of airways obstruction following bronchodilator administration. Although it used to be commonly believed that patients with COPD have largely irreversible airflow obstruction, evidence now suggests that a considerable proportion of patients exhibit clinically significant bronchodilator reversibility. The complexity and inherent variability of a patient's acute response to a bronchodilator and the lack of a standardized procedure for assessing bronchodilator reversibility have led to significant confusion surrounding this concept. Although bronchodilator reversibility commonly is defined based on thresholds for improvement in FEV(1), lung volume-based measures of pulmonary function may be of particular importance in patients with severe COPD. The usefulness of acute reversibility to short-acting bronchodilators in predicting a patient's long-term response to bronchodilator maintenance therapy is also unclear, although most studies suggest that a lack of acute response to short-acting bronchodilators does not preclude a beneficial long-term response to maintenance bronchodilator treatment. This review outlines recent findings about the prevalence and usefulness of bronchodilator reversibility in patients with COPD based on the available literature and proposes areas of future research.
Chest 10/2011; 140(4):1055-63. · 5.25 Impact Factor
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ABSTRACT: Chronic obstructive pulmonary disease (COPD) has historically been considered a disease of older, white, male smokers, as illustrated in Frank Netter's classic images of the 'pink puffer' and 'blue bloater'. However, women may be more susceptible to COPD than men, and the disease course may be reflective of that increased susceptibility. From a review of epidemiological data of COPD, we found differences in the way men and women present with COPD symptoms, a bias in the way COPD symptoms are treated in men and women, and differences in susceptibility to airway obstruction based on age, sex, and smoking history. These data show that classic stereotypes of COPD - including male predominance - should be abandoned, and that there are not two but multiple COPD phenotypes, which are characterised by differences between women and men in susceptibility, symptoms, and disease progression. These differences impact on physician perception. Although further research into this concept is needed, the differences we found should prompt, in the short term, changes in the way (and in whom) COPD is evaluated, diagnosed, and treated; in the long term, these differences should prompt research into the prognosis of COPD based on sex differences.
Primary care respiratory journal: journal of the General Practice Airways Group 09/2011; 20(4):370-8.
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ABSTRACT: Although chronic obstructive pulmonary disease (COPD) is a major global health problem with a rising incidence and morbidity, few pharmacotherapeutic advances have been made over the past several decades. The challenges of development of such agents are multifactorial and include rudimentary understanding of the biological genesis of human disease, inadequate in-vitro and in-vivo models, unvalidated biomarkers, inefficient physiological and clinical endpoints, and variable regulatory review worldwide. Blockade of various inflammatory pathways and mediators is a reasonable therapeutic strategy to alter the natural history of COPD. Substantial heterogeneity is evident with respect to clinical presentation, physiology, imaging, response to therapy, decline in lung function, and survival. Numerous endpoints have been proposed for clinical studies in COPD, with new approaches under study. The novel strategy that seems most promising is the use of biomarkers. We hope that with these approaches novel pharmacotherapies will be developed in the near future.
The Lancet 09/2011; 378(9795):1027-37. · 38.28 Impact Factor
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Matthew L Mintz,
Barbara P Yawn,
David M Mannino, James F Donohue,
Nicola A Hanania,
Catherine A Grellet,
Alicia W Gilsenan,
Lori D McLeod,
Anand A Dalal,
Ibrahim H Raphiou,
Barbara A Prillaman,
Glenn D Crater,
Michael J Cicale,
Douglas W Mapel
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ABSTRACT: To estimate the prevalence of unidentified chronic obstructive pulmonary disease (COPD) and determine the screening accuracy of the Lung Function Questionnaire (LFQ).
Cigarette smokers who had a smoking history of 10 or more pack-years and were aged 30 years or older were recruited from 36 centers from February 18, 2009, to May 29, 2009. A total of 1575 patients completed a Web-based survey including the 5-item LFQ. Spirometry was performed on patients with an LFQ total score of 18 or less and on a subset scoring more than 18. The primary outcome was the proportion of patients at risk of airflow obstruction as measured by the LFQ (score, ≤ 18) in whom an airflow obstruction was confirmed by spirometry.
Of the patients who completed the LFQ, 849 (54%) had standardized spirometry data available. On the basis of LFQ and spirometry results, the estimated prevalence of possible COPD was 17.9% (95% confidence interval, 15.3%-20.6%). At a cut point of 18 or less, sensitivity, specificity, positive predictive value, and negative predictive value of the LFQ were 88%, 25%, 21%, and 90%, respectively. Approximately 1 in 5 patients (21%) aged 30 years or older and 1 in 4 (26%) aged 50 years or older scored 18 or less on the LFQ and had a ratio of forced expiratory volume in the first second of expiration to forced vital capacity less than 0.70.
On the basis of postbronchodilator spirometry results using weighted estimates, approximately 1 in 5 patients (21%) aged 30 years or older with a smoking history of 10 or more pack-years seen in a primary care setting is likely to have COPD. The LFQ could be a helpful COPD case-finding tool for clinicians to identify patients who need further evaluation.
clinicaltrials.gov Identifier: NCT01013948.
Mayo Clinic Proceedings 05/2011; 86(5):375-81. · 5.70 Impact Factor
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ABSTRACT: Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and mortality worldwide. Developments in the understanding of COPD have led to standard guidelines for diagnosis, treatment, and spirometry assessments, which have in turn influenced trial designs and inclusion criteria. Substantial clinical evidence has been gained from clinical trials and supports a positive approach to COPD management. However, there appear to be changing trends in recent trials. Large bronchodilator studies have reported lower improvements in trough forced expiratory volume in 1 second (FEV(1)) values versus placebo than were observed in earlier studies, while the rate of FEV(1) decline seems to be lower in more recent trials. In addition, recent evidence has called into question the usefulness of bronchodilator reversibility testing as a trial inclusion criterion. Baseline patient populations and use of concomitant medications have also changed over recent years due to increased treatment options. The impact of these many variables on clinical trial results is explored, with a particular focus on changes in inclusion criteria and patient baseline demographics.
International Journal of COPD 01/2011; 6:35-45.
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ABSTRACT: Pooled data were analyzed to evaluate the safety and tolerability of indacaterol, a once-daily inhaled long-acting β(2)-agonist for chronic obstructive pulmonary disease (COPD).
Data were pooled from clinical studies of 3-12 months' duration in patients with moderate-to-severe COPD receiving double-blind indacaterol 75 μg (n = 449), 150 μg (n = 2611), 300 μg (n = 1157), or 600 μg once daily (n = 547); formoterol 12 μg twice daily (n = 556); salmeterol 50 μg twice daily (n = 895); placebo (n = 2012); or tiotropium 18 μg once daily, given open label or blinded (n = 1214). Outcomes were adverse events, serious adverse events and deaths, plasma potassium, blood glucose, and QTc interval and vital signs.
The commonest adverse events with indacaterol were COPD worsening, nasopharyngitis, and headache; most cases were mild or moderate and incidence was generally similar to placebo and other active treatments. The risk of acute respiratory serious adverse events (leading to hospitalization, intubation, or death) was not significantly increased with any of the active treatments compared with placebo. COPD exacerbation rates (analyzed in the intent-to-treat population) were significantly reduced with all active treatments versus placebo. Hazard ratios versus placebo for major cardiovascular adverse events were < 1 for all indacaterol doses. Notable values for vital signs and measures of systemic β(2)-adrenoceptor activity were rare with indacaterol. The number of deaths adjusted per patient-year was lower with indacaterol (all doses combined) than with placebo (relative risk 0.21 [95% confidence interval 0.07-0.660], P = 0.008).
Indacaterol has a good profile of safety and tolerability that is appropriate for the maintenance treatment of patients with COPD.
International Journal of COPD 01/2011; 6:477-92.
