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James M Roach - One of the best experts on this subject based on the ideXlab platform.

  • comparison of Levalbuterol and racemic albuterol in hospitalized patients with acute asthma or copd a 2 week multicenter randomized open label study
    Clinical Therapeutics, 2008
    Co-Authors: James F Donohue, Kendyl Schaefer, William T Andrews, Raymond Claus, Nicola A Hanania, Ronald L Ciubotaru, David J Pasta, James M Roach
    Abstract:

    Abstract Background: The National Heart, Lung, and Blood Institute guideline recommends that dosing racemic albuterol be administered every 1 to 4 hours for treating patients with asthma or chronic obstructive pulmonary disease (COPD) in the hospital. Previously published preliminary and retrospective studies suggested that Levalbuterol can be administered every 8 hours for the treatment of bronchoconstriction in hospitalized patients. However, it is unclear how the different dosing regimens affect the total number of nebulizations (scheduled plus as-needed treatments) and the costs of treatment of bronchoconstriction in a hospital setting. Moreover, it is not clear how the different dosing regimens affect symptom outcomes and health status in hospitalized patients with asthma or COPD. Objective: The aim of this study was to evaluate these issues in hospitalized patients with acute asthma or COPD. Methods: In this prospective, multicenter, randomized, open-label study, hospitalized patients aged ≥18 years were randomly assigned to receive 14-day treatment with Levalbuterol 1.25 mg q6-8h or racemic albuterol 2.5 mg q1-4h, administered per routine hospital practice at each institution. The primary efficacy end point was total number of nebulizations during hospitalization. Pulmonary function, symptom evaluation (subject general well-being score [SGWB], disease symptom assessment [DSA], and β-mediated adverse effect scores), hospital costs (excluding medication costs) and hospital length of stay (LOS) were also evaluated. Results: In the intent-to-ttreat population (n = 479; Levalbuterol, 241;racemic albuterol, 238), the mean (SE) age was 55.3 (16.9) years, the majority of patients were white (57.8%), and the mean (SE) weight was 80.9 (24.5) kg. Demographic characteristics were similar between the 2 treatment groups, except that there were more females with COPD in the Levalbuterol treatment group (63.88%) compared with the racemic albuterol treatment group (45.5%) ( P = 0.005). Patients treated with Levalbuterol required significantly fewer median total nebulizations (10 vs 12; P = 0.031) and scheduled nebulizations (9 vs 11; P = 0.009) compared with those in the racemic albuterol group. The 2 treatment groups required 0 rescue nebulizations. Mean (SD) forced expiratory volume in 1 second improved from baseline with both Levalbuterol and racemic albuterol (0.06 [0.43] and 0.10 [0.37] L, respectively); these improvements were maintained throughout the hospital stay (0.11 [0.48] and 0.16 [0.52] L). DSA and SGWB scores improved significantly from baseline in both treatment groups, and β-mediated adverse effects mean scores were significantly greater with Levalbuterol versus racemic albuterol ( P Conclusions: In these hospitalized patients with acute asthma or COPD treated with Levalbuterol every 6 to 8 hours or racemic albuterol every 1 to 4 hours, significantly fewer total nebulizations were required with Levalbuterol, without an increased need for rescue nebulizations during 14 days of hospitalization. Both treatments were associated with improvements from baseline in symptoms and health status. The costs of treating bronchoconstriction in hospitalized patients were similar between the Levalbuterol and racemic albuterol groups.

  • Evaluation of the safety and efficacy of Levalbuterol in 2-5-year-old patients with asthma.
    Pediatric Pulmonology, 2005
    Co-Authors: David P Skoner, Merdad V Parsey, James M Roach, Leon S. Greos, Rudolf A Baumgartner
    Abstract:

    The purpose of this study was to evaluate the safety and efficacy of single-isomer (R)-albuterol (Levalbuterol, LEV) in children aged 2–5 years. Children aged 2–5 years (n = 211) participated in this multicenter, randomized, double-blind study of 21 days of t.i.d. LEV (0.31 mg or 0.63 mg without regard to weight), racemic albuterol (RAC, 1.25 mg for children

  • evaluation of the safety and efficacy of Levalbuterol in 2 5 year old patients with asthma
    Pediatric Pulmonology, 2005
    Co-Authors: David P Skoner, Merdad V Parsey, James M Roach, Leon S. Greos, Rudolf A Baumgartner
    Abstract:

    The purpose of this study was to evaluate the safety and efficacy of single-isomer (R)-albuterol (Levalbuterol, LEV) in children aged 2–5 years. Children aged 2–5 years (n = 211) participated in this multicenter, randomized, double-blind study of 21 days of t.i.d. LEV (0.31 mg or 0.63 mg without regard to weight), racemic albuterol (RAC, 1.25 mg for children <33 pounds (lb); 2.5 mg for children ≥33 lb), or placebo (PBO). Endpoints included adverse-event (AE) reporting, safety parameters, peak expiratory flow (PEF), the Pediatric Asthma Questionnaire© (PAQ), and the Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ). Baseline disease severity was generally mild in all groups, as defined by PAQ scores that ranged from 6.3–7.3 on a scale of 0–27 and 1.5 days/week of uncontrolled asthma. After treatment, the PAQ decreased in all groups (P = NS). In the subset of subjects able to perform PEF (51.7%), all active treatments improved in-clinic PEF after the first dose (mean ± SD: PBO, 1.4 ± 20.8; LEV 0.31 mg, 12.4 ± 12; LEV 0.63 mg, 16.7 ± 15.4; RAC, 18.0 ± 16.5 l/min; P < 0.01). PACQLQ measurements improved more than the minimally important difference only in the LEV-treated groups, and were significant in children <33 lb (P < 0.05). Asthma exacerbations occurred primarily in children ≥33 lb, and one serious asthma exacerbation occurred in the 2.5-mg RAC group. RAC and LEV 0.63 mg, but not LEV 0.31 mg or placebo, led to significant increases in ventricular heart rate. In this study of Levalbuterol in children aged 2–5 years with asthma, LEV was generally well-tolerated, and in children able to perform PEF, led to significant bronchodilation compared with placebo. Pediatr Pulmonol. © 2005 Wiley-Liss, Inc.

