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Severe Asthma clinical trials

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NCT ID: NCT04438408 Recruiting - Severe Asthma Clinical Trials

National Survey on Care Pathway and Quality of Life in Patients With Severe Asthma According to Their Phenotype.

2ndsouffle
Start date: September 1, 2020
Phase:
Study type: Observational

The SECOND SOUFFLE survey focuses on aspects of care and quality of life in a period when the landscape of severe asthma is changing in the context of biotherapies. Moreover survey on care pathway and quality of life of the asthmatic severe population according to their phenotype have never been done. It is likely to bring results in a relatively fast time, results that can lead to guide the criteria collected in RAMSES a national severe asthma cohort and future research tracks of this cohort.

NCT ID: NCT04334031 Recruiting - Multiple Sclerosis Clinical Trials

Deployment o the Multidisciplinary Prospective Cohort Imminent

IMMINeNT
Start date: July 20, 2020
Phase: N/A
Study type: Interventional

Immune-mediated inflammatory diseases (IMIDs) most often affect young patients and have high impact on morbidity and mortality with a significant alteration in the quality of life of patients with professional, social and emotional repercussions. Beyond this burden, IMIDs share many common pathophysiological mechanisms and treatments, known as "targeted therapies". Despite progress in this field, much remains to be done in clinical, therapeutic and fundamental research to address the efficacy, resistance and side-effects of treatment. These similarities between IMIDs have led the FHU IMMINeNT to propose the creation of a prospective, multidisciplinary clinical-biological database (IMMINeNT cohort), associated to a biobank, of patients with IMIDs. The main objectives of this database will be to identify new prognostic and therapeutic biomarkers in order to develop new therapeutic targets and biomarkers, to identify prognostic factors and determinants related to the activity, severity and quality of life of patients with IMIDs as well as to the response and tolerance to treatment.

NCT ID: NCT04272463 Completed - Severe Asthma Clinical Trials

ChAracterisation of ItaliaN Severe Uncontrolled Asthmatic patieNts Key Features When Receiving Benralizumab

ANANKE
Start date: March 13, 2020
Phase:
Study type: Observational

This is an observational, Italian multi-center, retrospective cohort study with enrollment visit on patients suffering from severe eosinophilic asthma who started benralizumab in the Sampling Program or as per normal clinical practice in Italy.

NCT ID: NCT04221802 Completed - Severe Asthma Clinical Trials

Patient-reported Outcomes in Real-world Use of Benralizumab in Patients With Severe Eosinophilic Asthma in Belgium

BE-REAL
Start date: December 23, 2019
Phase:
Study type: Observational

This study aims to assess health and quality of life outcomes in patients treated with benralizumab, within a Belgian Real-World setting. To prove the clinical value of benralizumab in a Real-World setting, the study will document the effect of benralizumab within a time frame of 112 weeks after initiation of treatment.

NCT ID: NCT04108962 Withdrawn - Severe Asthma Clinical Trials

Benralizumab in the Treatment of Patients With Severe Asthma With ABPA

Start date: December 23, 2019
Phase: Phase 4
Study type: Interventional

Phase IV, open-label study will evaluate effects of Benralizumab in the treatment of severe asthma in patients with allergic bronchopulmonary aspergillosis

NCT ID: NCT04048343 Completed - Severe Asthma Clinical Trials

Long-term Safety of Tezepelumab in Japanese Subjects With Inadequately Controlled Severe Asthma

NOZOMI
Start date: June 10, 2019
Phase: Phase 3
Study type: Interventional

This is an open-label, single arm study designed to evaluate the safety of tezepelumab administered subcutaneously every 4 weeks in Japanese adult and adolescent subjects with inadequately controlled severe asthma.

NCT ID: NCT04045587 Recruiting - Severe Asthma Clinical Trials

International Severe Asthma Registry: Canadian Cohort

ISAR
Start date: November 6, 2018
Phase:
Study type: Observational [Patient Registry]

The International Severe Asthma Registry is a global initiative looking to ensure that the care of people with severe asthma will continue to improve by collecting detailed information about the health and treatment of as many people with the disease as possible. The study will gather anonymized longitudinal real-life data for participants with severe asthma for five years. The purpose of the registry is to track the progress of participants and determine how well they are responding to treatment. Medical research using data from the registry will give the investigators a better understanding of severe asthma and help the investigators develop and improve the care and treatment for severe asthma participants. The Canadian cohort of the registry will collect information from Canadian participants with severe asthma across seven different sites.

