PubMed | SkyePharma, Sofotec GmbH, S5 Consulting, Consulting Inc. and 3 more.
Type: Comparative Study | Journal: AAPS PharmSciTech | Year: 2016
Fine particle dose (FPD) is a critical quality attribute for orally inhaled products (OIPs). The abbreviated impactor measurement (AIM) concept simplifies its measurement, provided there is a validated understanding of the relationship with the full resolution pharmacopoeial impactor (PIM) data for a given product. This multi-center study compared fine particle dose determined using AIM and PIM for five dry powder inhaler (DPIs) and two pressurized metered-dose inhaler (pMDI) products, one of which included a valved holding chamber (VHC). Reference measurements of FPD
News Article | November 23, 2016
According to Stratistics MRC, the Global Anesthesia Vaporizers market is accounted for $xx million in 2015 and is expected to reach $xx million by 2022 growing at a CAGR of xx% from 2015 to 2022. The major drivers that are fostering the market growth include rising number of surgical procedures, increasing count of specialty hospitals, and attracting end-users through involvement in medical exhibitions. However, high cost of open surgeries is restricting the market size. Hospitals and Clinics segment accounted for highest revenue owing to rising number of entries to hospitals for surgical care. North America commanded the largest market share during the forecast period attributed to rising adoption of anesthesia vaporizers by hospital outpatient settings. Some of the key players in this market include GE Healthcare, Meditec International England, Spacelabs Healthcare, Beijing Vanbonmed, OES Medical, Drägerwerk AG & Co. KGaA, Penlon Limited Oricare Inc, Beijing Siriusmed Medical Device, CM-CC, NorVap, Beijing Yi Shiheng Electronic Technology, Medtronic plc, Piramal Healthcare and SkyePharma Inc. Products Covered: • Isoflurane • Sevoflurane • Desflurane • Propofol • Dexmedetomidine • Remifentanil • Midazolam • Other Products Applications Covered: • Maintenance anesthesia • Induction anesthesia End Users Covered: • Ambulatory surgical centers (ASCs) • Hospitals and clinics • Physician offices Regions Covered: • North America o US o Canada o Mexico • Europe o Germany o France o Italy o UK o Spain o Rest of Europe • Asia Pacific o Japan o China o India o Australia o New Zealand o Rest of Asia Pacific • Rest of the World o Middle East o Brazil o Argentina o South Africa o Egypt What our report offers: - Market share assessments for the regional and country level segments - Market share analysis of the top industry players - Strategic recommendations for the new entrants - Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations) - Strategic recommendations in key business segments based on the market estimations - Competitive landscaping mapping the key common trends - Company profiling with detailed strategies, financials, and recent developments - Supply chain trends mapping the latest technological advancements
Corren J.,Allergy Medical Clinic |
Mansfield L.E.,Western Sky Medical Research |
Pertseva T.,Dniepropetrovsk State Medical Academy |
Blahzko V.,Kharkov City Clinical Hospital 13 |
Respiratory Medicine | Year: 2013
Background: The inhaled corticosteroid, fluticasone propionate, and the long-acting β2-adrenergic agonist, formoterol fumarate, are both highly effective treatments for bronchial asthma. This study (NCT00393952/EudraCT number: 2006-005989-39) compared the efficacy and safety of fluticasone/formoterol combination therapy (flutiform®; 250/10 μg) administered twice daily (b.i.d.) via a single aerosol inhaler, with the individual components (fluticasone 250 μg b.i.d.; formoterol 10 μg b.i.d.), in adult and adolescent patients with moderate-to-severe asthma. Methods: This was a 12-week, double-blind, randomised, parallel-group, multicentre, placebocontrolled phase 3 study. The co-primary efficacy endpoints were: i) the mean change in the forced expiratory volume in the first second (FEV1) from morning pre-dose at baseline to pre-dose at week 12 (fluticasone/formoterol 250/10 μg vs. formoterol), ii) the mean change in FEV1 from morning pre-dose at baseline to 2 h post-dose at week 12 (fluticasone/formoterol 250/10 μg vs. fluticasone), and iii) the number of patients who discontinued prematurely due to lack of treatment efficacy (fluticasone/formoterol 250/10 μg vs. placebo). The secondary endpoints included measures of lung function, disease control, and asthma symptoms. Safety was assessed based on adverse events, vital signs, and clinical laboratory evaluations. Results: Overall, 395 (70.9%) patients completed the study. Fluticasone/formoterol 250/10 μg b.i.d. was superior to the individual components and placebo for all three co-primary endpoints and demonstrated numerically greater improvements for multiple secondary efficacy analyses. Fluticasone/formoterol combination therapy had a good safety profile over the 12 weeks. Conclusion: Fluticasone/formoterol combination therapy will provide clinicians with an efficacious alternative treatment option for patients with moderate-to-severe asthma.© 2012 Elsevier Ltd. All rights reserved.
