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D011657: Pulmonary Eosinophilia

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (5)


Name (Synonyms) Correlation
drug2339 Mepolizumab 100 MG [Nucala] Wiki 0.71
drug547 Best Standard of Care + CARDIO Wiki 0.71
drug710 CLIA of IgG and IgM against SARS-Cov-2 Wiki 0.71
Name (Synonyms) Correlation
drug726 COVID 19 Diagnostic Test Wiki 0.71
drug546 Best Standard of Care Wiki 0.71

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D001249 Asthma NIH 0.39

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002099 Asthma HPO 0.39

Clinical Trials

Navigate: Correlations   HPO

There are 2 clinical trials


1 Randomized, Open-label, Parallel Study to Investigate Safety and Efficacy of CARDIO Softgels Plus Best Standard-of-care vs. Best Standard-of-care Alone on a Former Smoker and/or Steroid-resistant Asthma Population With COVID-19 Infection

Corona virus disease 2019 (COVID-19) is caused by SARS-CoV-2, a plus-sense single-stranded RNA virus. After an incubation period, which typically lasts for 5-6 days, COVID-19 patients present with a mild illness that lasts for a few days. Common symptoms are reminiscent of the flu, and include fever, dry cough and dyspnea. A large percentage of patients resolve the infection whereas others progress onto adult respiratory distress syndrome (ARDS) which impedes gas exchange between the alveolar space and the bloodstream and creates the need for assisted respiration.The objectives of this randomized, open-label, parallel study is to investigate the safety and efficacy of CARDIO plus best standard-of-care in reducing the need for mechanical respiratory support, alleviating respiratory symptoms and reducing mortality in hospitalized former smoker and steroid-resistant asthma patients with COVID-19 infection.

NCT04465513
Conditions
  1. Asthma; Eosinophilic
  2. COVID
  3. Covid-19
Interventions
  1. Dietary Supplement: Best Standard of Care + CARDIO
  2. Dietary Supplement: Best Standard of Care
MeSH:Asthma Pulmonary Eosinophilia
HPO:Asthma

Primary Outcomes

Description: Oxygen saturation rates (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)

Measure: Oxygenation requirements during hospital stay (oxygen saturation rates)

Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baseline

Description: Requirement for supplemental oxygen (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)

Measure: Oxygenation requirements during hospital stay (supplemental Oxygen)

Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baseline

Description: Requirement for advanced ventilator support (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)

Measure: Oxygenation requirements during hospital stay (ventilator support)

Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baseline

Secondary Outcomes

Description: Assessed by the National Early Warning Score (NEWS) which is a standardized tool that assesses disease severity and monitoring of patients in hospital. An aggregate score of respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness and temperature and the score is increased if supplemental oxygen is required. Each parameter is based on a scale of 0 - 3. 0=good, 3=poor

Measure: Clinical improvement

Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: Assessed by the WHO Ordinal Scale for Clinical Improvement which examines changes in clinical status and/or survival specific to COVID-19. This 8-point scale measures illness severity over time. 0 = no infection and 8 = dead

Measure: Clinical status

Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: Serial chest CT or X-ray findings for the CARDIO softgel + BSC group will be compared with those of the BSC group.

Measure: Serial chest CT or X-ray findings

Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: This is defined as sustained normalization of fever, respiratory rate, oxygen saturation, and alleviation of cough for at least 72 hours

Measure: Time to clinical recovery

Time: Day 28 from baseline or day of discharge

Description: increase in SpO2/FiO2 of 50 mmHg or greater compared to the nadir SpO2/FiO2

Measure: Time to improvement in oxygenation for at least 48 hours

Time: Day 28 from baseline or day of discharge

Description: The number of days from hospital admission to hospital discharge

Measure: Hospitalization period

Time: Day 28 from baseline or day of discharge

Description: The total number of days on ventilator

Measure: Amount of time on Ventilator

Time: Day 28 from baseline or day of discharge

Description: number of days in intensive care unit (ICU)

Measure: Intensive Care stay

Time: Day 28 from baseline or day of discharge

Description: assessed by the COVID-19 QoL questionnaire which asks questions about incident of different parameters related to deteriorating. It is on a scale of 1-5. 1=completely disagree, 5 = completely agree

Measure: Quality of life (QoL)

Time: Day1, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: Death due to COVID-19 and other reasons

Measure: All-cause mortality

Time: Day 28 from baseline or day of discharge

Description: Body temperatures

Measure: Temperature measurements

Time: Day 28 from baseline or day of discharge

Description: measured using a pulse oximetry device, which is a non-invasive method to measure arterial oxygen saturation level.

Measure: Oxygen saturation measurements

Time: Day 28 from baseline or day of discharge

Description: assessed by the COVID-19 QoL questionnaire which asks questions about incident of different parameters related to deteriorating. It is on a scale of 1-5. 1=completely disagree, 5 = completely agree

Measure: COVID-19 QoL measurements

Time: Day 28 from baseline or day of discharge

Other Outcomes

Description: Incidence of pre-emergent and post-emergent adverse events (AEs) and serious adverse events (SAEs)

Measure: Adverse Events

Time: During 15 days of supplementation or until day of discharge and during home follow up

Description: systolic and diastolic

Measure: Blood pressure

Time: From baseline to 28 days thereafter

Description: Heart rate values for the CARDIO softgel + BSC group will be compared with those of the BSC group using

Measure: Heart rate

Time: Everyday From baseline to 28 days thereafter

Description: Frequency of clinically significant laboratory abnormalities.

Measure: Abnormality in laboratory tests

Time: Day 28 from baseline or day of discharge

Description: BMI values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: Body mass Index (BMI)

Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: CBC values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: Complete blood count (CBC)

Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: AST values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: Aspartate transaminase (AST)

Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: ALT values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: Alanine transaminase (ALT)

Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: ALP values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: Alkaline phosphatase (ALP)

Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: Bilirubin values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: Bilirubin

Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: Sodium ion values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: Sodium ion

Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: Potassium ion values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: Potassium ion

Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: Chloride ion values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: Chloride ion

Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: Creatinine values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: Creatinine

Time: Daily From baseline to 28 days thereafter

Description: eGFR values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: eGFR

Time: Daily From baseline to 28 days thereafter

Description: HbA1c values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: HbA1c

Time: Daily From baseline to 28 days thereafter

Description: eGFR values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Measure: Glucose

Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge

Description: CRP value only taken at baseline for every participant

Measure: C-Reactive protein (CRP)

Time: Baseline only
2 Efficacy of Mepolizumab in Patients With Late-onset Severe Eosinophilic Asthma and Fixed Obstruction

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.

NCT04612556
Conditions
  1. Asthma; Eosinophilic
  2. Severe Asthma
  3. Late-Onset Asthma
Interventions
  1. Drug: Mepolizumab 100 MG [Nucala]
MeSH:Asthma Pulmonary Eosinophilia
HPO:Asthma

Primary Outcomes

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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 dif´Čüculties).

Measure: Identification of clinical characteristics of response, change in Athens Insomnia Scale

Time: through study completion, 52 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

Secondary Outcomes

Description: 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 weeks

Description: 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 weeks

Description: 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 weeks

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Data processed on September 26, 2020.

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