Buftea, Romania
Patient Blood Management Implementation in CEE Study
The goals of the PBM program: - Improving patient care and optimizing blood management - quality assurance - bleeding management based on latest scientific guidelines including: 1. reduction of transfusion and better outcomes 2. optimization of blood reserves 3. introduction and acceptance of hospital protocols Previous research has identified gaps concerning implementation of PBM elements in CEE region calling for further research and training: anemia is not being managed appropriately, there are no protocols in place, patient journey is not clearly defined, it is not clear at which department should be anemia treated; availability of POC devices varies largely among countries; local protocols for management of severe bleeding are also missing in many hospitals. Investigators plan to collect PBM implementation indicators in hospitals before PBM training at a given start point as baseline (first self audit) and re-evaluate achievements after 6 months after training (second self audit). Investigators plan to define 2x1 week "snapshot" period for detailed analysis of perioperative approach at patient level (1 week at the beginning of the study and 1 week after 6 month). Investigators assume that properly conducted self-audits followed by PBM training, optimizing local protocols and patient journeys, a reduction in the use of perioperative blood products may be achieved, which, in addition to the currently experienced decrease in the desire to donate blood, may lead to a more rational blood product management and better patient outcomes. PBM Implementation indicators for hospitals (data to be collected): - PBM administration & training data - are there PBM managers/local protocols available? was there any PBM training of staff performed? - Pilar I.: data about diagnosis and management of anemia; patient pathways; medications used to treat anemia - Pilar II.: blood saving techniques; usage of blood products (transfusion) and/or factor concentrates; iatrogenic blood loss - lab test tubes size - Pilar III.: RBC tranfusion triggers; Patient level data: - age, gender, type of surgical intervention - data about anemia management (performed or not by whom, when and what treatment was received if any - data about existing anticoagulant therapy an management - data about bleeding management (blood loss, transfusion requirements, factor concentrates (used quantities per routine medical intervention), POC tests evaluations if any, and standard laboratory test performed per routine medical approach before, during and after surgery - data about postoperative outcomes
Phase
N/ASpan
84 weeksSponsor
Semmelweis UniversityBudapest
Recruiting
The Effect of Different Risk Factors on the Success Rate of VPT
Objectives: The primary objective of this study is to explore the effectiveness of different VPT methods after pulp exposure. A secondary objective is to establish the relationship between success rate, age and other co-factors. Study methodology: We plan a single-centre, three-arm, observational prospective cohort study. The study will be organised and hosted by the Department of Restorative Dentistry and Endodontics, Semmelweis University. Patients for the study will be selected from patients presenting at the ambulance of the Semmelweis University Department of Restorative Dentistry and Endodontics. For patients who meet the inclusion criteria, we record the patient's baseline clinical data Baseline data, as well as information obtained during the study and findings during follow-up (7 days, 6 months, 1 year, 2 years, 3 years, 4 years) are recorded by the interventionalist in an online database (REDCap). Interventions are carried out according to the following steps: After local anaesthesia (Lidocaine-adrenaline 20 mg/0.01 mg/ml, Egis, Budapest, Hungary) and mouth rinsing with 0.2% chlorhexidine, the tooth is absolutely isolated using a rubber dam and liquid dam (Opaldam- Ultradent, South-Jordan, Utah). The coronal part of the tooth is then disinfected with a cotton pellet soaked in 5% sodium hypochlorite (NaOCl). Under an operating microscope, the caries is removed non-selectively, first with a diamond bur under water cooling, then with a steel bur inserted in a handpiece, moving from the periphery of the tooth towards the pulpal wall. The absence of caries on non-pulpal walls is confirmed by caries indicator (Sable Seek-Ultradent, South-Jordan, Utah). The pulp chamber is opened with a sterile diamond bur in a turbine with copious water cooling. After opening the pulp, different types of treatment are used depending on the extent of inflammation and caries. 