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Paul W Jones,
Stephen I Rennard,
Alvar Agusti,
Pascal Chanez,
Helgo Magnussen,
Leonardo Fabbri, James F Donohue,
Eric D Bateman,
Nicholas J Gross,
Rosa Lamarca,
Cynthia Caracta,
Esther Garcia Gil
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ABSTRACT: The long-term efficacy and safety of aclidinium bromide, a novel, long-acting muscarinic antagonist, were investigated in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
In two double-blind, 52-week studies, ACCLAIM/COPD I (n=843) and II (n=804), patients were randomised to inhaled aclidinium 200 μg or placebo once-daily. Patients were required to have a post-bronchodilator forced expiratory volume in 1 second (FEV1)/forced vital capacity ratio of ≤70% and FEV1<80% of the predicted value. The primary endpoint was trough FEV1 at 12 and 28 weeks. Secondary endpoints were health status measured by St George's Respiratory Questionnaire (SGRQ) and time to first moderate or severe COPD exacerbation.
At 12 and 28 weeks, aclidinium improved trough FEV1 versus placebo in ACCLAIM/COPD I (by 61 and 67 mL; both p<0.001) and ACCLAIM/COPD II (by 63 and 59 mL; both p<0.001). More patients had a SGRQ improvement≥4 units at 52 weeks with aclidinium versus placebo in ACCLAIM/COPD I (48.1% versus 39.5%; p=0.025) and ACCLAIM/COPD II (39.0% versus 32.8%; p=0.074). The time to first exacerbation was significantly delayed by aclidinium in ACCLAIM/COPD II (hazard ratio [HR] 0.7; 95% confidence interval [CI] 0.55 to 0.92; p=0.01), but not ACCLAIM/COPD I (HR 1.0; 95% CI 0.72 to 1.33; p=0.9). Adverse events were minor in both studies.
Aclidinium is effective and well tolerated in patients with moderate to severe COPD.
ClinicalTrials.gov: NCT00363896 (ACCLAIM/COPD I) and NCT00358436 (ACCLAIM/COPD II).
Respiratory research 01/2011; 12:55. · 3.36 Impact Factor
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ABSTRACT: Beta-2 adrenergic agonists are sympathomimetic agents that stimulate bronchodilation by activation of adenyl cyclase to produce cyclic 3'5' adenosine monophosphate (AMP). Short-acting beta-agonists (SABAs) have a 3- to 6-hour duration of action, and the duration of action of long-acting beta-agonists (LABAs) exceeds 12 hours. Because of their rapid onset of action, SABAs are effective for rescue from symptoms of chronic obstructive pulmonary disease (COPD). LABAs-salmeterol and formoterol-have been shown to significantly improve lung function, health status, and symptom reduction, compared with ipratropium. Despite safety concerns over the use of LABAs as monotherapy in asthma the use of these medications in COPD has generally been described as safe. Novel bronchodilators for COPD in late-stage development include the beta-agonists indacterol and carmoterol. Parasympathetic activity in the large and medium-size airways is mediated through the muscarinic receptors and results in airway smooth-muscle contraction, mucus secretion, and possibly increased ciliary activity. Although short-acting ipratropium has been used as monotherapy or in combination with albuterol the use of long-acting antimuscarinics is superior in improving health outcomes. The use of tiotropium results in improved health status, dyspnea, and exercise capacity, and reduced hyperinflation and COPD exacerbation rate in patients with moderate to severe COPD. Analysis of prospective clinical trial data shows a mortality reduction in subjects treated with tiotropium, despite retrospective review of insurance claims that show an enhanced mortality. Theophylline is a nonselective phosphodiesterase inhibitor that acts as both a weak bronchodilator and a respiratory stimulant. Novel approaches include using the inhalation route to reduce side effects and combination with inhaled corticosteroids (ICS). However, because of its potential adverse effects and narrow therapeutic index, it should only be used when symptoms persist despite optimal bronchodilator therapy. Current guidelines highlight that for COPD patients uncontrolled by bronchodilator monotherapy, combination therapy is recommended. These include LABA/ICS and LAMA/LABA combinations. Bronchodilators and their combination with ICS are central to the management of COPD. The choice of agents is based primarily on disease stage, individual response, cost, side effect profile, and availability.
Seminars in Respiratory and Critical Care Medicine 06/2010; 31(3):321-33. · 2.43 Impact Factor
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James F Donohue,
Charles Fogarty,
Jan Lötvall,
Donald A Mahler,
Heinrich Worth,
Arzu Yorgancioglu,
Amir Iqbal,
James Swales,
Roger Owen,
Mark Higgins,
Benjamin Kramer
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ABSTRACT: Indacaterol is the first once-daily, long-acting inhaled beta(2)-agonist bronchodilator studied in patients with chronic obstructive pulmonary disease (COPD).
