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There is one clinical trial.
Interleukin (IL)-5 is the main cytokine responsible for the activation of eosinophils, hence therapeutic strategies have been investigated and developed for clinical use. Biologics targeting IL-5 and its receptor (first mepolizumab and subsequently, reslizumab and benralizumab), have been recently approved and used as add-on therapy for severe eosinophilic asthma resulting in a reduction in the circulating eosinophil count, improvement in lung function and exacerbation reduction in patients with severe asthma. Response to biologic therapies in severe asthma is variable, with patients being either non-responders, responders or super-responders. There is currently no explanation for this broad variation in response. It is important to examine whether these patients have distinct characteristics that could help the treating physician in making the correct diagnosis in clinical practice. Aim of this clinical study is to evaluate the efficacy of mepolizumab, a humanized IL-5 antagonist monoclonal antibody in patients with late-onset severe eosinophilic asthma with fixed obstruction and to identify the characteristics of non-responders and super-responders under mepolizumab treatment. This study is considered as non-interventional and every procedure included is happening in a clinical routine for the diagnosis and phenotyping of the asthmatic patients. Hypothesis includes the efficacy of mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction and relation to clinical and inflammatory biomarkers. Patients will be collected from the outpatient clinics of bronchial asthma from each site included (8 in number) which cover the whole population of Greece. Overall, this is a prospective multicenter study including eight Pulmonary Clinics. Five Pulmonary University Clinics, two of National Health System and one Army General Hospital in Thessaloniki. The study will include a screening period of up to 2 weeks to assess eligibility and obtain written informed consent, a mepolizumab treatment period of 52 weeks, once every 4 weeks, including follow up visits every 3 months during treatment. The study population will consist of 45 patients with late-onset severe eosinophilic asthma and fixed obstruction receiving mepolizumab, aged 20 and above.
Description: Mesurement of the change in exacerbation rate in each late-onset severe eosinophilic asthmatic patient with fixed obstruction under mepolizumab treatment for 52 weeks of treatment.
Measure: Change in exacerbation rate Time: through study completion, 52 weeksDescription: The identification of clinical characteristics of non-responders and super-responders. FEV1 change from baseline, before treatment initiation, compared to measurements every 3 months until 1 year of treatment. FEV1 is the maximal amount of air you can forcefully exhale in one second measured by spirometry.
Measure: Identification of clinical characteristics of response, change in Forced Expiratory Volume (FEV1) Time: through study completion, 52 weeksDescription: The identification of clinical characteristics of non-responders and super-responders. Change from baseline, before treatment initiation, compared to measurements every 3 months until 1 year of treatment.
Measure: Identification of clinical characteristics of response, change in blood eosinophil levels. Time: through study completion, 52 weeksDescription: The identification of clinical characteristics of non-responders and super-responders. Change from baseline, before treatment initiation, compared to measurements every 3 months until 1 year of treatment.
Measure: Identification of clinical characteristics of response, change in FENO levels. Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: the Asthma Control Questionnaire (ACQ-5) to assess current asthma control. Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Measure: Identification of clinical characteristics of response, change in Asthma Control Questionnaire Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: Asthma Control Test (ACT) to assess current asthma control. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
Measure: Identification of clinical characteristics of response, change in Asthma Control Test Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: the Asthma Quality of Life Questionnaire (AQLQ+12) to assess quality of life and psychological morbidity. Scores range 1-7, with higher scores indicating better quality of life.
Measure: Identification of clinical characteristics of response, change in Asthma Quality of Life Questionnaire Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: Athens Insomnia Scale (AIS) to assess sleeping quality. Total score range form 0 to 24 with higher scores indicating worst sleeping quality. AIS includes 8 questions with scores range from 0 (meaning that the item in question has not been a problem) to 3 (indicating more acute sleep difficulties).
Measure: Identification of clinical characteristics of response, change in Athens Insomnia Scale Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: Epworth Sleepiness Scale (ESS) to assess sleeping quality. The total score can range from 0 to 24. Higher scores indicate increased sleepiness.
Measure: Identification of clinical characteristics of response, change in Epworth Sleepiness Scale Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: St. George's Respiratory Questionnaire (SGRQ) to assess sleeping quality. Scores range from 0 to 100, with higher scores indicating more limitations.
Measure: Identification of clinical characteristics of response, change in St. George's Respiratory Questionnaire Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: WHO (Five) Well-Being Index (WHO-5) to assess sleeping quality. The total raw score ranges from 0 to 25, is multiplied by 4 to give the final score, with 0 representing the worst imaginable well-being and 100 representing the best imaginable well-being.
Measure: Identification of clinical characteristics of response, change in WHO (Five) Well-Being Index Time: through study completion, 52 weeksDescription: Identification of any improvement in patients' quality of life during mepolizumab treatment in late-onset severe eosinophilic asthmatic patients with fixed obstruction, from baseline, before treatment initiation, compared to every 3 months until 1 year of treatment. Questionnaire included: Fatigue Severity Scale (FSS) to assess sleeping quality. FSS includes a 9-item questionnaire with questions scored on a 7 point scale with 1 meaning strongly disagree and 7 meaning strongly agree. Scores range from 9 to 63. Higher the score indicates greater fatigue severity.
Measure: Identification of clinical characteristics of response, change in Fatigue Severity Scale Time: through study completion, 52 weeksDescription: The identification of clinical characteristics of non-responders and super-responders. Any improvement in smooth muscle cell mass will be measured as change from baseline compared to measurement after 1 year of treatment. Increased smooth muscle cell mass indicates airway remodeling and loss of pulmonary function. Smooth muscle cell mass will be determined through the epithelial integrity, reticular basement membrane length and vascularity area.
Measure: Change in smooth muscle cell mass Time: through study completion, 52 weeksDescription: To identify any possible biomarkers of response of non-responders versus super-responders in different biological fluids as peripheral blood, bronchial washing, sputum, sputum supernatant. The identification of clinical characteristics of non-responders and super-responders. Change from baseline compared to measurements after 6 months and after 1 year of mepolizumab treatment.
Measure: Change of T-lympocytes percentages Time: through study completion, 52 weeksDescription: To identify any possible biomarkers of response of non-responders versus super-responders in different biological fluids as peripheral blood, bronchial washing, sputum, sputum supernatant. The identification of clinical characteristics of non-responders and super-responders. Change from baseline compared to measurements after 6 months and after 1 year of mepolizumab treatment.
Measure: Change of cytokine and protein levels Time: through study completion, 52 weeksAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports