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D001249: Asthma

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 (13)


Name (Synonyms) Correlation
drug323 Asthma controller therapies (incl. prednisone/prednisolone) Wiki 0.50
drug1107 Dupilumab (SAR231893/REGN668) Wiki 0.50
drug618 COVID 19 Convalescent Plasma Wiki 0.50
Name (Synonyms) Correlation
drug619 COVID 19 Diagnostic Test Wiki 0.50
drug466 Best Standard of Care + CARDIO Wiki 0.50
drug324 Asthma reliever therapies Wiki 0.50
drug2090 Montelukast Oral Granules Wiki 0.50
drug621 COVID 19 diagnostic test by PCR Wiki 0.50
drug616 COVI-GUARD Wiki 0.50
drug465 Best Standard of Care Wiki 0.50
drug3433 Tezepelumab Wiki 0.35
drug3221 Standard of Care Wiki 0.08
drug2505 Placebo Wiki 0.05

Correlated MeSH Terms (10)


Name (Synonyms) Correlation
D001982 Bronchial Diseases NIH 0.50
D006969 Hypersensitivity, Immediate NIH 0.50
D012130 Respiratory Hypersensitivity NIH 0.50
Name (Synonyms) Correlation
D011657 Pulmonary Eosinophilia NIH 0.50
D006967 Hypersensitivity, NIH 0.22
D007154 Immune System Diseases NIH 0.20
D008173 Lung Diseases, Obstructive NIH 0.14
D008171 Lung Diseases, NIH 0.11
D012140 Respiratory Tract Diseases NIH 0.11
D007249 Inflammation NIH 0.09

Correlated HPO Terms (4)


Name (Synonyms) Correlation
HP:0002099 Asthma HPO 1.00
HP:0012393 Allergy HPO 0.22
HP:0006536 Pulmonary obstruction HPO 0.16
Name (Synonyms) Correlation
HP:0002088 Abnormal lung morphology HPO 0.11

Clinical Trials

Navigate: Correlations   HPO

There are 4 clinical trials


1 Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations

Objective: To determine the extent to which high-dose (30mg) oral montelukast, added to standard treatment in children with moderate and severe acute exacerbations improves outcomes. Central Hypothesis: High-dose oral montelukast, added to standard treatment in children aged 5 to 17 years with moderate and severe acute asthma exacerbations, rapidly improves lung function, clinical severity, hospitalization rate and 72-hour symptom burden. Secondary Hypotheses: 1. There are greater effects of high-dose oral montelukast on lung function and on the secondary outcomes in the presence of respiratory viral detection or leukotriene-mediated inflammation; and 2. There is an interaction between viral detection and urinary leukotriene 4 level with treatment-response. Design: A two-arm, parallel randomized controlled trial of high-dose oral montelukast versus identical placebo, as add-on to standard treatment of systemic corticosteroid (SCS) and inhaled short-acting Beta-2-agonist (SABA), in children aged 5 to 17 years with moderate and severe acute asthma exacerbations. Intervention: High-dose oral montelukast added to standard treatment as one treatment-allocation arm, in comparison with standard treatment as the 2nd treatment-allocation arm. Primary and Important Secondary Endpoints: For the Primary Aim, the primary outcome measure to be compared between arms will be change of %-predicted airway resistance by impulse oscillometry (IOS) at 5Hz (%R5) at 2 hours after treatment initiation. Secondary outcomes will include improvement of %-predicted FEV1 (%FEV1), clinical severity measured using the validated Acute Asthma Intensity Research Score (AAIRS), hospitalization rate, and 72 hour symptom burden using the Pediatric Asthma Caregiver Diary (PACD). For the Secondary Aim, the investigators will determine (1) The effects of high-dose oral montelukast on lung function and on our secondary outcomes in the presence of nasal viruses and of greater leukotriene-mediated inflammation; and (2) The degree of interaction between viral detection and urinary leukotriene E4 (LTE4) level with treatment-response. Laboratory evaluations: The primary outcome (change of %R5) and select secondary outcomes (%FEV1, AAIRS, LTE4) will be measured before and again at 2 hours after treatment initiation. The other secondary outcomes will be measured at the time of hospitalization decision-making by the clinical team (hospitalization rate) or at 72-hours after treatment initiation (PACD).

NCT03277170
Conditions
  1. Asthma; Status
  2. Asthma in Children
  3. Asthma Acute
  4. Asthma Attack
  5. Acute Asthma Exacerbation
Interventions
  1. Drug: Montelukast Oral Granules
MeSH:Asthma
HPO:Asthma

Primary Outcomes

Description: Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometrypost montelukast or control administration

Measure: Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometry

Time: Before and 2-hours after treatment with montelukast or placebo

Secondary Outcomes

Description: Change of percent-predicted forced expiratory volume in 1-second (FEV1)

Measure: Change of percent-predicted forced expiratory volume in 1-second (FEV1)

Time: Before and 2-hours after treatment with montelukast or placebo

Description: Change of the Acute Asthma Intensity Research Score (AAIRS)

Measure: Change of the Acute Asthma Intensity Research Score (AAIRS)

Time: Before and 2-hours after treatment with montelukast or placebo

Description: Leukotriene E4 (LTE4)

Measure: Leukotriene E4 (LTE4)

Time: Before treatment with montelukast or placebo

Description: 72-hours symptom burden measured using the pediatric asthma caregiver diary (PACD)

Measure: 72-hours symptom burden measured using the pediatric asthma caregiver diary (PACD)

Time: Before and at 72-hours after treatment with montelukast or placebo

Description: Hospitalization rate

Measure: Hospitalization rate

Time: 8-hours after treatment with montelukast or placebo
2 One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study

Primary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. Secondary Objectives: - To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: - Systemic exposure. - Anti-drug antibodies (ADAs). - Biomarkers.

NCT03560466
Conditions
  1. Asthma
Interventions
  1. Drug: Dupilumab (SAR231893/REGN668)
  2. Drug: Asthma controller therapies (incl. prednisone/prednisolone)
  3. Drug: Asthma reliever therapies
MeSH:Asthma
HPO:Asthma

Primary Outcomes

Description: The number (n) and percentage (%) of patients experiencing any TEAE

Measure: Treatment-emergent adverse events (TEAEs)

Time: From Day 1 up to Week 64

Secondary Outcomes

Description: Annualized rate of severe asthma exacerbation events, during the treatment period

Measure: Severe asthma exacerbation events

Time: From Day 1 up to Week 52

Description: Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline

Measure: Change in % predicted FEV1

Time: From Day 1 up to Week 64

Description: Change in absolute FEV1 - Clinically significant changes from baseline

Measure: Change in absolute FEV1

Time: From Day 1 up to Week 64

Description: Change in forced vital capacity (FVC)

Measure: Change in FVC

Time: From Day 1 up to Week 64

Description: Change in forced expiratory flow (FEF) 25-75%

Measure: Change in FEF

Time: From Day 1 up to Week 64

Description: Serum dupilumab concentrations - Changes from first dupilumab injection

Measure: Assessment of dupilumab concentration

Time: From Day 1 up to Week 64

Description: Titers of Anti-dupilumab antibodies

Measure: Assessment of immunogenicity

Time: From Day 1 up to Week 64

Description: Blood: Eosinophil count

Measure: Assessment of blood Eosinophil count

Time: From Day 1 up to Week 64

Description: Serum: total IgE

Measure: Assessment of total immunoglobulin E (IgE)

Time: From Day 1 up to Week 64
3 A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults With Inadequately Controlled Asthma on Inhaled Corticosteroids and at Least One Additional Asthma Controller (CASCADE)

A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled asthma.

NCT03688074
Conditions
  1. Asthma
  2. Bronchial Diseases
  3. Respiratory Tract Diseases
  4. Lung Diseases, Obstructive
  5. Lung Diseases
  6. Respiratory Hypersensitivity
  7. Hypersensitivity, Immediate
  8. Hypersensitivity
  9. Immune System Diseases
Interventions
  1. Biological: Tezepelumab
  2. Other: Placebo
MeSH:Asthma Lung Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Bronchial Diseases Respiratory Hypersensitivity Hypersensitivity Immune System Diseases Hypersensitivity, Immediate Inflammation
HPO:Abnormal lung morphology Allergy Asthma Pulmonary obstruction

Primary Outcomes

Description: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.

Measure: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.

Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.

Secondary Outcomes

Description: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies

Measure: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies

Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.

Description: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies

Measure: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies

Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.

Description: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies

Measure: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies

Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
4 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

HPO Nodes


Reports

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.

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