Pearlman D.S.,Colorado Allergy and Asthma Centers |
LaForce C.F.,North Carolina Clinical Research Inc. |
Clinical Therapeutics | Year: 2013
Objectives: This study investigated the efficacy and tolerability of a new asthma therapy combining fluticasone propionate and formoterol fumarate (fluticasone/formoterol). **Trademark: Flutiform® (Jagotec AG, Muttenz, Switzerland)., administered twice daily (BID) via a single aerosol inhaler, compared with fluticasone propionate (fluticasone) or formoterol fumarate (formoterol) administered alone, in patients with mild to moderate asthma. Methods: Patients aged ≥12 years were evenly randomized to 12 weeks of treatment with fluticasone/formoterol (100/10 *g BID), fluticasone (100 *g BID), or formoterol (10 *g BID), in this multicenter, double-blind, parallel-group, study. The 2 coprimary end points were: (1) change in forced expiratory volume in 1 second (FEV1) from morning predose at baseline to predose at week12 for the comparison of the combination product with formoterol alone; and (2) change in FEV1 from morning predose at baseline to 2hours postdose at week 12 for the comparison of the combination product with fluticasone alone. The secondary objective was to demonstrate the efficacy of fluticasone/formoterol using other pulmonary function tests and clinical end points. Tolerability was assessed based on adverse events, clinical laboratory tests and vital sign evaluations. Results: Statistically significant differences were demonstrated for the 2 coprimary end points. Fluticasone/formoterol combination therapy showed significantly greater improvements from baseline to end of study in the change in predose FEV1 compared with formoterol (least squares [LS] mean treatment difference, 0.118 L [95% CI, 0.034-0.201; P = 0.006]) and the change in predose compared with 2 hours postdose FEV1 versus fluticasone (LS mean treatment difference, 0.122 L [95% CI, 0.040-0.204; P = 0.004]). Statistical analyses of the secondary efficacy endpoints revealed that evaluations of lung function, asthma exacerbations, asthma symptoms, rescue medication use and asthma control were supportive overall of the superior efficacy of fluticasone/formoterol combination therapy compared with its individual components; were supportive overall of the efficacy of fluticasone/formoterol combination therapy compared with its individual components. Since the secondary endpoints were analyzed using the sequential gatekeeper approach, only the mean change from baseline to final week in morning peak expiratory flow rate between the combination-therapy and formoterol groups returned statistically significant results (least squares mean difference, 20.05 [95% CI, 7.631-32.472; P = 0.002]). The fluticasone/formoterol combination therapy had a good tolerability profile over the 12-week treatment period. Conclusions: Fluticasone/formoterol had a good tolerability profile and showed statistically superior efficacy for the two co-primary endpoints compared to fluticasone or formoterol, in adolescents and adults with mild to moderate asthma. ClinicalTrials.gov identifier: NCT00394199. © 2013 Elsevier HS Journals, Inc.