1. Direct pulp capping: Pressure of a sterile cotton pellet soaked in 2.5% NaOCl is applied to the exposed pulp to achieve hemostasis. After the bleeding has stopped, the cavity is flushed with sterile saline and Biodentine (Septodont, Saint-Maur-des-Fossés, France) or MTA is mixed according to the manufacturer's instructions. The patient is called back after 1 week, when the temporary restoration is removed and a final restoration is placed in the cavity, which may be a composite filling, inlay or crown, depending on the amount of remaining tooth material. This type of intervention is performed (1) if a healthy tooth with a normal pulp has suffered iatrogenic pulp exposure and the pulp tissue is surrounded by intact dentin tissue, and (2) when it is asymptomatic, or with reversible pulpitis symptoms after extra deep caries removal, there is no dentin chips are the pulp tissue, it is surrounded by healthy dentin, there is no evidence of necrosis in the pulp, and bleeding can be controlled within 5 minutes with a cotton pellet soaked in 2.5% NaOCl. Direct pulp capping will berejected if the patient has spontaneous pain before treatment, bleeding from the pulp is not controllable within 5 minutes, necrotic tissue is present in the pulp chamber, or if the pulp is explose through carious dentin. 2. Partial pulpotomy After opening of the pulp with a sterile diamond bur, an additional 2-3 mm of coronal pulp tissue is removed with copious water cooling. Subsequently, light pressure is applied to the pulp for 5 minutes with a cotton pellet dipped in 2.5% NaOCl to control bleeding. After controlling the bleeding, the cavity is flushed with sterile saline and Biodentine or MTA is applied the same way as in case of direct pulp capping. Partial pulpotomy is the treatment of choice in the following clinical situations: (1) in case of extra-deep caries the bacterial biofilm and infected dentin can be only removed by superficial pulp excision, (2) when further caries removal is required after pulp exposure due to the risk of infected dentin shavings entering the pulp, (3) in the case of normal pulp after extra-deep caries removal, bleeding cannot be controlled within 5 minutes after direct pulp capping attempt, (4) in the case of reversible pulpitis, if bleeding cannot be stopped within 5 minutes after pulp exposure. We exclude from partial pulpotomy treatment, for any of the above indications, cases where bleeding cannot be stopped within 5 minutes. 3. Complete pulpotomy During a total coronal pulpotomy, the coronal pulp tissue is removed down to the level of the orifices using a sterile diamond bur with copious water cooling. Bleeding is controlled by gentle pressure with a cotton pellet soaked in 2.5% NaOCl. When the bleeding stops, the cavity is flushed with sterile saline and Biodentine or MTA is applied the same way as in case of direct pulp capping. Complete pulpotomy is the treatment type of choice in the following clinical situations: (1) reversible pulpitis/normal pulp with anemic necrotic tissue in the pulp, (2) reversible pulpitis, normal pulp after partial pulpotomy if bleeding cannot be controlled in 5 minutes, (3) if the patient's complaints include spontaneous or persistent pain/night pain. Exclusion criteria for complete pulpotomy treatment include (1) bleeding uncontrollable in 5 minutes, or (2) anaemic/necrotic tissue at the level of the orifices. The patients will be consulted about any complaints or changes in complaints 7 days after the procedure, at the same time as the final restoration is made. If there are no previous complaints, the patient will be referred back for a follow-up examination six months after the procedure. Then, after recording any complaints, a control radiograph and clinical examination (inspection, palpation, palpation, periodontal pocket probing) are performed. The same is repeated 1 year, 2 years, 3 years and 4 years after treatment. Evaluation of the results: The success of the treatment is evaluated by combining the patient's subjective complaints with the results of the clinical examination and periapical radiograph. The periapical index (PAI) is used to assess the periapical space on radiographs.