To demonstrate greater efficacy of indacaterol versus placebo on FEV(1) at 24 hours post dose (trough) after 12 weeks, to compare efficacy with placebo and tiotropium, and to evaluate safety and tolerability over 26 weeks.
Patients with moderate-to-severe COPD were randomized to double-blind indacaterol 150 or 300 microg or placebo, or open-label tiotropium 18 microg, all once daily, for 26 weeks. The primary efficacy outcome was trough FEV(1) at 12 weeks. Additional analyses (not adjusted for multiplicity) included transition dyspnea index (TDI), health status (St George's Respiratory Questionnaire [SGRQ]), and exacerbations. Serum potassium, blood glucose, and QTc interval were measured.
A total of 1,683 patients (age, 63.3 yr; post-bronchodilator FEV(1), 56% predicted; FEV(1)/FVC, 0.53) were randomized to the four treatment arms. Trough FEV(1) at Week 12 increased versus placebo by 180 ml with both indacaterol doses and by 140 ml with tiotropium (all P < 0.001 vs. placebo). At Week 26, for indacaterol 150/300 microg, respectively, versus placebo, TDI increased (1.00/1.18, P < 0.001) and SGRQ total score decreased (-3.3/-2.4, P < 0.01); corresponding results with tiotropium were 0.87 (P < 0.001) for TDI and (-1.0, P = not significant) for SGRQ total score. The incidence of adverse events, low serum potassium, high blood glucose, and prolonged QTc interval was similar across treatments.
Indacaterol was an effective once-daily bronchodilator and was at least as effective as tiotropium in improving clinical outcomes for patients with COPD. Clinical trial registered with clinicaltrials.gov (NCT 00463567).
American Journal of Respiratory and Critical Care Medicine 06/2010; 182(2):155-62. · 11.08 Impact Factor
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ABSTRACT: The US Preventive Services Task Force recommends against spirometry in the absence of symptoms. However, as much as 50% of COPD cases in the United States remain undiagnosed.
Report of symptoms, smoking history, and spirometric data were collected from subjects screened for a work-related medical evaluation (N = 3,955). Prevalence of airflow obstruction and respiratory symptoms were assessed. Sensitivity, specificity, positive and negative predictive values, and relative risks of predicting symptoms and smoking history for COPD were calculated.
Forty-four percent of smokers in our sample had airways obstruction (AO). Of these, 36% reported a diagnosis of or treatment for COPD. Odds ratio (95% CI) for AO with smoking (> or = 20 pack-years) was 3.73 (3.12- 4.45), 1.98 (1.73-2.27) for cough, 1.79 (1.55-2.08) for dyspnea, 1.95 (1.70-2.34) for sputum, and 2.59 (2.26-2.97) for wheeze. Respiratory symptoms were reported by 92% of smokers with AO, 86% smokers with restriction, 76% smokers with normal spirometry, and 73% of nonsmokers. Sensitivity (92% vs 90%), specificity (19% vs 22%), positive (47% vs 40%) and negative (75% vs 80%) predictive values for the presence of one or more symptoms were similar between smokers and all subjects.
COPD is underdiagnosed in the United States. Symptoms are frequent in subjects with AO and increase their risk for COPD, but add little beyond age and smoking history to the predictive value of spirometry. In view of the high prevalence of symptoms and their poor predictive value, a simpler and more effective approach would be to screen older smokers.