Nathan R.A.,Asthma and Allergy Associates PC |
D'Urzo A.,University of Toronto |
Blazhko V.,Kharkov City Clinical Hospital and 13 |
BMC Pulmonary Medicine | Year: 2012
Background: This study investigated the efficacy and safety of a new asthma therapy combining fluticasone propionate and formoterol fumarate (fluticasone/formoterol; flutiform®), administered twice daily (b.i.d.) via a single aerosol inhaler, compared with its individual components administered separately and placebo, in patients with mild-to-moderate asthma.Methods: Patients aged ≥ 12 years were evenly randomised to 12 weeks of treatment with fluticasone/formoterol (100/10 μg b.i.d.), fluticasone (100 μg b.i.d.), formoterol (10 μg b.i.d.), or placebo, in this double-blind, parallel group, multicentre study. The three co-primary endpoints were: a) change in forced expiratory volume in the first second (FEV1) from morning pre-dose at baseline to pre-dose at week 12 for the comparison with formoterol; b) change in FEV1 from morning pre-dose at baseline to 2 hours post-dose at week 12 for the comparison with fluticasone, and c) time to discontinuation due to lack of efficacy from baseline to week 12 for the comparison with placebo. Safety was assessed based on adverse events, clinical laboratory tests and vital sign evaluations.Results: Statistically significant differences were demonstrated for all the three co-primary endpoints. Fluticasone/formoterol combination therapy showed significantly greater improvements from baseline to end of study in the change in pre-dose FEV1 compared with formoterol (Least Squares (LS) mean treatment difference: 0.101 L; 95% Confidence Interval (CI): 0.002, 0.199; p = 0.045) and the change in pre-dose compared with 2 hours post-dose FEV1 versus fluticasone (LS mean treatment difference: 0.200 L; 95% CI: 0.109, 0.292; p < 0.001). The time to discontinuation due to lack of efficacy was significantly longer for patients in the combination therapy group compared with those receiving placebo (p = 0.015). Overall, the results from multiple secondary endpoints assessing lung function, asthma symptoms, and rescue medication use supported the superior efficacy of the combination product compared with fluticasone, formoterol, and placebo. The fluticasone/formoterol combination therapy had a good safety and tolerability profile over the 12 week treatment period.Conclusions: Fluticasone/formoterol had a good safety and tolerability profile and showed statistically superior efficacy for the three co-primary endpoints compared to fluticasone, formoterol, and placebo, in adolescents and adults with mild-to-moderate asthma.EudraCT number: 2007-002866-36; US NCT number: NCT00393991. © 2012 Nathan et al.; licensee BioMed Central Ltd.
Pertseva T.,Dnepropetrovsk State Medical Academy |
Dissanayake S.,Mundipharma Research Ltd |
Current Medical Research and Opinion | Year: 2013
Objective: To demonstrate the efficacy and safety of fluticasone propionate/formoterol fumarate (flutiform*) in a pressurised metered-dose inhaler (pMDI) compared to two formulations of the fluticasone propionate component (Skyepharma fluticasone [SKP FP] or Flovent†, GlaxoSmithKline [GSK FP]) in adults and adolescents with moderate-to-severe asthma. Methods: Patients included in the study were ≥12 years, with symptomatic asthma for ≥1 year, steroid-requiring, had a forced expiratory volume in the first second (FEV1) of 40% to 80% (inclusive) of predicted normal values, and documented reversibility within 12 months of the study. Albuterol/salbuterol was given as rescue medication. The primary efficacy endpoint was the change in FEV1 from morning pre-dose at baseline (week 0) to 2 hours post-dose at week 12 for fluticasone/formoterol compared to SKP FP and, additionally, compared to GSK FP. Results: Fluticasone/formoterol was demonstrated to be statistically significantly superior to SKP FP. The least squares (LS) mean difference in FEV1 from baseline pre-dose to 2 hours post-dose at week 12 was 0.161 L (95% CI: 0.078, 0.245, p < 0.001). Fluticasone/formoterol also demonstrated superior efficacy against GSK FP (LS mean difference = 0.185 L, 95% CI: 0.102, 0.268, p < 0.001). Results from multiple secondary and tertiary efficacy endpoints assessing lung function, asthma symptoms, exacerbations and rescue medication use supported a superior efficacy of the fluticasone/formoterol combination over both fluticasone formulations. Treatment-emergent adverse events were lowest in the fluticasone/formoterol group (32.9%) compared to SKP FP (39.7%) or GSK FP (40.4%). Conclusions: Results from this study demonstrate that fluticasone/formoterol 250/10 μg b.i.d. provides superior efficacy compared to fluticasone alone for the management of moderate-to-severe asthma, with a safety profile similar to that of fluticasone monotherapy. © 2013 All rights reserved.
Dissanayake S.,Mundipharma Research Ltd |
Grothe B.,Mundipharma Research Ltd |
Respiratory Medicine | Year: 2012
International asthma management guidelines recommend a long-acting β2-agonist (LABA) as add-on therapy in patients whose asthma is not controlled by low-dose inhaled corticosteroid (ICS) monotherapy. Treatment with a single inhaler containing an ICS/LABA combination is advocated because it may facilitate adherence to a regimen. When prescribing ICS/LABA combination therapy, the potency of the ICS and the speed of onset of the LABA are considered important factors; therefore, an inhaled therapy containing components with these properties may be valued by physicians. The ICS fluticasone propionate (fluticasone) has potent and sustained anti-inflammatory effects, and the LABA formoterol fumarate (formoterol) provides rapid bronchodilation; the efficacy and safety profiles of these agents have been well established in clinical practice. Fluticasone and formoterol have been combined, for the first time, in a single hydrofluoroalkane-based aerosol (flutiform®; fluticasone propionate/formoterol fumarate). Here, we review data from the published randomized, controlled, clinical trials that demonstrate the efficacy and tolerability of this product. It has been shown that fluticasone/formoterol is more efficacious than fluticasone or formoterol given alone, and provides similar improvements in lung function to fluticasone and formoterol administered concurrently via separate inhalers. Fluticasone/ formoterol has similar efficacy and tolerability profiles to budesonide/formoterol and fluticasone/salmeterol, but with the additional benefit of more rapid bronchodilation than fluticasone/salmeterol. © 2012 Elsevier Ltd. All rights reserved.
SkyePharma | Date: 2010-09-15
Disclosed is a pharmaceutically acceptable oral dosage form comprising fenofibrate, phospholipid, a buffer salt, a water-soluble bulking agent selected from maltodextrin, mannitol, and combinations thereof, a cellulosic additive, beads or crystals of a pharmaceutically acceptable water-soluble excipient support material, a polyvinylpyrrolidone or crospovidone, croscarmellose sodium, granular mannitol, sodium dodecyl sulfate, silicon dioxide, and a stearate, wherein the fenofibrate is in the form of microparticles, and wherein at least a portion of phospholipid is coated on the surfaces of the fenofibrate microparticles, the phospholipid coated microparticles arc embedded in a matrix comprising the water-soluble bulking agent, phospholipid that is not coated on the microparticles, the buffer salt and the cellulosic additive, and the matrix is coated on up to 100% of the surfaces of the beads or crystals of the excipient support material.
News Article | July 27, 2015
DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/lr9n9f/leptomeningeal) has announced the addition of the "Leptomeningeal Disease (Neoplastic Meningitis, Leptomeningeal Carcinomatosis) Global Clinical Trials Review, H1, 2015" report to their offering. "Leptomeningeal Disease (Neoplastic Meningitis, Leptomeningeal Carcinomatosis) Global Clinical Trials Review, H1, 2015" provides data on the Leptomeningeal Disease (Neoplastic Meningitis, Leptomeningeal Carcinomatosis) clinical trial scenario. This report provides elemental information and data relating to the clinical trials on Leptomeningeal Disease (Neoplastic Meningitis, Leptomeningeal Carcinomatosis). It includes an overview of the trial numbers and their recruitment status as per the site of trial conduction across the globe. The databook offers a preliminary coverage of disease clinical trials by their phase, trial status, prominence of the sponsors and also provides briefing pertaining to the number of trials for the key drugs for treating Leptomeningeal Disease (Neoplastic Meningitis, Leptomeningeal Carcinomatosis).