Phase
N/ASpan
313 weeksSponsor
Semmelweis UniversityBudapest
Recruiting
A Stepped Wedge Cluster Randomised Trial of Video Versus Direct Laryngoscopy for Intubation of Newborn Infants
INTRODUCTION Many newborn infants have difficulty breathing after birth. Some of these babies have a tube inserted into their "windpipe" (trachea) - an endotracheal tube (ETT) - through which they are given breathing support (ventilation). When clinicians attempt to intubate (insert an ETT), they use an instrument called a laryngoscope to view the airway in order to identify the entrance to the trachea (larynx). Standard laryngoscopes have a "blade" (which, despite its name, is not sharp) with a light at the tip. Doctors insert the blade into the baby's mouth to view the larynx. Traditionally, clinicians used a standard laryngoscope to look directly into the baby's mouth to view the larynx (direct laryngoscopy, DL). When clinicians attempt to intubate newborns with DL, less than half of first attempts are successful. Also adverse effects - such as falls in the blood oxygen levels (fall in oxygen saturation (SpO2), or "desaturation"), slowing down of the heart rate (bradycardia), oral trauma - are relatively common. In recent years, video laryngoscopes (VL) have been developed. In addition to a light, VL have a video camera at the tip of the blade. This camera acquires a view of the larynx and displays it on a screen that the clinician views when attempting intubation (indirect laryngoscopy). In a randomised study performed at the National Maternity Hospital, Dublin, Ireland, more infants were successfully intubated at the first attempt when clinicians used VL compared to DL [79/107 (74%) versus 48/107 (45%), P<0.001]. While this study was large enough to show that VL resulted infants being successfully intubated at the first attempt in one hospital, it couldn't give information about how it might work in a range of hospitals, and it wasn't large enough to see what effect VL had on adverse events. There is a large difference in cost between a standard laryngoscope (approx. €300) and a video laryngoscope (approx. €21,000). This is a matter of concern for all hospitals, particularly in settings where resources are more limited. The investigators aim to assess whether VL compared to DL results in more infants being intubated at the first attempt without physiological instability. STUDY DESIGN A recent single centre study reported that that more newborn infants were successfully intubated at the first attempt when VL was used to indirectly view the airway compared to DL. This study was not large enough to determine the effect of VL on adverse effects that are seen commonly (e.g. desaturation) or more rarely (e.g. bradycardia, receipt of chest compressions or adrenaline, oral trauma) during intubation attempts. For the current study, the investigators chose a stepped-wedge cluster randomised controlled design, where the participating centre, rather than the individual infant, will be the unit of randomisation. This design has been found appropriate to test the effects of an intervention that encompasses a behavioural aspect and to implement interventions while studying them at the same time. In this study, all centres will begin in the "control group"; where clinicians will routinely attempt intubation with DL, as is their usual practice. At specified intervals, centres will be randomly assigned to cross over to the "intervention group", where clinicians will routinely attempt intubation with VL. All participating centers will have included patients in both arms by the end of the study. SAMPLE SIZE ESTIMATION To determine the intra-cluster correlation (that means the correlation between two observations from the same centre), the investigators used the dataset of the MONITOR trial that included infants from 7 delivery rooms worldwide. In this trial, the intra-cluster correlation for intubation in the delivery room was reported as 0.1. This complete stepped-wedge cluster-randomized design includes 21 time periods (including the baseline) and 20 centres that will be including patients, with each randomised to a unique sequence. Each time period lasts a fortnight. Each time period, 1 centre will switch their treatment from DL to VL. With all centres including 2 patients each time period, 42 patients will be included per centre which will provide a total sample size of 840 patients. Assuming a control proportion of 0.4, this sample will achieve 90% power (0.9091) to detect a treatment proportion of 0.55, assuming a conservative ICC of 0.05. The power is not very sensitive to ICC values up to 0.1 (power of >90% to detect difference 40% versus 56%). The test statistic used is the two-sided Wald Z-Test. TREATMENT OF SUBJECTS DIRECT LARYNGOSCOPY (DL, control period) At the start of the study, clinicians at participating centres will attempt intubation using a standard laryngoscope to perform DL as is their normal practice. VIDEO LARYNGOSCOPY (VL, intervention period) For each centre, a lot will be drawn which indicates the month in which endotracheal intubation will be routinely attempted with VL rather than DL. In