  • pairwise comparison of Levalbuterol versus racemic albuterol in the treatment of moderate to severe asthma
    Allergy and Asthma Proceedings, 2004
    Co-Authors: W W Pleskow, Kendyl Schaefer, H S Nelson, Raymond Claus, James M Roach
    Abstract:

    The object of this study is a post hoc pairwise comparison of Levalbuterol versus racemic albuterol for asthma in a multicenter, double-blind, randomized, placebo-controlled clinical trial. The participants are patients ≥12 years of age (n = 362) with FEV 1 45-70% of predicted. The patients received nebulized Levalbuterol (0.63 or 1.25 mg), racemic albuterol (1.25 or 2.5 mg), or placebo t.i.d. for 4 weeks. The primary endpoints, published in Nelson HS, Bensch G, Pleskow WW, et al. Improved bronchodilation with Levalbuterol compared with racemic albuterol in patients with asthma. J Allergy Clin Immunol 102:943-952, 1998, included comparisons of active treatments with placebo and of the combined Levalbuterol with the combined racemic albuterol groups for pulmonary function and rescue medication use. After the first dose, Levalbuterol 1.25 mg produced a significantly greater increase in the mean peak change in FEV 1 compared with both doses of racemic albuterol (p < 0.03) in all patients and in those with more severe asthma. Levalbuterol 1.25 mg also produced a significantly greater (p < 0.05) mean area under the curve (AUC) of the FEV 1 versus time plot (AUC FEV 1 ) compared with all other treatments after the first dose in all patients and in the subset with mare severe disease, illustrating better overall improvement in FEV 1 . Active treatment groups demonstrated significant improvements compared with the placebo group (p < 0.05), except for A UC FEV 1 in the racemic albuterol 1.25-mg group at week 4. Levalbuterol in the absence of the (S)-isomer provided greater bronchodilation ,than the same quantity of (R)-albuterol delivered as the racemate. These data suggest that (S)-albuterol may compromise the efficacy of (R)-albuterol.

Rudolf A Baumgartner - One of the best experts on this subject based on the ideXlab platform.

  • a cumulative dose study of Levalbuterol and racemic albuterol administered by hydrofluoroalkane 134a metered dose inhaler in asthmatic subjects
    The Journal of Allergy and Clinical Immunology, 2008
    Co-Authors: Kenneth Tripp, Elizabeth B Goodwin, W W Pleskow, Rudolf A Baumgartner, William K Mcvicar, Parameswaran Nair, Jonathan Corren, John P Hanrahan
    Abstract:

    Background The short-acting β 2 -agonists Levalbuterol and racemic albuterol are available for administration through a hydrofluoroalkane-134a (HFA) metered-dose inhaler (MDI). Objective This study compared the short-term safety and efficacy of cumulative doses of Levalbuterol HFA MDI and racemic albuterol HFA MDI in asthmatic subjects. Methods This was a randomized, modified-blind, active-controlled, multicenter, 2-way crossover study. Subjects (n = 49) were randomized to 16 cumulative doses (1×, 2×, 4×, 8×, and 16×) of Levalbuterol (45 μg per dose) or racemic albuterol (90 μg per dose) administered over a 2-hour period. After a 7-day washout period, subjects were crossed over to the other treatment. After each dose, safety outcomes and pulmonary function were assessed. Results Heart rate and (R)-albuterol exposure increased for both racemic albuterol HFA and Levalbuterol HFA. For cumulative doses of 8× or greater, racemic albuterol HFA treatment had greater increases in mean heart rate than Levalbuterol HFA (least-squares mean [± SD] difference at the 8× dose was 2.8 beats/min [95% CI, 0.3-5.3] and at the 16× dose was 3.5 beats/min [95% CI, 0.6-6.4]). (R)-albuterol plasma levels ranged from 10% to 18% higher after racemic albuterol HFA MDI dosing versus after Levalbuterol HFA MDI. FEV 1 improvements were similar for both treatments. The relative potencies of the 2 therapies, based on FEV 1 , were similar (ratio, 1.1 [90% CI, 0.9-1.2]; Finney method). Conclusion In this study single-day cumulative dosing of asthmatic subjects with Levalbuterol HFA MDI or racemic albuterol HFA MDI resulted in similar improvements in FEV 1 and tolerability. Plasma (R)-albuterol levels and mean heart rate were less with Levalbuterol HFA MDI.

  • long term safety study of Levalbuterol administered via metered dose inhaler in patients with asthma
    Annals of Allergy Asthma & Immunology, 2007
    Co-Authors: Daniel L Hamilos, Kenneth Tripp, Merdad V Parsey, Rudolf A Baumgartner, Anthony Durzo, Robin J Levy, Michael Marcus, William K Mcvicar
    Abstract:

    Background Previous studies have raised concerns regarding the safety of regular use of β 2 -agonists for treating asthma. Few studies have explored the safety of at least 1 year of use of racemic albuterol, and none have examined long-term dosing of Levalbuterol. Objective To examine the long-term safety of Levalbuterol hydrofluoroalkane (HFA) vs racemic albuterol HFA administered via metered-dose inhaler (MDI) in patients with stable asthma. Methods Patients with mild to moderate asthma (mean forced expiratory volume in 1 second [FEV 1 ], 68.3% of predicted) 12 years or older participated in a multicenter, parallel-group, open-label study. Patients were randomized to Levalbuterol HFA MDI (90 μg; 2 actuations of 45 μg; n=496) or racemic albuterol HFA MDI (180 μg; 2 actuations of 90 μg; n=250) for 52 weeks of 4 times daily dosing. The primary end point was the incidence of postrandomization adverse events. Asthma exacerbations and pulmonary parameters were also assessed. Results The overall incidence of adverse events was similar for Levalbuterol (72.0%) and racemic albuterol (76.8%). Rates of β-mediated adverse events, serious adverse events, and discontinuations because of adverse events were low ( 1 improved after dosing and was stable for both groups. Conclusion In this trial, up to 52 weeks of regular use of Levalbuterol HFA MDI or racemic albuterol HFA MDI was well tolerated, and no deterioration of lung function was detected during the study period.

