Open Randomized Low Interventional Clinical Trial to Compare Efficiency in Control Symptoms Between Fluticasone Propionate/Formoterol K-haler (Medium Strength) vs High Strength ICS/LABA in the Treatment of Patients With Persistent Asthma

Clinical trial to demonstrate whether, in patients with moderate asthma, to treat with IC / LABA a medium dose, but not controlled, to achieve a similar degree of control by making a progressive increase of that treatment (CI / LABA a high dose) versus switching to fluticasone / Formoterol K-Haler at medium dose, under conditions of usual clinical practice.

开始日期2020-06-11

申办/合作机构

Mundipharma Pharmaceuticals SL

[+2]

NCT03256903 / Completed临床3期

Open Randomized Clinical Trial to Compare Pain Relief Between Methoxyflurane and Standard of Care for Treating Patients With Trauma Pain in Spanish Emergency Units.

Clinical trial to compare pain relief between methoxyflurane and any analgesic treatment used in usual clinical practice, in patients with trauma and associated pain, treated in Spanish emergency units.

开始日期2017-07-07

申办/合作机构

Mundipharma Pharmaceuticals SL

100 项与 Mundipharma Pharmaceuticals SL 相关的临床结果

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

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项与 Mundipharma Pharmaceuticals SL 相关的文献（医药）

2017-01-01·Advances in Therapy3区 · 医学

Association of Performance Status and Pain in Metastatic Bone Pain Management in the Spanish Clinical Setting

3区 · 医学

Article

作者: Esteban González, Emilio ; Cantos Sánchez de Ibargüen, Blanca ; Trujillo Vílchez, Rafael ; Zugazabeitia Olabarría, Luis ; Peláez Fernández, Ignacio ; Capdevila Castillón, Jaume ; Poza de Celis, Raúl ; Traseira Lugilde, Susana ; Dómine Gómez, Manuel ; Díaz Fernández, Nieves ; Martínez Lozano, Joaquina

INTRODUCTIONBone metastasis is the most common cause of cancer-related pain, and metastatic bone pain (MBP) is not only severe but also progressive in many patients. The aim of this study was to investigate the association between pain management and performance status in patients with metastatic bone cancer in the Spanish clinical setting.METHODSA 3-month follow-up prospective, epidemiologic, multicenter study was conducted in 579 patients to assess the evolution of their performance, the impact of pain control on sleep and functionality, and the degree of pain control according to analgesic treatment.RESULTSIn patients with MBP, Eastern Cooperative Oncology Group (ECOG) status (1.5 ± 0.7-1.3 ± 0.7 and 1.3 ± 0.8; p < 0.001) and pain (6.5 ± 1.4-2.8 ± 1.9 and 2.1 ± 1.9; p < 0.001) improved significantly from baseline to months 1 and 3, as did functionality and sleep, after a treatment change consisting of increasing the administration of opioids. Evolution of ECOG and pain were closely related. ECOG and pain outcomes were significantly more favorable in patients treated with opioids versus non-opioid treatment, and in patients who did not need rescue medication versus those who did.CONCLUSIONSMBP is currently poorly managed in Spain. ECOG improvement is closely and directly related to pain management in MBP. Opioid treatment and a lack of requirements for rescue medication are associated with better ECOG and pain outcomes in MBP patients.FUNDINGMundipharma Pharmaceuticals S.L.

PLOS ONE3区 · 综合性期刊

An exploratory, large-scale study of pain and quality of life outcomes in cancer patients with moderate or severe pain, and variables predicting improvement

3区 · 综合性期刊

ArticleOA

作者: Traseira, Susana ; López, Iker ; Núñez, Miguel A ; Zugazabeitia, Luis ; Martí-Ciriquián, Juan L ; Maximiano, Constanza ; Provencio, Mariano ; Martín, Cristina ; Contreras, Jorge ; Herdman, Michael

BACKGROUNDThere have been few large-scale, real world studies in Spain to assess change in pain and quality of life (QOL) outcomes in cancer patients with moderate to severe pain. This study aimed to assess changes on both outcomes after 3 months of usual care and to investigate factors associated with change in QoL.PATIENTS AND METHODSLarge, multi-centre, observational study in patients with lung, head and neck, colorectal or breast cancer experiencing a first episode of moderate to severe pain while attending one of the participating centres. QoL was assessed using the EuroQol-5D questionnaire and pain using the Brief Pain Inventory (BPI). Instruments were administered at baseline and after 3 months of follow up. Multivariate analyses were used to assess the impact of treatment factors, demographic and clinical variables, pain and other symptoms on QoL scores.RESULTS1711 patients were included for analysis. After 3 months of usual care, a significant improvement was observed in pain and QoL in all four cancer groups (p<0.001). Effect sizes were medium to large on the BPI and EQ-5D Index and Visual Analogue Scale (VAS). Improvements were seen on the majority of EQ-5D dimensions in all patient groups, though breast cancer patients showed the largest gains. Poorer baseline performance status (ECOG) and the presence of anxiety/depression were associated with significantly poorer QOL outcomes. Improvements in BPI pain scores were associated with improved QoL.CONCLUSIONIn the four cancer types studied, pain and QoL outcomes improved considerably after 3 months of usual care. Improvements in pain made a substantial contribution to QoL gains whilst the presence of anxiety and depression and poor baseline performance status significantly constrained improvement.

Journal of Pain Research3区 · 医学

Low-Dose Methoxyflurane versus Standard of Care Analgesics for Emergency Trauma Pain: A Systematic Review and Meta-Analysis of Pooled Data

3区 · 医学

ArticleOA

作者: Traseira Lugilde, Susana ; Dickerson, Sara ; Fabbri, Andrea ; Caumont-Prim, Aurore ; Montestruc, François ; Ricard-Hibon, Agnes ; Borobia, Alberto M ; Coffey, Frank ; Soldi, Amedeo

PURPOSEUndertreatment of trauma-related pain is common in the pre-hospital and hospital settings owing to barriers to the use of traditional standard of care analgesics. Low-dose methoxyflurane is an inhaled non-opioid analgesic with a rapid onset of pain relief that is approved for emergency relief of moderate-to-severe trauma-related pain in adults. This analysis was performed to compare the efficacy and safety of low-dose methoxyflurane with standard of care analgesics in adults with trauma-related pain.METHODSA meta-analysis was performed on pooled data from randomized controlled trials identified via a systematic review. The primary endpoint was the pain intensity difference between baseline and various time intervals (5, 10, 15, 20, and 30 minutes) after initiation of treatment.RESULTSThe pain intensity difference was statistically superior with low-dose methoxyflurane compared with standard of care analgesics (overall estimated treatment effect=11.88, 95% CI=9.75-14.00; P<0.0001). The superiority of low-dose methoxyflurane was demonstrated at 5 minutes after treatment initiation and was maintained across all timepoints. Significantly more patients treated with methoxyflurane achieved response criteria of pain intensity ≤30 mm on a visual analog scale, and relative reductions in pain intensity of ≥30% and ≥50%, compared with patients who received standard of care analgesics. The median time to pain relief was shorter with methoxyflurane than with standard of care analgesics. The findings were consistent in a subgroup of elderly patients (aged ≥65 years).CONCLUSIONMethoxyflurane can be considered as an alternative to standard of care analgesics in pre-hospital and hospital settings for treatment of adult patients with acute trauma-related pain.

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100 项与 Mundipharma Pharmaceuticals SL 相关的转化医学

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