the month before the switch, centres will be provided with a C-MAC VL by the manufacturers, Karl Storz-Endoskop (Tuttlingen, Germany). The system will be provided on loan for the duration of the study and will consist of an 8" high-definition monitor with connecting cable and reusable straight Miller type blades size 0 and size 1. The equipment will be demonstrated by representatives from Karl Storz, and clinicians who intubate babies at participating hospitals will be encouraged to practice with the equipment on mannequins. We will have an virtual meeting with each centre in the week before they are due to switch to review the protocol, data collection and to answer any queries that they may have. All other procedures in the delivery room and NICU will be performed according to international and local guidelines. All other aspects of the approach to intubation at the participating centre are at the discretion of the local clinicians and should remain the same for the duration of the study; e.g.: - The drugs used before intubation attempts (e.g. opiate, atropine, curare-like drug) - The route by which intubation is usually attempted (i.e. oral or nasal) - Whether they use a stylet is routinely used - Whether supplemental oxygen is given during attempts
Phase
N/ASpan
51 weeksSponsor
University College DublinBudapest
Recruiting
A Prospective Observational Study of Video Laryngoscopy Versus Direct Laryngoscopy for Insertion of a Thin Endotracheal Catheter for Surfactant Administration in Newborn Infants
Many newborn infants have breathing difficulty after birth, particularly when they are born prematurely. Many of these infants are supported with nasal continuous positive airway pressure (NCPAP). Some of the infants deteriorate despite treatment with NCPAP and have a thin catheter inserted into their trachea for the administration of surfactant, which is then immediately removed (often referred to as "less-invasive surfactant administration" or LISA). Insertion of a thin catheter is usually performed by doctors who are experienced at intubation (i.e. inserting endotracheal tubes, ETTs). They look directly into the the infants mouth using a standard laryngoscope to identify the opening of the airway (i.e. perform direct laryngoscopy). More recently video laryngoscopes have been developed. These devices display a magnified image of the airway on a screen that can be viewed indirectly by the doctor attempting to insert the ETT or thin catheter, and also by others. A single centre study reported that more infants were successfully intubated at the first attempt when doctors performed indirect video laryngoscopy compared to direct laryngoscopy. It is possible to independently verify when a doctor has correctly inserted and ETT, for example by detecting carbon dioxide coming out of the tube or seeing condensation in the tube during exhalation, or by hearing breath sounds by listening to the chest during positive pressure inflations. It is not possible to independently verify whether a doctor has correctly inserted a thin catheter under direct laryngoscopy, by these or other means. The standard (and to date only) way of confirming that a thin catheter has been correctly inserted is to rely on the report of the operator. Video laryngoscopy, in contrast, allows the independent verification of the tip of a thin catheter by one or more people observing the screen. The investigators are performing NEU-VODE, a stepped wedge cluster randomised study of the introduction of video laryngoscopy versus direct laryngoscopy for the intubation of newborn infants. Alongside this study, the investigators are performing a study of infants who have a thin endotracheal catheter inserted under video laryngoscopy versus direct laryngoscopy. As it is not possible to measure the outcome of successful insertion of the thin catheter equally in both groups, this is a prospective observational cohort study. The investigators will record information on infants who have a thin catheter inserted into the trachea for the purpose of surfactant administration at centres participating in the NEU-VODE study. The type of laryngoscope used for thin catheter insertion attempts will not be mandated; instead, the investigators will compare the information of groups within the cohort who have their first attempt made using the video laryngoscope to the group who have their first attempt made with direct laryngoscopy.
Phase
N/ASpan
51 weeksSponsor
University College DublinBudapest
Recruiting
Prospective, Multicenter, Single-Arm Observational Study to Confirm the Safety and Clinical Performance of the Oscar Peripheral Multifunctional Catheter for the Dilatation of Lesions in the Femoral, Popliteal and Infrapopliteal Arteries (BIO-OSCAR First)
This is a prospective, multicenter, all-comers observational study. Primary endpoint was procedural success (defined as a combination of successful primary target lesion crossing, residual stenosis of ≤30% following vessel preparation and before definite treatment) and absence of procedural complications (defined as target vessel perforation or rupture, acute occlusion, and distal embolization).