Chest 04/2010; 137(6):1345-53. · 5.25 Impact Factor
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Nicola A Hanania,
David M Mannino,
Barbara P Yawn,
Douglas W Mapel,
Fernando J Martinez, James F Donohue,
Mark Kosinski,
Regina Rendas-Baum,
Matthew Mintz,
Steven Samuels,
Priti Jhingran,
Anand A Dalal
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ABSTRACT: The Lung Function Questionnaire (LFQ) is being developed as a case finding tool to identify patients who are appropriate for spirometry testing to confirm the diagnosis of chronic obstructive pulmonary disease (COPD). The cross-sectional study reported herein was conducted to validate the LFQ, to identify item-response scales associated with the best accuracy, and to determine the impact on accuracy of the addition of another item on activity limitations (AL). Patients >or= 40 years old seen at 2 primary care offices completed the LFQ, a demographic questionnaire followed by spirometry. Of the 837 evaluable patients, 18.6% had airflow obstruction (forced expiratory volume in 1 s/forced vital capacity [FEV(1)/FVC] < 0.70). The 5 items (age, wheeze, dyspnea, smoking, and cough) previously identified in initial LFQ development predicted airflow obstruction and showed good evidence of screening accuracy. Screening accuracy was significantly better with 5-point ordinal item-response scales (78%) than binary (yes/no) item-response scales (74%)(p < 0.05). Screening accuracy was good regardless of whether airflow obstruction was defined as FEV(1)/FVC < 0.70 or FEV(1)/FVC < 0.70 and FEV(1) < 80% of predicted. Based on <or=18 was selected to suggest presence of airflow obstruction with area under the receiver operating characteristic curve 0.652; sensitivity 82.6%; specificity 47.8%; 54.3% correctly classified. While the specificity of LFQ is low, its high sensitivity suggests that it can serve to identify patients who should be further assessed using spirometry. Our results confirm the screening accuracy of the LFQ, a simple and effective tool to facilitate early recognition and diagnosis of COPD.
Respiratory medicine 03/2010; 104(8):1160-70. · 2.33 Impact Factor
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ABSTRACT: 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. Pulmonary function improved for all treatment groups and was maintained throughout the study. Mean change from baseline at 6-months for ARF 15, ARF 25 and FORM in peak FEV(1) was 0.30L, and 0.34L, and 0.26L, respectively, in 24-hour trough FEV(1) was, 0.10L, 0.14L, and 0.09L, and in inspiratory capacity was, 0.20L, 0.37L, and 0.23L. 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.
COPD Journal of Chronic Obstructive Pulmonary Disease 02/2010; 7(1):17-31. · 1.79 Impact Factor
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ABSTRACT: Comparisons of health-related quality of life (HRQOL) between persons with chronic obstructive pulmonary disease (COPD) and adults in the general population are not well described.
To examine associations between COPD and four measures of HRQOL in a population-based sample. PATIENTS #ENTITYSTARTX00026;
These relationships were examined using data from 13,887 adults aged >18 years who participated in the 2007 Behavioral Risk Factor Surveillance System (BRFSS) conducted in North Carolina (NC). Logistic regression was used to obtain adjusted relative odds (aOR).
The age-adjusted prevalence of COPD among NC adults was 5.4% (standard error 0.27). Nearly half of adults with COPD reported fair/poor health compared with 15% of those without the condition (age-aOR, 5.5; 95% confidence interval [ CI] , 4.4 to 6.8). On average, adults with COPD reported twice as many unhealthy days (physical/mental) as those without the condition. The age-adjusted prevalence of >14 unhealthy days during the prior 30 days was 45% for adults with COPD and 17% for those without. The aOR of >14 unhealthy days was 1.7 (95% CI, 1.4 to 2.2) times greater among adults with COPD compared with those without.
These results suggest COPD is independently associated with lower levels of HRQOL and reinforce the importance of preventing COPD and its complications through health education messages stressing efforts to reduce total personal exposure to tobacco smoke, occupational dusts and chemicals, and other indoor and outdoor air pollutants linked to COPD and early disease recognition. Our findings represent one of the few statewide efforts in the US and provide guidance for disease management and policy decision making.
North American journal of medical sciences. 02/2010; 2(2):60-5.