  • Population pharmacokinetics of (R)-albuterol and (S)-albuterol in pediatric patients aged 4-11 years with asthma.
    Pulmonary Pharmacology & Therapeutics, 2006
    Co-Authors: Gary Maier, Christopher Rubino, Thaddeus Grasela, Rudolf A Baumgartner
    Abstract:

    Abstract Objective To characterize the population pharmacokinetics (PK) of (R)- and (S)-albuterol in pediatric asthmatics using a model that supports a sparse blood sampling strategy. Methods The data for this analysis were collected from patients enrolled in a randomized, double-blind, multicenter, placebo- and active-controlled study evaluating the safety and efficacy of Levalbuterol in asthmatic children aged 4–11 years. Patients received either Levalbuterol 0.31 mg, Levalbuterol 0.63 mg, racemic albuterol 1.25 mg, or racemic albuterol 2.5 mg via nebulizer. Separate population pharmacokinetic models were developed for (R)- and (S)-albuterol using the NOMNEM ® computer program. Covariate models were developed to identify significant predictors of inter-patient variability. Results A total of 995 samples and 262 patients were used for the (R)-albuterol population PK model while a total of 496 samples and 128 patients were used for the (S)-albuterol population PK model. The apparent clearance of (R)-albuterol was much more rapid than that of (S)-albuterol (approximately four-fold higher), and the apparent volume of distribution was much larger for (R)-albuterol (in part due to pre-systemic metabolism) than for (S)-albuterol (approximately four-fold higher). Conclusions In this study of pediatric patients, the models were able to demonstrate using two to four samples per patient that the apparent clearance and volume of distribution of (R)-albuterol were several fold higher than that of (S)-albuterol. The pharmacokinetics of (R)-albuterol were similar after administration of Levalbuterol or racemic albuterol and were linear over the examined dose range (0.31–0.63 mg nebulized dose). The presence of (S)-albuterol did not significantly alter the pharmacokinetics of (R)-albuterol, suggesting that effects of (S)-albuterol may be due to the intrinsic pharmacology of this isomer.

  • evaluation of Levalbuterol metered dose inhaler in pediatric patients with asthma a double blind randomized placebo and active controlled trial
    Current Medical Research and Opinion, 2006
    Co-Authors: William E Berger, Henry Milgrom, David P Skoner, Kenneth Tripp, Merdad V Parsey, Rudolf A Baumgartner
    Abstract:

    ABSTRACTObjective: To evaluate the efficacy and safety of Levalbuterol metered dose inhaler (MDI) in children aged 4-11 years (n = 173).Research design and methods: Multicenter, randomized, double-blind 28‐day study of QID Levalbuterol 90 µg, racemic albuterol 180 µg, and placebo (2:1:1 ratio). Serial spirometry was performed on Days 0, 14, and 28. The primary endpoint was the double-blind average peak percent (%) change in FEV1 from visit pre-dose; the primary comparison was with placebo. Secondary endpoints included the area under the FEV1 percent change from pre-dose curve and peak % predicted FEV1. Safety endpoints included adverse events, laboratory tests, rescue medication use, and electrocardiograms.Results: Levalbuterol significantly improved the least square mean peak percent change in FEV1 compared with placebo (Levalbuterol 25.6% ± 1.3% [p < 0.001]; racemic albuterol 21.8% ± 1.8% [p = ns]; placebo 16.8% ± 1.9%). Results for Levalbuterol were similar for the other spirometry endpoints ( p < 0.05...

  • evaluation of the efficacy and safety of Levalbuterol in subjects with copd
    COPD: Journal of Chronic Obstructive Pulmonary Disease, 2006
    Co-Authors: James F Donohue, Kendyl Schaefer, Merdad V Parsey, Raymond Claus, Charles Andrews, Tony Durzo, Satyendra Sharma, Rudolf A Baumgartner
    Abstract:

    The efficacy and safety of nebulized Levalbuterol in adults with chronic obstructive pulmonary disease (COPD) was evaluated in this multicenter, randomized, double-blind, parallel design study. Randomized subjects (n = 209) received Levalbuterol (LEV) 0.63 mg or 1.25 mg, racemic albuterol (RAC) 2.5 mg, or placebo (PBO) TID for 6 weeks. Serial spirometry was completed in-clinic after study drug alone (weeks 0, 2, and 6) or in combination with ipratropium bromide 0.5 mg (week 4). The primary endpoint was the averaged FEV1 AUC(0–8 hrs) over weeks 0, 2 and 6 compared with placebo. Other endpoints included rescue medication use, safety parameters, COPD exacerbations, and global evaluations. All active treatments demonstrated improvements in the percent change in FEV1 AUC(0–8 hrs) over the double-blind period and at each visit vs PBO (p < 0.05). Rescue medication use vs. baseline (doses/day) changed over time: PBO +0.38 ± 3.3; LEV 0.63 mg +0.07 ± 3.3; LEV 1.25 mg −0.84 ± 3.8 (p = 0.02 vs. RAC); RAC +0.97 ± 2.5....

James F Donohue - One of the best experts on this subject based on the ideXlab platform.

  • Comparison of Levalbuterol and racemic albuterol in hospitalized patients with acute asthma or COPD: a 2-week, multicenter, randomized, open-label study.
    Clinical therapeutics, 2020
    Co-Authors: James F Donohue, Kendyl Schaefer, William T Andrews, Raymond Claus, Nicola A Hanania, Ronald L Ciubotaru, David J Pasta, James Roach
    Abstract:

    The National Heart, Lung, and Blood Institute guideline recommends that dosing racemic albuterol be administered every 1 to 4 hours for treating patients with asthma or chronic obstructive pulmonary disease (COPD) in the hospital. Previously published preliminary and retrospective studies suggested that Levalbuterol can be administered every 8 hours for the treatment of bronchoconstriction in hospitalized patients. However, it is unclear how the different dosing regimens affect the total number of nebulizations (scheduled plus as-needed treatments) and the costs of treatment of bronchoconstriction in a hospital setting. Moreover, it is not clear how the different dosing regimens affect symptom outcomes and health status in hospitalized patients with asthma or COPD. The aim of this study was to evaluate these issues in hospitalized patients with acute asthma or COPD. In this prospective, multicenter, randomized, open-label study, hospitalized patients aged > or = 18 years were randomly assigned to receive 14-day treatment with Levalbuterol 1.25 mg q6-8h or racemic albuterol 2.5 mg q1-4h, administered per routine hospital practice at each institution. The primary efficacy end point was total number of nebulizations during hospitalization. Pulmonary function, symptom evaluation (subject general well-being score [SGWB], disease symptom assessment [DSA], and beta-mediated adverse effect scores), hospital costs (excluding medication costs) and hospital length of stay (LOS) were also evaluated. In the intent-to-treat population (n = 479; Levalbuterol, 241;racemic albuterol, 238), the mean (SE) age was 55.3 (16.9) years, the majority of patients were white (57.8%), and the mean (SE) weight was 80.9 (24.5) kg. Demographic characteristics were similar between the 2 treatment groups, except that there were more females with COPD in the Levalbuterol treatment group (63.88%) compared with the racemic albuterol treatment group (45.5%) (P = 0.005). Patients treated with Levalbuterol required significantly fewer median total nebulizations (10 vs 12; P = 0.031) and scheduled nebulizations (9 vs 11; P = 0.009) compared with those in the racemic albuterol group. The 2 treatment groups required 0 rescue nebulizations. Mean (SD) forced expiratory volume in 1 second improved from baseline with both Levalbuterol and racemic albuterol (0.06 [0.43] and 0.10 [0.37] L, respectively); these improvements were maintained throughout the hospital stay (0.11 [0.48] and 0.16 [0.52] L). DSA and SGWB scores improved significantly from baseline in both treatment groups, and beta-mediated adverse effects mean scores were significantly greater with Levalbuterol versus racemic albuterol (P < 0.001). In the Levalbuterol and racemic albuterol treatment groups, hospital LOS (70.6 and 65.7 hours, respectively), time to discharge (66.0 and 62.8 hours), and total hospital costs (least squares mean [SE], US $4869.30 [$343.58] and $4899.41 [$343.20]) were similar. In these hospitalized patients with acute asthma or COPD treated with Levalbuterol every 6 to 8 hours or racemic albuterol every 1 to 4 hours, significantly fewer total nebulizations were required with Levalbuterol, without an increased need for rescue nebulizations during 14 days of hospitalization. Both treatments were associated with improvements from baseline in symptoms and health status. The costs of treating bronchoconstriction in hospitalized patients were similar between the Levalbuterol and racemic albuterol groups.

  • effects of arformoterol twice daily tiotropium once daily and their combination in patients with copd
    Respiratory Medicine, 2009
    Co-Authors: Donald P Tashkin, James F Donohue, Donald A Mahler, Holly Huang, Elizabeth B Goodwin, Kendyl Schaefer, John P Hanrahan, William T Andrews
    Abstract:

    PURPOSE: Current guidelines support using in combination more than one class of long-acting bronchodilator for COPD patients whose symptoms are not controlled by mono-therapy. This 2-week, multi-center (34 sites), randomized, modified-blind, parallel group study evaluated the efficacy and safety of concomitant treatment with nebulized arformoterol (the formoterol(R,R)-isomer) BID and tiotropium DPI QD. METHODS: COPD patients (mean FEV(1) 1.37L, 45.4% predicted) were randomized to receive mono-therapy (either arformoterol 15microg BID [n=76] or tiotropium 18microg QD [n=80]), or combined therapy (sequential dosing of arformoterol 15microg BID and tiotropium 18microg QD [n=78]). Changes in pulmonary function, dyspnea, and rescue Levalbuterol use were evaluated, as were safety outcomes. RESULTS: Mean FEV(1)AUC(0-24) (the primary endpoint) improved similarly from baseline for arformoterol (0.10L) and tiotropium (0.08L) treatment groups and greater for the combined therapy group (0.22L; all p-values <0.005). Peak FEV(1), peak FVC, 24-h trough FEV(1), and inspiratory capacity also improved similarly for the mono-therapies and greatest for the combined therapy. Dyspnea (mean transition dyspnea index) improved similarly for arformoterol (+2.3) and tiotropium (+1.8) and greatest with combined therapy (+3.1; p-values <0.05). Levalbuterol use decreased for all treatment groups (range -1.8 to -2.5 actuations/day). All treatments had similar frequency of adverse events. CONCLUSION: In this study, the combination of nebulized arformoterol 15microg BID plus tiotropium 18microg DPI QD was the most effective in improving pulmonary function and disease symptoms. Mono-therapy improvement with arformoterol or tiotropium was similar. All three treatments were well tolerated.

  • Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD.
    Respiratory Medicine, 2009
    Co-Authors: Donald P Tashkin, James F Donohue, Donald A Mahler, Holly Huang, Kendyl Schaefer, E. Goodwin, John P Hanrahan, William T Andrews
    Abstract:

    PURPOSE: Current guidelines support using in combination more than one class of long-acting bronchodilator for COPD patients whose symptoms are not controlled by mono-therapy. This 2-week, multi-center (34 sites), randomized, modified-blind, parallel group study evaluated the efficacy and safety of concomitant treatment with nebulized arformoterol (the formoterol(R,R)-isomer) BID and tiotropium DPI QD. METHODS: COPD patients (mean FEV(1) 1.37L, 45.4% predicted) were randomized to receive mono-therapy (either arformoterol 15microg BID [n=76] or tiotropium 18microg QD [n=80]), or combined therapy (sequential dosing of arformoterol 15microg BID and tiotropium 18microg QD [n=78]). Changes in pulmonary function, dyspnea, and rescue Levalbuterol use were evaluated, as were safety outcomes. RESULTS: Mean FEV(1)AUC(0-24) (the primary endpoint) improved similarly from baseline for arformoterol (0.10L) and tiotropium (0.08L) treatment groups and greater for the combined therapy group (0.22L; all p-values

  • comparison of Levalbuterol and racemic albuterol in hospitalized patients with acute asthma or copd a 2 week multicenter randomized open label study
    Clinical Therapeutics, 2008
    Co-Authors: James F Donohue, Kendyl Schaefer, William T Andrews, Raymond Claus, Nicola A Hanania, Ronald L Ciubotaru, David J Pasta, James M Roach
    Abstract:

    Abstract Background: The National Heart, Lung, and Blood Institute guideline recommends that dosing racemic albuterol be administered every 1 to 4 hours for treating patients with asthma or chronic obstructive pulmonary disease (COPD) in the hospital. Previously published preliminary and retrospective studies suggested that Levalbuterol can be administered every 8 hours for the treatment of bronchoconstriction in hospitalized patients. However, it is unclear how the different dosing regimens affect the total number of nebulizations (scheduled plus as-needed treatments) and the costs of treatment of bronchoconstriction in a hospital setting. Moreover, it is not clear how the different dosing regimens affect symptom outcomes and health status in hospitalized patients with asthma or COPD. Objective: The aim of this study was to evaluate these issues in hospitalized patients with acute asthma or COPD. Methods: In this prospective, multicenter, randomized, open-label study, hospitalized patients aged ≥18 years were randomly assigned to receive 14-day treatment with Levalbuterol 1.25 mg q6-8h or racemic albuterol 2.5 mg q1-4h, administered per routine hospital practice at each institution. The primary efficacy end point was total number of nebulizations during hospitalization. Pulmonary function, symptom evaluation (subject general well-being score [SGWB], disease symptom assessment [DSA], and β-mediated adverse effect scores), hospital costs (excluding medication costs) and hospital length of stay (LOS) were also evaluated. Results: In the intent-to-ttreat population (n = 479; Levalbuterol, 241;racemic albuterol, 238), the mean (SE) age was 55.3 (16.9) years, the majority of patients were white (57.8%), and the mean (SE) weight was 80.9 (24.5) kg. Demographic characteristics were similar between the 2 treatment groups, except that there were more females with COPD in the Levalbuterol treatment group (63.88%) compared with the racemic albuterol treatment group (45.5%) ( P = 0.005). Patients treated with Levalbuterol required significantly fewer median total nebulizations (10 vs 12; P = 0.031) and scheduled nebulizations (9 vs 11; P = 0.009) compared with those in the racemic albuterol group. The 2 treatment groups required 0 rescue nebulizations. Mean (SD) forced expiratory volume in 1 second improved from baseline with both Levalbuterol and racemic albuterol (0.06 [0.43] and 0.10 [0.37] L, respectively); these improvements were maintained throughout the hospital stay (0.11 [0.48] and 0.16 [0.52] L). DSA and SGWB scores improved significantly from baseline in both treatment groups, and β-mediated adverse effects mean scores were significantly greater with Levalbuterol versus racemic albuterol ( P Conclusions: In these hospitalized patients with acute asthma or COPD treated with Levalbuterol every 6 to 8 hours or racemic albuterol every 1 to 4 hours, significantly fewer total nebulizations were required with Levalbuterol, without an increased need for rescue nebulizations during 14 days of hospitalization. Both treatments were associated with improvements from baseline in symptoms and health status. The costs of treating bronchoconstriction in hospitalized patients were similar between the Levalbuterol and racemic albuterol groups.

  • evaluation of the efficacy and safety of Levalbuterol in subjects with copd
    COPD: Journal of Chronic Obstructive Pulmonary Disease, 2006
    Co-Authors: James F Donohue, Kendyl Schaefer, Merdad V Parsey, Raymond Claus, Charles Andrews, Tony Durzo, Satyendra Sharma, Rudolf A Baumgartner
    Abstract:

    The efficacy and safety of nebulized Levalbuterol in adults with chronic obstructive pulmonary disease (COPD) was evaluated in this multicenter, randomized, double-blind, parallel design study. Randomized subjects (n = 209) received Levalbuterol (LEV) 0.63 mg or 1.25 mg, racemic albuterol (RAC) 2.5 mg, or placebo (PBO) TID for 6 weeks. Serial spirometry was completed in-clinic after study drug alone (weeks 0, 2, and 6) or in combination with ipratropium bromide 0.5 mg (week 4). The primary endpoint was the averaged FEV1 AUC(0–8 hrs) over weeks 0, 2 and 6 compared with placebo. Other endpoints included rescue medication use, safety parameters, COPD exacerbations, and global evaluations. All active treatments demonstrated improvements in the percent change in FEV1 AUC(0–8 hrs) over the double-blind period and at each visit vs PBO (p < 0.05). Rescue medication use vs. baseline (doses/day) changed over time: PBO +0.38 ± 3.3; LEV 0.63 mg +0.07 ± 3.3; LEV 1.25 mg −0.84 ± 3.8 (p = 0.02 vs. RAC); RAC +0.97 ± 2.5....

Kendyl Schaefer - One of the best experts on this subject based on the ideXlab platform.

  • Comparison of Levalbuterol and racemic albuterol in hospitalized patients with acute asthma or COPD: a 2-week, multicenter, randomized, open-label study.
    Clinical therapeutics, 2020
    Co-Authors: James F Donohue, Kendyl Schaefer, William T Andrews, Raymond Claus, Nicola A Hanania, Ronald L Ciubotaru, David J Pasta, James Roach
    Abstract:

    The National Heart, Lung, and Blood Institute guideline recommends that dosing racemic albuterol be administered every 1 to 4 hours for treating patients with asthma or chronic obstructive pulmonary disease (COPD) in the hospital. Previously published preliminary and retrospective studies suggested that Levalbuterol can be administered every 8 hours for the treatment of bronchoconstriction in hospitalized patients. However, it is unclear how the different dosing regimens affect the total number of nebulizations (scheduled plus as-needed treatments) and the costs of treatment of bronchoconstriction in a hospital setting. Moreover, it is not clear how the different dosing regimens affect symptom outcomes and health status in hospitalized patients with asthma or COPD. The aim of this study was to evaluate these issues in hospitalized patients with acute asthma or COPD. In this prospective, multicenter, randomized, open-label study, hospitalized patients aged > or = 18 years were randomly assigned to receive 14-day treatment with Levalbuterol 1.25 mg q6-8h or racemic albuterol 2.5 mg q1-4h, administered per routine hospital practice at each institution. The primary efficacy end point was total number of nebulizations during hospitalization. Pulmonary function, symptom evaluation (subject general well-being score [SGWB], disease symptom assessment [DSA], and beta-mediated adverse effect scores), hospital costs (excluding medication costs) and hospital length of stay (LOS) were also evaluated. In the intent-to-treat population (n = 479; Levalbuterol, 241;racemic albuterol, 238), the mean (SE) age was 55.3 (16.9) years, the majority of patients were white (57.8%), and the mean (SE) weight was 80.9 (24.5) kg. Demographic characteristics were similar between the 2 treatment groups, except that there were more females with COPD in the Levalbuterol treatment group (63.88%) compared with the racemic albuterol treatment group (45.5%) (P = 0.005). Patients treated with Levalbuterol required significantly fewer median total nebulizations (10 vs 12; P = 0.031) and scheduled nebulizations (9 vs 11; P = 0.009) compared with those in the racemic albuterol group. The 2 treatment groups required 0 rescue nebulizations. Mean (SD) forced expiratory volume in 1 second improved from baseline with both Levalbuterol and racemic albuterol (0.06 [0.43] and 0.10 [0.37] L, respectively); these improvements were maintained throughout the hospital stay (0.11 [0.48] and 0.16 [0.52] L). DSA and SGWB scores improved significantly from baseline in both treatment groups, and beta-mediated adverse effects mean scores were significantly greater with Levalbuterol versus racemic albuterol (P < 0.001). In the Levalbuterol and racemic albuterol treatment groups, hospital LOS (70.6 and 65.7 hours, respectively), time to discharge (66.0 and 62.8 hours), and total hospital costs (least squares mean [SE], US $4869.30 [$343.58] and $4899.41 [$343.20]) were similar. In these hospitalized patients with acute asthma or COPD treated with Levalbuterol every 6 to 8 hours or racemic albuterol every 1 to 4 hours, significantly fewer total nebulizations were required with Levalbuterol, without an increased need for rescue nebulizations during 14 days of hospitalization. Both treatments were associated with improvements from baseline in symptoms and health status. The costs of treating bronchoconstriction in hospitalized patients were similar between the Levalbuterol and racemic albuterol groups.

  • effects of arformoterol twice daily tiotropium once daily and their combination in patients with copd
    Respiratory Medicine, 2009
    Co-Authors: Donald P Tashkin, James F Donohue, Donald A Mahler, Holly Huang, Elizabeth B Goodwin, Kendyl Schaefer, John P Hanrahan, William T Andrews
    Abstract:

    PURPOSE: Current guidelines support using in combination more than one class of long-acting bronchodilator for COPD patients whose symptoms are not controlled by mono-therapy. This 2-week, multi-center (34 sites), randomized, modified-blind, parallel group study evaluated the efficacy and safety of concomitant treatment with nebulized arformoterol (the formoterol(R,R)-isomer) BID and tiotropium DPI QD. METHODS: COPD patients (mean FEV(1) 1.37L, 45.4% predicted) were randomized to receive mono-therapy (either arformoterol 15microg BID [n=76] or tiotropium 18microg QD [n=80]), or combined therapy (sequential dosing of arformoterol 15microg BID and tiotropium 18microg QD [n=78]). Changes in pulmonary function, dyspnea, and rescue Levalbuterol use were evaluated, as were safety outcomes. RESULTS: Mean FEV(1)AUC(0-24) (the primary endpoint) improved similarly from baseline for arformoterol (0.10L) and tiotropium (0.08L) treatment groups and greater for the combined therapy group (0.22L; all p-values <0.005). Peak FEV(1), peak FVC, 24-h trough FEV(1), and inspiratory capacity also improved similarly for the mono-therapies and greatest for the combined therapy. Dyspnea (mean transition dyspnea index) improved similarly for arformoterol (+2.3) and tiotropium (+1.8) and greatest with combined therapy (+3.1; p-values <0.05). Levalbuterol use decreased for all treatment groups (range -1.8 to -2.5 actuations/day). All treatments had similar frequency of adverse events. CONCLUSION: In this study, the combination of nebulized arformoterol 15microg BID plus tiotropium 18microg DPI QD was the most effective in improving pulmonary function and disease symptoms. Mono-therapy improvement with arformoterol or tiotropium was similar. All three treatments were well tolerated.

  • Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD.
    Respiratory Medicine, 2009
    Co-Authors: Donald P Tashkin, James F Donohue, Donald A Mahler, Holly Huang, Kendyl Schaefer, E. Goodwin, John P Hanrahan, William T Andrews
    Abstract:

    PURPOSE: Current guidelines support using in combination more than one class of long-acting bronchodilator for COPD patients whose symptoms are not controlled by mono-therapy. This 2-week, multi-center (34 sites), randomized, modified-blind, parallel group study evaluated the efficacy and safety of concomitant treatment with nebulized arformoterol (the formoterol(R,R)-isomer) BID and tiotropium DPI QD. METHODS: COPD patients (mean FEV(1) 1.37L, 45.4% predicted) were randomized to receive mono-therapy (either arformoterol 15microg BID [n=76] or tiotropium 18microg QD [n=80]), or combined therapy (sequential dosing of arformoterol 15microg BID and tiotropium 18microg QD [n=78]). Changes in pulmonary function, dyspnea, and rescue Levalbuterol use were evaluated, as were safety outcomes. RESULTS: Mean FEV(1)AUC(0-24) (the primary endpoint) improved similarly from baseline for arformoterol (0.10L) and tiotropium (0.08L) treatment groups and greater for the combined therapy group (0.22L; all p-values

  • comparison of Levalbuterol and racemic albuterol in hospitalized patients with acute asthma or copd a 2 week multicenter randomized open label study
    Clinical Therapeutics, 2008
    Co-Authors: James F Donohue, Kendyl Schaefer, William T Andrews, Raymond Claus, Nicola A Hanania, Ronald L Ciubotaru, David J Pasta, James M Roach
    Abstract:

    Abstract Background: The National Heart, Lung, and Blood Institute guideline recommends that dosing racemic albuterol be administered every 1 to 4 hours for treating patients with asthma or chronic obstructive pulmonary disease (COPD) in the hospital. Previously published preliminary and retrospective studies suggested that Levalbuterol can be administered every 8 hours for the treatment of bronchoconstriction in hospitalized patients. However, it is unclear how the different dosing regimens affect the total number of nebulizations (scheduled plus as-needed treatments) and the costs of treatment of bronchoconstriction in a hospital setting. Moreover, it is not clear how the different dosing regimens affect symptom outcomes and health status in hospitalized patients with asthma or COPD. Objective: The aim of this study was to evaluate these issues in hospitalized patients with acute asthma or COPD. Methods: In this prospective, multicenter, randomized, open-label study, hospitalized patients aged ≥18 years were randomly assigned to receive 14-day treatment with Levalbuterol 1.25 mg q6-8h or racemic albuterol 2.5 mg q1-4h, administered per routine hospital practice at each institution. The primary efficacy end point was total number of nebulizations during hospitalization. Pulmonary function, symptom evaluation (subject general well-being score [SGWB], disease symptom assessment [DSA], and β-mediated adverse effect scores), hospital costs (excluding medication costs) and hospital length of stay (LOS) were also evaluated. Results: In the intent-to-ttreat population (n = 479; Levalbuterol, 241;racemic albuterol, 238), the mean (SE) age was 55.3 (16.9) years, the majority of patients were white (57.8%), and the mean (SE) weight was 80.9 (24.5) kg. Demographic characteristics were similar between the 2 treatment groups, except that there were more females with COPD in the Levalbuterol treatment group (63.88%) compared with the racemic albuterol treatment group (45.5%) ( P = 0.005). Patients treated with Levalbuterol required significantly fewer median total nebulizations (10 vs 12; P = 0.031) and scheduled nebulizations (9 vs 11; P = 0.009) compared with those in the racemic albuterol group. The 2 treatment groups required 0 rescue nebulizations. Mean (SD) forced expiratory volume in 1 second improved from baseline with both Levalbuterol and racemic albuterol (0.06 [0.43] and 0.10 [0.37] L, respectively); these improvements were maintained throughout the hospital stay (0.11 [0.48] and 0.16 [0.52] L). DSA and SGWB scores improved significantly from baseline in both treatment groups, and β-mediated adverse effects mean scores were significantly greater with Levalbuterol versus racemic albuterol ( P Conclusions: In these hospitalized patients with acute asthma or COPD treated with Levalbuterol every 6 to 8 hours or racemic albuterol every 1 to 4 hours, significantly fewer total nebulizations were required with Levalbuterol, without an increased need for rescue nebulizations during 14 days of hospitalization. Both treatments were associated with improvements from baseline in symptoms and health status. The costs of treating bronchoconstriction in hospitalized patients were similar between the Levalbuterol and racemic albuterol groups.

  • an evaluation of Levalbuterol hfa in the prevention of exercise induced bronchospasm
    Journal of Asthma, 2007
    Co-Authors: D S Pearlman, Holly Huang, Kendyl Schaefer, William Rees, William T Andrews
    Abstract:

    Background. Exercise-induced bronchospasm (EIB) affects up to 90% of all patients with asthma. Objective. This study evaluated the ability of Levalbuterol hydrofluoroalkane (HFA) 90 μg (two actuations of 45 μg) administered via metered dose inhaler (MDI) to protect against EIB in mild-to-moderate asthmatics. Methods. This was a randomized, double-blind, placebo-controlled, two-way cross-over study. Patients with asthma (n = 15) were ≥18 years, had a ≥6-month history of EIB, ≥ 70% baseline predicted forced expiratory volume in 1 second (FEV1), and a 20% to 50% decrease in FEV1 after treadmill exercise challenge using single-blind placebo MDI. Levalbuterol or placebo was self-administered 30 minutes before exercise. Treatment sequences were separated by a 3-to 7-day washout period. Spirometry was performed predose, 20 minutes postdose/pre-exercise, and 5, 10, 15, 30, and 60 minutes post-exercise. The primary endpoint was the maximum percent decrease in FEV1 from baseline (postdose/pre-exercise). The percent...

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  • a cumulative dose safety and tolerability study of arformoterol in pediatric subjects with stable asthma
    Pediatric Pulmonology, 2011
    Co-Authors: Jacob Hinkle, Lisa Curry, Kenneth Sciarappa, Elizabeth B Goodwin, J Hinson, Edward Kerwin, John P Hanrahan
    Abstract:

    Purpose Short-acting β2-agonists (SABAs) are recommended for treating acute pediatric asthma. The long-acting β2-agonist (LABA) arformoterol is approved for the maintenance treatment of chronic obstructive pulmonary disease (COPD). Arformoterol acts rapidly, is delivered via nebulization, and, as such, raises concerns from the FDA over possible off-label use in acute asthma in children. As a step to investigate this issue, this study evaluated the safety and tolerability of three consecutive doses of arformoterol administered over 1 hr in children with stable asthma. Methods This study consisted of a double-blind, crossover period in which subjects (ages 2–11 years) with stable asthma were randomized to three consecutive nebulized doses of arformoterol (7.5 µg/dose) or Levalbuterol (0.63 mg/dose) administered over 1-hr (0, 30, and 60 min) followed by an open-label period with three consecutive doses of arformoterol (15 µg/dose) administered over 1 hr. Endpoints were change in heart rate, blood pressure, and serum potassium and glucose levels. Other endpoints included adverse events and pulmonary function. Results There were no clinically important mean changes from pre-dose in heart rate, blood pressure, or serum glucose levels, across treatment groups. Substantial declines in serum potassium levels were observed both 2 and 6 hr post-dosing. Two subjects had declines to 2.8 mEq/L and 2.9 mEq/L 2-hr post-dosing. Adverse events were infrequent and differences in forced expiratory volume in 1 sec and peak expiratory flow across treatment groups were not clinically meaningful. Conclusion In this study, in children with stable asthma, three consecutive doses of arformoterol (7.5 and 15 µg) and Levalbuterol were overall well tolerated. Nonetheless, serum potassium levels demonstrated substantial mean declines after dosing. These findings do not address or support the safety and tolerability of arformoterol use in acute exacerbations of asthma in children. Pediatr. Pulmonol. 2011; 46:761–769. © 2011 Wiley-Liss, Inc.