Phase
N/ASpan
57 weeksSponsor
Biotronik AGBudapest
Recruiting
The Success of Implant-borne Prostheses Following Fully-guided Static Computer-assisted Implant Surgery.
Surgical planning A virtual planning software is used for surgical planning. Cone beam computed tomography (CBCT) reconstruction and intraoral scans are registered. Prosthetic plans are created in the software, or the radiological template was used as one. The angulation and position of the dental implants are determined by the prosthetic plan. Surgical guides The surgical templates are manufactured by rapid prototyping (3D printing). To guide the drills for implant bed preparation sleeves are inserted in the surgical guides. Surgical protocol Surgical interventions are performed by a single clinician experienced in dental implant placement and static navigation. Patients rinse with 0.2% chlorhexidine solution for 1 min before surgery. The fit of the surgical guide is checked under local anesthesia. Fully guided implant bed preparation is performed. Dental implants are placed non-submerged. Sutures are removed at 7 days postop. The prosthetic stages of treatment begin after a two-month healing period. Prosthetic procedures Implant-borne overdentures are manufactured using a hybrid (analog-digital) workflow. An open tray impression is taken using a medium body silicone impression material to capture the position of the implant platforms. An overdenture and a bar mesostructure are manufactured by the dental laboratory with a precision attachment. Fixed partial dentures (FPD) are manufactured using either a hybrid or a digital workflow. An open tray impression is taken using a medium body silicone impression material or postoperative intraoral scans are performed with scan bodies to capture the position of the implant platforms. Screw or cement-retained porcelain fused to metal FDPs are manufactured by the dental laboratory. Pre-contacts are finished using articulating papers until balanced occlusion in cases of overdentures or lateral guidance in cases of FPDs are obtained. Patients are recalled twice per year for controls and professional dental hygiene intervention.
Phase
N/ASpan
17 weeksSponsor
Semmelweis UniversityBudapest
Recruiting
A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer
The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm. This study will be conducted at up to 200-250 sites globally in approximately 25 countries.
Phase
3Span
298 weeksSponsor
AstraZenecaBudapest
Recruiting
Semmelweis Esophageal Cancer Study: Noninvasive Prognostic Parameters in Patients With Oesophageal and Esophagogastric Junction Cancer
Detailed assessment of the baseline cardiovascular risk and status (anthropometric data, physical status assessment, psychological and quality-of-life questionnaire, questionnaires on morbidity and cancer-related fatigue, 12-lead ECG, laboratory parameters, body composition, coronary CT, echocardiography and cardiac MR scan). In addition to the conventional echocardiographic and cardiac MR parameters, the investigators also aimed to determine myocardial deformation, i.e. strain (Medis Suite QStrain) and T1 and T2 mapping values and late-type contrast enhancement and to investigate their prognostic role. To determine late-type contrast accumulation and to determine ECV (extracellular volume), patients will be given Gadovis contrast media. At the same time as the cardiac MR scan (V0 and V4), a serum blood sample will be taken from the patients, from which the markers below will be measured. These markers are proteins or molecules that potentially play an important role in the development of tumour cachexia. The investigators aim to determine the prognostic significance of these parameters. (Myostatin, IGF-1 (Insulin-like Growth Factor 1), GDF-15 (Growth Differentiation Factor 15), IL-6 (Interleukin-6). Patients are followed up for cardiovascular complications during anti-tumour treatment and are taken into care. Patients will be assessed at first presentation, after neoadjuvant treatment, immediately before surgery, in the third week after surgery and in the 3rd, 6th, 9th, 12th postoperative months. Further follow-up is done by outpatient examination, by telephone or e-mail and through the eHealth system of Hungary (EESZT) until the end of the 3rd year. Patient education: The detailed patient information leaflet was prepared by the doctors involved in the development of the protocol at Semmelweis University. Data storage and data protection: Patients enrolled in the study will be given a unique identifier after enrolment. Only this unique identifier will be used in the research record, so the record will not be directly linked to the patient. No unique identifier (name, place and date of birth, clinical triage number, social security number, ID card number, etc.) will be included in the research form. A separate, locked document will be used to link the unique identifier to the patient. The system-generated unique identifier code is recorded by the clinician on paper, complete with name, social security number and patient´s social security number, prior to the first data entry. The same document contains the patient´s informed consent for the use of the data for scientific purposes. The database and the information and consent forms, including the patient´s signature, are stored by the institute coordinators. Statistical methods: Using TIBCO Statistica™ 13.4 software, the normality of continuous variables is tested using the Kolmogorov-Szmirnov test. A two-sample t-test is used for normal distribution assuming a two-tailed distribution and a one-tailed distribution for selected variables (Mandard Score for tumour regression). For variables with non-normal distribution, a Mann-Whitney U test is used as a non-parametric test. Long-term survival data are analysed using Kaplan-Meyer analysis and log rank test.The level of significance is set at p<0.05 Ethical requirements The research design was drawn up in accordance with current legislation and the World Medical Assotiation´s Declaration of Helsinki.
