The Experts below are selected from a list of 150 Experts worldwide ranked by ideXlab platform
Tushar Shah - One of the best experts on this subject based on the ideXlab platform.
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salmeterol and fluticasone propionate combined in a new powder Inhalation Device for the treatment of asthma a randomized double blind placebo controlled trial
The Journal of Allergy and Clinical Immunology, 2000Co-Authors: Mani S Kavuru, Anita Woodring, Leslie Baitinger, Karen W House, Barbara A Prillaman, Julian Melamed, Gary Gross, Craig Laforce, Tushar ShahAbstract:Abstract Background: Many patients with persistent asthma need both long-acting bronchodilators and inhaled corticosteroids for optimal asthma control. Objective: Our purpose was to compare the efficacy and safety of salmeterol 50 μg combined with fluticasone 100 μg (in a combination dry powder product) with that of placebo, fluticasone, or salmeterol alone. Methods: A 12-week randomized, double-blind, multicenter study was conducted in 356 patients aged 12 years or older with asthma. After a 14-day screening period, patients were randomized to treatment with salmeterol 50 μg combined with fluticasone 100 μg (combination product), salmeterol 50 μg, fluticasone 100 μg, or placebo administered in the Diskus dry powder inhaler (GlaxoWellcome, UK) twice daily. Results: Mean change in FEV 1 at end point was significantly ( P ≤ .003) greater with the combination product (0.51 L) compared with placebo (0.01 L), salmeterol (0.11 L), and flutica-sone (0.28 L). The combination product significantly increased ( P ≤ .013) area under the curve compared with placebo and fluticasone on day 1 and compared with placebo, salmeterol, and fluticasone at week 1 and week 12. Patients in the combination product group were less likely to withdraw from the study because of worsening asthma compared with those in the other groups ( P ≤ .020). The combination product significantly increased ( P ≤ .012) morning PEF (combination, 52.5 L/min; placebo, –23.7 L/min; salmeterol, –1.7 L/min; fluticasone, 17.3 L/min) and evening PEF at end point compared with the other groups. The combination product significantly ( P ≤ .025) reduced symptom scores and albuterol use compared with the other treatments and increased the percentage of nights with no awakenings and the percentage of days with no symptoms compared with placebo and salmeterol. All treatments were equally well tolerated. Conclusion: Salmeterol 50 μg and fluticasone 100 μg combined in the Diskus powder delivery Device offers significant clinical advantages over salmeterol or fluticasone alone at the same doses. (J Allergy Clin Immunol 2000;105:1108-16.)
James V. Cassella - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of loxapine for Inhalation in the treatment of agitation in patients with schizophrenia a randomized double blind placebo controlled trial
The Journal of Clinical Psychiatry, 2011Co-Authors: Michael H Allen, Daniel A. Spyker, Patrik Munzar, Michael D Lesem, David Feifel, Daniel L Zimbroff, Ruth Ross, James V. CassellaAbstract:Objective The objective of this study was to assess the efficacy and safety of inhaled loxapine in the treatment of agitation in patients with psychotic disorders. Method In this randomized, double-blind, placebo-controlled study, 129 agitated patients with schizophrenia or schizoaffective disorder (DSM-IV criteria) were randomized to receive in a clinical or hospital setting a single Inhalation of 5 or 10 mg of loxapine or placebo administered using the Staccato loxapine for Inhalation Device. The Inhalation Device delivered thermally generated drug aerosol to the deep lung for rapid absorption. The primary efficacy measure was change on the Positive and Negative Syndrome Scale-excited component (PANSS-EC) 2 hours following treatment. Secondary outcomes included the Clinical Global Impressions-Improvement scale (CGI-I), Behavioral Activity Rating Scale (BARS), and time to first rescue medication. The study was conducted between September 2006 and January 2007. Results Differences were statistically significant (P Conclusions Inhaled loxapine was generally safe and well tolerated and produced rapid improvement in agitated patients with psychotic disorders. Statistically significant differences in efficacy were found for the 10-mg dose compared with placebo, with results suggesting 5 mg may be effective. The delivery of loxapine by Inhalation may provide a rapid, well-tolerated option for treating acute psychotic agitation that allows patients to avoid the aversive effects and loss of autonomy often associated with use of intramuscular medications. Further investigation of this new loxapine formulation is warranted. Trial registration ClinicalTrials.gov identifier: NCT00369577.
Karen W House - One of the best experts on this subject based on the ideXlab platform.
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pharmacokinetic pharmacodynamic efficacy and safety data from two randomized double blind studies in patients with asthma and an in vitro study comparing two dry powder inhalers delivering a combination of salmeterol 50 μg and fluticasone propionate
Clinical Therapeutics, 2009Co-Authors: Peter T Daleyyates, Karen W House, David A Parkins, Marian J Thomas, Benjamin Gillett, Hector OrtegaAbstract:Abstract Background: The use of dry-powder inhalers (DPIs) to administer respiratory medicines is increasing, and new DPIs are likely to be developed because of expiring patents. However, there is considerable debate concerning the extent to which DPIs are interchangeable without altering disease control or the safety profile of the treatment. Objective: This study was designed to compare the pharmacokinetic (PK), pharmacodynamic (PD), efficacy, and safety data for 2 DPIs delivering a combination of salmeterol 50 μg plus fluticasone propionate (FP) 250 μg (SFC 50/250) to investigate assumptions of bioequivalence. Methods: Three studies compared SFC 50/250 delivery using a reservoir powder Inhalation Device (RPID) and a Diskus® multiple-dose inhaler: an in vitro assessment of fine-particle-mass (FPM) profiles of the emitted doses; a PK/PD study of SFC 50/250 administered in two 14-day crossover treatment periods to 22 adults with moderate, persistent asthma to determine the equivalence of the RPID and Diskus inhaler in terms of drug delivery and systemic exposure; and a 12-week clinical efficacy and safety study of SFC 50/250 in 270 patients ≥12 years of age with moderate, persistent asthma to assess the equivalence of the RPID and Diskus inhaler based on peak expiratory flow (PEF) rates. FPM was summed from the quantity of active pharmaceutical ingredient deposited on stages 1 to 5 of a cascade impactor, representing an aerodynamic particle size range of 0.8 to 6.2 μm. Systemic exposure to SFC 50/250 was declared no greater with RPID than with the Diskus inhaler if the upper limit of the 90% CI for the ratio of FP AUC for the 2 Devices was below the upper limit of the equivalence range (ie, Results: In vitro, mean FPM values for the RPID and Diskus inhaler, respectively, were 13.1 and 12.8 μg/dose for salmeterol ( P = NS) and 66.8 and 66.2 μg/dose for FP ( P = NS). The only notable differences were mean FP for particle sizes 2.3 to 3.2 μm (21.4 μg/dose for RPID, 25.6 μg/dose for Diskus) and for sizes 4.0 to 6.2 μm (17.3 μg/dose for RPID, 11.7 μg/dose for Diskus). In the PK/PD study, there were 22 patients (16 men and 6 women), most (86%) of whom were white. Mean (SD) age was 26.0 (5.0) years (range, 19-35 years), and mean (SD) weight was 67.3 (8.9) kg. The 2 inhalers did not meet the criteria for declaring bioequivalence: estimated ratios (RPID:Diskus) were 2.00 (90% CI, 1.56 to 2.55) for FP AUC up to the time point of next dosing and 1.92 (90% CI, 1.64 to 2.25) for salmeterol maximum observed plasma concentration at the end of the dosing interval (at steady state). Urine cortisol (0–24 hours) was significantly lower for the RPID than for the Diskus inhaler (ratio, 0.74 [95% CI, 0.57 to 0.96]; P = 0.026); no significant difference in plasma cortisol was noted between the 2 inhalers (ratio, 0.85 [95% CI, 0.7 to 1.04]). A small but statistically significant increase in maximum heart rate (5 beats/min) was noted in the RPID group (ratio, 1.05 [95% CI, 1.01 to 1.10]; P = 0.029). No notable differences in other PD end points were observed. Drug-related adverse events occurred in both groups (2 [dysphagia and tremor] in the RPID group and 3 [2 cases of dysphonia, 1 case of mucous-membrane irritation] in the Diskus group). There were 270 patients (136 females, 134 males) in the clinical efficacy and safety study, most (94%) of whom were white; mean (SD) age was 37.2 (17.0) years (range, 11–77 years) in the RPID group and 35.4 (17.2) years (range, 12–77 years) in the Diskus group. The RPID and the Diskus inhaler met the predefined equivalence criteria (±15 L/min) in terms of mean change in morning PEF from baseline: 3.9 L/min (95% CI, -3.1 to 11.0). The 2 SFC 50/250 inhalers were well tolerated; the most frequently reported adverse event was bronchitis, reported by 12% of the patients in the RPID group and 9% of those in the Diskus group. The only serious adverse event, which occurred in the RPID group and was related to bronchial infection, was considered unrelated to treatment. Conclusions: In vitro particle size distribution data were potentially superimposable for the RPID and the Diskus inhaler. The 2 Devices were considered to be clinically equivalent in terms of mean morning PEF but were not considered equivalent in terms of PK systemic exposure. The 2 SFC 50/250 inhalers were well tolerated and had comparable safety profiles; no serious adverse events were attributed to the study product.
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salmeterol and fluticasone propionate combined in a new powder Inhalation Device for the treatment of asthma a randomized double blind placebo controlled trial
The Journal of Allergy and Clinical Immunology, 2000Co-Authors: Mani S Kavuru, Anita Woodring, Leslie Baitinger, Karen W House, Barbara A Prillaman, Julian Melamed, Gary Gross, Craig Laforce, Tushar ShahAbstract:Abstract Background: Many patients with persistent asthma need both long-acting bronchodilators and inhaled corticosteroids for optimal asthma control. Objective: Our purpose was to compare the efficacy and safety of salmeterol 50 μg combined with fluticasone 100 μg (in a combination dry powder product) with that of placebo, fluticasone, or salmeterol alone. Methods: A 12-week randomized, double-blind, multicenter study was conducted in 356 patients aged 12 years or older with asthma. After a 14-day screening period, patients were randomized to treatment with salmeterol 50 μg combined with fluticasone 100 μg (combination product), salmeterol 50 μg, fluticasone 100 μg, or placebo administered in the Diskus dry powder inhaler (GlaxoWellcome, UK) twice daily. Results: Mean change in FEV 1 at end point was significantly ( P ≤ .003) greater with the combination product (0.51 L) compared with placebo (0.01 L), salmeterol (0.11 L), and flutica-sone (0.28 L). The combination product significantly increased ( P ≤ .013) area under the curve compared with placebo and fluticasone on day 1 and compared with placebo, salmeterol, and fluticasone at week 1 and week 12. Patients in the combination product group were less likely to withdraw from the study because of worsening asthma compared with those in the other groups ( P ≤ .020). The combination product significantly increased ( P ≤ .012) morning PEF (combination, 52.5 L/min; placebo, –23.7 L/min; salmeterol, –1.7 L/min; fluticasone, 17.3 L/min) and evening PEF at end point compared with the other groups. The combination product significantly ( P ≤ .025) reduced symptom scores and albuterol use compared with the other treatments and increased the percentage of nights with no awakenings and the percentage of days with no symptoms compared with placebo and salmeterol. All treatments were equally well tolerated. Conclusion: Salmeterol 50 μg and fluticasone 100 μg combined in the Diskus powder delivery Device offers significant clinical advantages over salmeterol or fluticasone alone at the same doses. (J Allergy Clin Immunol 2000;105:1108-16.)
Mani S Kavuru - One of the best experts on this subject based on the ideXlab platform.
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salmeterol and fluticasone propionate combined in a new powder Inhalation Device for the treatment of asthma a randomized double blind placebo controlled trial
The Journal of Allergy and Clinical Immunology, 2000Co-Authors: Mani S Kavuru, Anita Woodring, Leslie Baitinger, Karen W House, Barbara A Prillaman, Julian Melamed, Gary Gross, Craig Laforce, Tushar ShahAbstract:Abstract Background: Many patients with persistent asthma need both long-acting bronchodilators and inhaled corticosteroids for optimal asthma control. Objective: Our purpose was to compare the efficacy and safety of salmeterol 50 μg combined with fluticasone 100 μg (in a combination dry powder product) with that of placebo, fluticasone, or salmeterol alone. Methods: A 12-week randomized, double-blind, multicenter study was conducted in 356 patients aged 12 years or older with asthma. After a 14-day screening period, patients were randomized to treatment with salmeterol 50 μg combined with fluticasone 100 μg (combination product), salmeterol 50 μg, fluticasone 100 μg, or placebo administered in the Diskus dry powder inhaler (GlaxoWellcome, UK) twice daily. Results: Mean change in FEV 1 at end point was significantly ( P ≤ .003) greater with the combination product (0.51 L) compared with placebo (0.01 L), salmeterol (0.11 L), and flutica-sone (0.28 L). The combination product significantly increased ( P ≤ .013) area under the curve compared with placebo and fluticasone on day 1 and compared with placebo, salmeterol, and fluticasone at week 1 and week 12. Patients in the combination product group were less likely to withdraw from the study because of worsening asthma compared with those in the other groups ( P ≤ .020). The combination product significantly increased ( P ≤ .012) morning PEF (combination, 52.5 L/min; placebo, –23.7 L/min; salmeterol, –1.7 L/min; fluticasone, 17.3 L/min) and evening PEF at end point compared with the other groups. The combination product significantly ( P ≤ .025) reduced symptom scores and albuterol use compared with the other treatments and increased the percentage of nights with no awakenings and the percentage of days with no symptoms compared with placebo and salmeterol. All treatments were equally well tolerated. Conclusion: Salmeterol 50 μg and fluticasone 100 μg combined in the Diskus powder delivery Device offers significant clinical advantages over salmeterol or fluticasone alone at the same doses. (J Allergy Clin Immunol 2000;105:1108-16.)
Michael H Allen - One of the best experts on this subject based on the ideXlab platform.
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efficacy and safety of loxapine for Inhalation in the treatment of agitation in patients with schizophrenia a randomized double blind placebo controlled trial
The Journal of Clinical Psychiatry, 2011Co-Authors: Michael H Allen, Daniel A. Spyker, Patrik Munzar, Michael D Lesem, David Feifel, Daniel L Zimbroff, Ruth Ross, James V. CassellaAbstract:Objective The objective of this study was to assess the efficacy and safety of inhaled loxapine in the treatment of agitation in patients with psychotic disorders. Method In this randomized, double-blind, placebo-controlled study, 129 agitated patients with schizophrenia or schizoaffective disorder (DSM-IV criteria) were randomized to receive in a clinical or hospital setting a single Inhalation of 5 or 10 mg of loxapine or placebo administered using the Staccato loxapine for Inhalation Device. The Inhalation Device delivered thermally generated drug aerosol to the deep lung for rapid absorption. The primary efficacy measure was change on the Positive and Negative Syndrome Scale-excited component (PANSS-EC) 2 hours following treatment. Secondary outcomes included the Clinical Global Impressions-Improvement scale (CGI-I), Behavioral Activity Rating Scale (BARS), and time to first rescue medication. The study was conducted between September 2006 and January 2007. Results Differences were statistically significant (P Conclusions Inhaled loxapine was generally safe and well tolerated and produced rapid improvement in agitated patients with psychotic disorders. Statistically significant differences in efficacy were found for the 10-mg dose compared with placebo, with results suggesting 5 mg may be effective. The delivery of loxapine by Inhalation may provide a rapid, well-tolerated option for treating acute psychotic agitation that allows patients to avoid the aversive effects and loss of autonomy often associated with use of intramuscular medications. Further investigation of this new loxapine formulation is warranted. Trial registration ClinicalTrials.gov identifier: NCT00369577.