NCT ID: NCT04031261 Completed - Asthma Clinical Trials

National Validation and Sensitivity to Change of the SAQ

Start date: April 10, 2019
Phase:
Study type: Observational

DESIGN A multi-centre mixed methods study of a new asthma specific quality of life questionnaire including limited clinic data. AIMS To collect further quantitative data to validate a new asthma quality of life scale, the Severe Asthma Questionnaire (SAQ). To determine the Minimum Clinically Important Difference (MCID) of the SAQ OUTCOME MEASURES Questionnaires: 1. The Severe Asthma Questionnaire (SAQ) 2. The Mini Asthma Quality of Life Questionnaire (MiniAQLQ) 3. The EQ-5D-5L 4. The Asthma Control Test (ACT)/ Asthma Control Questionnaire (ACQ) 5. Global Rating of Change Questionnaire (GRCQ) Clinical data comprises: 6. Spirometry 7. BMI 8. Asthma severity 9. Health care utilisation: ED attendance in the last 12 months, Hospital admissions in the last 12 months; 10. Number of exacerbations in the last 12 months requiring OCS Prednisolone dose mg/day (if oral steroid dependent). POPULATION All patients aged 16 years or over, who have attended one of three participating UK specialist asthma centres for the validation study and with data also collected from Derriford Hospital's Chest Clinic (DHCC) for use in determining Minimum clinically Important difference. ELIGIBILITY Over 16 years of age Diagnosis of Severe Asthma DURATION 18 months

NCT ID: NCT04022447 Completed - Severe Asthma Clinical Trials

Dupilumab for Severe Asthma in a Real Life Setting

DUPI-France
Start date: August 10, 2018
Phase:
Study type: Observational

Dupilumab is a monoclonal anti-IL-4/13Rα antibody developed for severe asthma (SA). In France, mepolizumab was commercialized in February 2018. Before this date, many SA patients had reached a therapeutic dead end, with uncontrolled disease despite maximal available treatment. Upon the request of lung specialists involved in SA, French health authorities approved an early access program (temporary Use Authorization) allowing early access to dupilumab (before EMA's decision) from September 2017 to January 2018, for SA patients demonstrating unacceptable steroids side effects and/or life-threatening exacerbations, irrespective of their T2 status.The aim of this retrospective study was to describe the characteristics of SA patients included in the early access program and to assess changes in asthma control after a 12 months treatment.

NCT ID: NCT03984253 Recruiting - Severe Asthma Clinical Trials

Swiss Severe Asthma Register

Start date: May 13, 2019
Phase:
Study type: Observational [Patient Registry]

Asthma is one of the most common chronic diseases. Asthma is characterized by chronic airway inflammation and associated with airway hyperresponsiveness and reversible airflow obstruction. The variability of airway obstruction is triggered by different factors that lead to a variety of different asthma phenotypes and subtypes. The various classification options for asthma (e.g. severity, by the predominantly existing inflammation or according to triggers), reflect its heterogeneity. Despite improved therapeutic methods, the prevalence and morbidity of asthma has increased worldwide in the last years. Asthma is a serious and growing global health problem with around 300 million people affected, independent of age or sex. Estimated 250'000 people die prematurely each year due to their asthma. Based on the SAPALDIA-study, the prevalence of Asthma in Switzerland is approximately 2-8%. Asthma is considered as a major factor in healthcare cost with up to CHF 1.2 billion per year. Asthma is not only a financial burden to a system; it affects the individual Quality of life negatively. Often health care professionals and patients underestimate the severity of the disease and overestimate asthma control. Severe asthma should not be equated with uncontrolled asthma. To reach a satisfying asthma control numerous factors need to be taken into consideration. Severe asthma is often associated with a high risk of frequent, severe exacerbations, which can even lead to death. Several severe asthma cohorts and registries already exists and are reported in the literature. The aim of such registries is in general data collection and a better understanding of the disease. So far, most epidemiological studies on severe asthma are cross-sectional with no follow up measures. Only a few studies did repeated measures using the same methods. Approximately 5% of all Asthma Patients suffers from severe asthma. These patients require systematic assessment and specialist care in dedicated respiratory centres. These centres have a key role in improving the outcome for severe asthma patients. At the same time they act as gatekeepers to ensure appropriate access to new, expensive therapies, this includes antibody treatment and interventional methods such as thermoplasty. These treatments require careful monitoring. It is important to ensure that they are given to the right population. Special assessment to monitor the efficacy and to prevent inappropriate prescribing, exposure of patients to unnecessary risks and excessive costs is indicated. For all the mentioned reasons a Swiss Severe Asthma Register and a collaboration with an already existing register is needed to prospectively collect data about severe asthma in Switzerland.