Phase
N/ASpan
522 weeksSponsor
Semmelweis UniversityBudapest
Recruiting
Intranasal Breast Milk Therapy in HIE
Perinatal asphyxia and the resulting hypoxic-ischemic encephalopathy (HIE) are the leading cause of neonatal mortality and long-term neurodevelopmental disabilities. Based on our current knowledge, therapeutic hypothermia is the only therapy that has been proven to reduce central nervous system damage in HIE neonates. Improving neurodevelopmental outcomes of newborns with HIE has been an intense area of research over the past decade. Breast milk is a complex biological substance that contains a variety of bioactive components including neurotrophic growth factors, cytokines, immunoglobulins, and multipotent stem cells. Studies have shown that exclusive breastfeeding in the early stages of development has a positive impact on cognitive outcomes. Animal studies support that mesenchymal stem cells and neurotrophic substances found in breast milk, when administered intranasally enter the central nervous system and reduce the extent of neurological damage. In preterm infants, it has been shown that intranasally administered breast milk is safe and well-tolerated. In this open-label prospective randomized controlled single-center interventional study, the objective is to administer fresh, own-mother's breast milk intranasally to neonates with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, starting from the first day of life and continuing for 28 days. The primary objective is to compare neurodevelopmental outcomes between the control group and the intervention group receiving intranasal breast milk treatment. The secondary objective is to compare the progression of enteral feeding and the duration of exclusive breastfeeding between the intervention and the control group.
Phase
1Span
309 weeksSponsor
Semmelweis UniversityBudapest
Recruiting
Investigation of Fixed Triple Inhaled Combination in Asthmatic Patients, in a Real-life Setting
Study design Multicentre, national, non-interventional, prospective study evaluating the effectiveness of Trimbow 172/5/9 μg pMDI on symptom scores in 6 months after switch from previous LABA-high dose ICS containing treatment in asthmatics. Dosage regimen and administration Name of the product: Trimbow 172 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution (henceforth abbreviated as Trimbow 172/5/9 μg pMDI). Each delivered dose (the dose leaving the mouthpiece) contains 172 μg of beclometasone dipropionate, 5 μg of formoterol fumarate dihydrate and 9 μg of glycopyrronium (as 11 μg glycopyrronium bromide). Each metered dose (the dose leaving the valve) contains 200 μg of beclometasone dipropionate, 6 μg of formoterol fumarate dihydrate and 10 μg of glycopyrronium (as 12.5 μg glycopyrronium bromide). The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily. 1. Aim of the study (research objective) Primary objective: The main objective is to assess the effectiveness of BDP/FF/G 172/5/9 μg fixed triple combination in a real-world setting, with regards to improvements in symptom scores (ACT). 2. Test sample and method, recruitment principle No patient recruitment will be performed. Eligible patients will be enrolled during the participating physicians' regular asthma patient management and patients' written informed consent. Patient inclusion will take place among patients having severe asthma and attending pulmonology outpatient clinics (the chosen study sites are attached as annexes to the study protocol), strictly at the time of the patients' visit. The planned number of patients is 800. 3. Structure of the study In accordance with the requirements of non-interventional studies, the assignment of patients to Trimbow 172/5/9 μg pMDI therapy should be made independently of the study, and patients should only be considered for inclusion in the study after a prior therapeutic decision has been made by a pulmonologist. Patient enrolment can take place after the patient has been fully informed about the purpose of the study and all of its details, and the patient has read and signed the patient information leaflet and patient consent form, including any questions they may have. Once this has taken place, the data that would have been generated anyway during the outpatient examination