Open randomized clinical trial to compare pain relief between low-dose methoxyflurane and standard of care for the treatment of patients with trauma pain in emergency medical services in the Netherlands. - Low-dose MEOF vs SoC for trauma pain in emergency medical services

开始日期2019-07-08

申办/合作机构

Mundipharma Pharmaceuticals BV

NCT02811315 / WithdrawnN/A

Flutiform Treatment in Patients With Asthma in Daily Clinical Practice; a Prospective Observational Non-interventional Study Assessing the Effect of Space Use and Adherence on Fluticasone/Formoterol FDC Efficacy Measured With the Asthma Control Questionnaire (ACQ-6).

The objective of the study is to evaluate the effect of frequency of use with a spacer on asthma control in Dutch patients with asthma during their daily clinical practice over 12 weeks treatment.

开始日期2016-07-01

申办/合作机构

Mundipharma Pharmaceuticals BV

EUCTR2014-004904-31-NL / Unknown status临床4期

An open-label, multicentre, phase IV study to investigate the infliximab serum concentration of Remsima™ (infliximab biosimilar) after switching from Remicade (infliximab) in subjects with Crohn’s Disease (CD), Ulcerative Colitis (UC) or Rheumatoid Arthritis (RA) in stable remission.

开始日期2015-05-19

申办/合作机构

Mundipharma Pharmaceuticals BV

100 项与 Mundipharma Pharmaceuticals BV 相关的临床结果

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0 项与 Mundipharma Pharmaceuticals BV 相关的专利（医药）

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项与 Mundipharma Pharmaceuticals BV 相关的文献（医药）

2022-07-01·Crohn's & Colitis 360

Switching From Reference Infliximab to Biosimilar CT-P13 Did Not Change Quality of Life in Stable Inflammatory Bowel Disease Patients

Article

作者: van der Meulen, Andrea E ; Van der Linde, Klaas ; Sikkens, Michelle S G ; Pierik, Marieke J ; Kuijvenhoven, Johan P ; Stoop, Corinne M ; Klompmaker, Ids J ; Dijkstra, Gerard ; Akol, Halil ; Lutgens, Maurice ; Bloemsaat-Minekus, Joanne P J ; van Megen, Yvonne J B

AbstractBackgroundQuality of life (QoL) data for patients with inflammatory bowel disease switched from the reference infliximab to biosimilar CT-P13 is lacking. This study aims to demonstrate noninferiority for QoL and efficacy after switching.MethodsOoL and clinical efficacy were measured prior to and after 2, 4, and 6 CT-P13 infusions.ResultsOne hundred seventy-eight patients were included. Noninferiority was established for QoL [ratio 97.95% (95% confidence interval 95.93 to 100.01)] and efficacy [difference −0.02 (95% confidence interval −0.68 to 0.64)]. Five patients reported 6 nonrelated, serious adverse events.ConclusionsSwitching from reference infliximab to CT-P13 did not affect the QoL or disease activity and was well tolerated.

2022-04-01·BMJ Open4区 · 医学

Treatment persistence and exacerbations in patients with asthma initiating treatment with inhaled corticosteroids and beta-adrenergic agonists: retrospective cohort study

4区 · 医学

ArticleOA

作者: Velasco Garrido, José Luis ; Traseira-Lugilde, Susana ; Sicras-Mainar, Antoni ; Gómez Rodríguez, Belén ; Fernández-Sánchez, Toni

ObjectiveTo determine treatment persistence and exacerbations in patients initiating inhaler treatment with fixed-dose combinations of inhaled corticosteroids/long-acting beta-2-adrenergic agonists (ICS/LABA) for the treatment of asthma.DesignRetrospective observational study conducted by review of electronic medical records (database: Fundación RediSS).SettingRetrospective cohort study. The follow-up period was 1 year.ParticipantsThe study included patients aged ≥18 years who started treatment with ICS/LABA and met the inclusion/exclusion criteria.Main outcomes and measuresThe study groups were fluticasone propionate/salmeterol (FP/SAL), beclomethasone/formoterol (BDP/FORM), budesonide/formoterol (BUD/FORM), fluticasone furoate/vilanterol (FF/VI) and fluticasone propionate/formoterol (FP/FORM). The main measurements were persistence, medication possession ratio (MPR) and exacerbations. Statistical significance was established as p<0.05.ResultsIn total, 3203 patients were recruited for the study. By groups, 31.1% FP/SAL, 28.6% BDP/FORM, 25.0% BUD/FORM, 8.2% FF/VI and 7.0% FP/FORM. The mean age was 52.2 years, 60.8% were female and 44.9% had persistent-moderate asthma. Treatment persistence was 61.7% (95% CI 60.0% to 63.4%) and by study group it was FP/SAL: 60.7%, BDP/FORM: 61.2%, BUD/FORM: 60.3%, FF/VI: 66.7% and FP/FORM: 67.6% (p=0.046). MPR by study group was FP/SAL: 74.3%, BDP/FORM: 73.8%, BUD/FORM: 74.6%, FF/VI: 79.4% and FP/FORM: 80.6% (p=0.028). The mortality rate was 2.9%. By treatment group, exacerbations were FP/SAL: 21.9% (95% CI 19.3% to 24.5%), BDP/FORM: 22.2% (95% CI 19.5% to 24.9%), BUD/FORM: 22.8% (95% CI 19.9% to 25.7%), FF/VI: 17.9% (95% CI 14.9% to 20.7%) and FP/FORM: 16.0% (95% CI 12.2% to 19.3%), p=0.036.ConclusionsPatients undergoing treatment with FP/FORM and FF/VI versus FP/SAL, BDP/FORM and BUD/FORM were associated with greater treatment adherence (persistence, MPR) and lower rates of exacerbations. However, further studies will be needed to strengthen the consistency of the results.

2021-04-20·Journal of Investigational Allergology and Clinical Immunology3区 · 医学

Factors Affecting the Success of Step-up Therapy in Patients With Moderate-Severe Asthma: A Real-Life Study

3区 · 医学

Article

作者: Delgado, J ; Fernández-Sánchez, T ; Martinez-Moragón, E

Introduction: Clinical practice guidelines recommend regular adjustment of treatment to achieve control of asthma. A step-up approach based on the degree of disease control should be followed. Objective: To perform a real-life analysis of the factors that affect the success or failure of this therapeutic strategy and of the criteria applied by clinicians when applying a step-up approach in a representative sample of patients diagnosed with moderate-severe asthma. Material and Methods: We performed a multicenter retrospective cohort study involving 226 Spanish specialist physicians (98 allergologists, 127 pulmonologists, and 1 family physician). We included 1254 patients (787 women) diagnosed with moderate-severe asthma who underwent step-up therapy during 2016. Results: Step-up was successful in 44% of cases. The factors associated with success were presence of <2 comorbid conditions, lower grade of severity and therapy step before modification, absence of exacerbations during the previous year, fewer daytime/nighttime symptoms, and limitation in activities, as well as type of inhaled corticosteroid/ long-acting β₂-agonist combination after modification, lower body mass index, and higher fractional exhaled nitric oxide. An early increase in the maintenance dose once a lack of control was detected (≤3 months, >3 to ≤6 months, >6 to ≤12 months) was more likely to be successful. Conclusion: The factors that determine whether or not this therapeutic strategy manages to control asthma are time since onset of clinical impairment, previous grade of severity, number of comorbid conditions, previous exacerbations, and frequency of symptoms.

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