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ABSTRACT: A nebulized formulation of formoterol, Perforomist, 20 microg/2 ml, has been available since 2007 for the maintenance treatment of chronic obstructive pulmonary disease (COPD). We review the safety and efficacy data obtained during its development. In a dose-finding study, formoterol inhalation solution (FFIS) was similar to the formoterol originator, Foradil 12 microg DPI (FA) in patients with COPD. In a 12-week efficacy study, FFIS manifested a rapid onset of action and FEV(1) peak, AUC(0-12), and trough levels similar to FA. No loss of efficacy, tachyphylaxis, was observed over 12 weeks of regular administration. In placebo-controlled studies in COPD patients receiving maintenance tiotropium, the addition of FFIS significantly augmented bronchodilation over the 6-week treatment duration, signifying that nebulized formoterol can further improve lung function in patients who are receiving tiotropium without an observed increase in adverse reactions. The safety profile of FFIS during 12-week and 1-year studies revealed adverse events that were similar to those of placebo and FA. Cardiac rhythm studies, including frequent ECGs and Holter monitoring, did not indicate any increase in rate or rhythm disturbances greater than placebo or FA. We conclude that maintenance use of Perforomist is appropriate for patients with COPD who require or prefer a nebulizer for management of their disease.
International Journal of COPD 01/2010; 5:223-32.
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Barbara P Yawn,
Douglas W Mapel,
David M Mannino,
Fernando J Martinez, James F Donohue,
Nicola A Hanania,
Mark Kosinski,
Regina Rendas-Baum,
Matthew Mintz,
Steven Samuels,
Anand A Dalal
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ABSTRACT: To describe the item-selection and item-reduction for the Lung Function Questionnaire (LFQ), being developed to help clinicians identify patients appropriate for diagnostic evaluation for chronic obstructive pulmonary disease (COPD) using spirometry.
Item selection and reduction were based on information from 387 > or =40-year-old respondents to the third National Health and Nutrition Examination Survey who had self-reported chronic bronchitis. Item reduction involved stepwise logistic regression. The accuracy of the final subset of items for identifying individuals with airflow obstruction (forced expiratory volume in one second/forced vital capacity <0.70) versus those without it was assessed with receiver operating characteristic analysis. Content and face validity were assessed using focus groups of primary care physicians (n = 16) and interviews with COPD patients (n = 16).
The model with all five items (age; smoking history; the presence of wheeze, dyspnea, and phlegm) compared with models with combinations of fewer items had the highest classification accuracy (area under the curve [AUC] = 0.720) with sensitivity and specificity of 73.2% and 58.2%, respectively. The presence of three or more factors yielded the highest AUC, a result suggesting that three or more affirmative answers is the most appropriate criterion indicating presence of airflow obstruction.
The five-item LFQ retained sufficient accuracy, sensitivity, and specificity in identifying individuals with COPD for further validation testing.
International Journal of COPD 01/2010; 5:1-10.
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ABSTRACT: Formoterol fumarate is a long-acting beta2-agonist that is an effective bronchodilator for the maintenance management of patients with chronic obstructive pulmonary disease. The safety profile of the newly developed nebulized formoterol was evaluated over a twelve-month period in an open-label, active-control study. After completing a twelve-week double-blind double-dummy period, 569 subjects with chronic obstructive pulmonary disease entered an open-label extension study and received twice-daily 20 microg formoterol fumarate inhalation solution for nebulization (FFIS) or 12 microg formoterol fumarate dry powder inhalation (FA) for 52 weeks. Most of the FFIS-treated subjects (86%) completed at least six months of open-label treatment with over 90% compliance, comparable to the FA group (88%). RESULTS: of safety monitoring for adverse events, laboratory values, and cardiac changes were similar between treatment groups. Three hundred forty (73%) of FFIS-treated subjects and 83 (78%) of FA-treated subjects experienced an adverse event over the course of the study, the majority of which were mild to moderate and considered unrelated to treatment. COPD exacerbation occurred in 15.8% of FFIS-treated and 17.9% of FA-treated subjects. Deaths, serious adverse events, and discontinuations for adverse events occurred in 1.3, 16.2, and 5.4% of the nebulized group versus 1.9, 17.9, and 7.5% of the inhaled group, respectively. There were no clinically important changes from baseline in laboratory tests, including serum potassium and glucose, or vital signs and no treatment-related increases in cardiac arrhythmias, heart rate, or QTc prolongation. We conclude that nebulized formoterol fumarate twice daily is well tolerated over long-term treatment in moderate-to-severe COPD subjects and has a similar safety profile to the DPI formulation.
Therapeutic Advances in Respiratory Disease 09/2008; 2(4):199-208.