of the patient in accordance with daily practice can be recorded. This is considered the first visit of the study (Visit 1). During this visit, the patient's main demographic data, information on comorbidities and concomitant medications, previous and current asthma therapies, asthma specific assessment (including ACT), exacerbation history, post-dose lung function values (if spirometry data is available), laboratory results (if a laboratory test is performed during the visit or was performed recently), results of other medical examinations (e.g., chest X-ray) if performed regardless of the study, maintenance and reliever inhaled & non-inhaled therapies (former and new) baseline quality of life based on the asthma quality of life (EQ-5D-5L) questionnaire, and adherence to therapy based on Test of Adherence to Inhalers® (TAI-12) questionnaire are recorded. Patients will then attend two additional visits 30 days and 6 months after enrolment as per routine clinical practice (Visits 2 and 3). During these visits, data will also be recorded, once again, according to routine clinical practice. Assessing the usage of rescue medications and patient adherence are also planned with the use of electronic health record system (EESZT)-verified prescription dispensations (optional for investigators). Visit 4 will be a long-term follow-up to assess the exploratory endpoint of exacerbations rates. If the patient's maintenance therapy changes during the study as decided by the treating pulmonologist, and the patient is no longer receiving Trimbow 172/5/9 μg pMDI, the patient will be automatically excluded from this NIS. The fact of the therapy modification and its exact date must be recorded on the "current medication" form in the eCRF (electronic Case Report Form) of the next visit. If the change in therapy is related to a suspected adverse reaction, it should be reported separately on the eCRF platform in accordance with section 9 of this protocol ('Collection, recording and reporting of medication safety data'). This NIS is open to all eligible patients according to the inclusion and exclusion criteria. Permitted concomitant treatments: allowed all medications according to local clinical practice (any non-inhalation therapy for asthma or other diseases) and reliever (short-acting bronchodilators) inhaled therapies for asthma. The data to be recorded will be detailed in the study data sheet that forms part of the protocol. The data is recorded in the eCRF (MrAgent - Medisol Development Ltd., see also at 10.1.) system, with consideration to the current professional and legal regulations. 4. Start and duration of the study The first patient enrolment will take place after receiving approval from the National Public Health Center (NPHC), based on a beneficial assessment of the Medical Research Council of Hungary. The study is planned to start on September 16, 2024. Accordingly, first patient first visit (FPFV) is also planned to take place in September, 2024. The launch of the participating centres is planned in two waves, in the autumn of 2024 and in the spring of 2025. Each centre will have 12 months to enrol patients. After the last visit of the last patient (LPLV), centres will have one month to collect all missing data / correct any data flagged as queries during monitoring. Thus, the LPLV will take place on Oct 31, 2026 (primary endpoint) and 30 April, 2027 (exploratory endpoint), respectively. The study is planned to be concluded on August 31, 2027. 5. Data to be recorded during the visits A total of 4 visits will be performed for the assessment of the primary and secondary endpoints during the study. The table below summarises the data collection to be carried out during the visits separately. The patient may be enrolled in the study and their data may only be recorded, if these data would also have been recorded in accordance with standard medical practice. - Visit 1: Time of enrolment - a normal visit, according to routine clinical practice. Informed consent and baseline patient characteristics will be collected. - Visit 2: 1 month after enrolment (± 2-3 workdays) - Visit 3: 6 months after enrolment (± 5-7 workdays) - Visit 4: 12 months after enrolment (± 10-15 days)
Phase
N/ASpan
149 weeksSponsor
Chiesi Hungary Ltd.Budapest
Recruiting