  • effects of arformoterol twice daily tiotropium once daily and their combination in patients with copd
    Respiratory Medicine, 2009
    Co-Authors: Donald P Tashkin, James F Donohue, Donald A Mahler, Holly Huang, Elizabeth B Goodwin, Kendyl Schaefer, John P Hanrahan, William T Andrews
    Abstract:

    PURPOSE: Current guidelines support using in combination more than one class of long-acting bronchodilator for COPD patients whose symptoms are not controlled by mono-therapy. This 2-week, multi-center (34 sites), randomized, modified-blind, parallel group study evaluated the efficacy and safety of concomitant treatment with nebulized arformoterol (the formoterol(R,R)-isomer) BID and tiotropium DPI QD. METHODS: COPD patients (mean FEV(1) 1.37L, 45.4% predicted) were randomized to receive mono-therapy (either arformoterol 15microg BID [n=76] or tiotropium 18microg QD [n=80]), or combined therapy (sequential dosing of arformoterol 15microg BID and tiotropium 18microg QD [n=78]). Changes in pulmonary function, dyspnea, and rescue Levalbuterol use were evaluated, as were safety outcomes. RESULTS: Mean FEV(1)AUC(0-24) (the primary endpoint) improved similarly from baseline for arformoterol (0.10L) and tiotropium (0.08L) treatment groups and greater for the combined therapy group (0.22L; all p-values <0.005). Peak FEV(1), peak FVC, 24-h trough FEV(1), and inspiratory capacity also improved similarly for the mono-therapies and greatest for the combined therapy. Dyspnea (mean transition dyspnea index) improved similarly for arformoterol (+2.3) and tiotropium (+1.8) and greatest with combined therapy (+3.1; p-values <0.05). Levalbuterol use decreased for all treatment groups (range -1.8 to -2.5 actuations/day). All treatments had similar frequency of adverse events. CONCLUSION: In this study, the combination of nebulized arformoterol 15microg BID plus tiotropium 18microg DPI QD was the most effective in improving pulmonary function and disease symptoms. Mono-therapy improvement with arformoterol or tiotropium was similar. All three treatments were well tolerated.

  • Effects of arformoterol twice daily, tiotropium once daily, and their combination in patients with COPD.
    Respiratory Medicine, 2009
    Co-Authors: Donald P Tashkin, James F Donohue, Donald A Mahler, Holly Huang, Kendyl Schaefer, E. Goodwin, John P Hanrahan, William T Andrews
    Abstract:

    PURPOSE: Current guidelines support using in combination more than one class of long-acting bronchodilator for COPD patients whose symptoms are not controlled by mono-therapy. This 2-week, multi-center (34 sites), randomized, modified-blind, parallel group study evaluated the efficacy and safety of concomitant treatment with nebulized arformoterol (the formoterol(R,R)-isomer) BID and tiotropium DPI QD. METHODS: COPD patients (mean FEV(1) 1.37L, 45.4% predicted) were randomized to receive mono-therapy (either arformoterol 15microg BID [n=76] or tiotropium 18microg QD [n=80]), or combined therapy (sequential dosing of arformoterol 15microg BID and tiotropium 18microg QD [n=78]). Changes in pulmonary function, dyspnea, and rescue Levalbuterol use were evaluated, as were safety outcomes. RESULTS: Mean FEV(1)AUC(0-24) (the primary endpoint) improved similarly from baseline for arformoterol (0.10L) and tiotropium (0.08L) treatment groups and greater for the combined therapy group (0.22L; all p-values

  • a cumulative dose study of Levalbuterol and racemic albuterol administered by hydrofluoroalkane 134a metered dose inhaler in asthmatic subjects
    The Journal of Allergy and Clinical Immunology, 2008
    Co-Authors: Kenneth Tripp, Elizabeth B Goodwin, W W Pleskow, Rudolf A Baumgartner, William K Mcvicar, Parameswaran Nair, Jonathan Corren, John P Hanrahan
    Abstract:

    Background The short-acting β 2 -agonists Levalbuterol and racemic albuterol are available for administration through a hydrofluoroalkane-134a (HFA) metered-dose inhaler (MDI). Objective This study compared the short-term safety and efficacy of cumulative doses of Levalbuterol HFA MDI and racemic albuterol HFA MDI in asthmatic subjects. Methods This was a randomized, modified-blind, active-controlled, multicenter, 2-way crossover study. Subjects (n = 49) were randomized to 16 cumulative doses (1×, 2×, 4×, 8×, and 16×) of Levalbuterol (45 μg per dose) or racemic albuterol (90 μg per dose) administered over a 2-hour period. After a 7-day washout period, subjects were crossed over to the other treatment. After each dose, safety outcomes and pulmonary function were assessed. Results Heart rate and (R)-albuterol exposure increased for both racemic albuterol HFA and Levalbuterol HFA. For cumulative doses of 8× or greater, racemic albuterol HFA treatment had greater increases in mean heart rate than Levalbuterol HFA (least-squares mean [± SD] difference at the 8× dose was 2.8 beats/min [95% CI, 0.3-5.3] and at the 16× dose was 3.5 beats/min [95% CI, 0.6-6.4]). (R)-albuterol plasma levels ranged from 10% to 18% higher after racemic albuterol HFA MDI dosing versus after Levalbuterol HFA MDI. FEV 1 improvements were similar for both treatments. The relative potencies of the 2 therapies, based on FEV 1 , were similar (ratio, 1.1 [90% CI, 0.9-1.2]; Finney method). Conclusion In this study single-day cumulative dosing of asthmatic subjects with Levalbuterol HFA MDI or racemic albuterol HFA MDI resulted in similar improvements in FEV 1 and tolerability. Plasma (R)-albuterol levels and mean heart rate were less with Levalbuterol HFA MDI.