Covid 19 Research using Clinical Trials (Home Page)
Report for D004646: Emphysema NIH
(Synonyms: Emphysema)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (4)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug650 | Chest physiotherapy using a non-invasive oscillating device Wiki | 0.71 |
| drug86 | ARALAST NP Wiki | 0.71 |
| drug2133 | Placebo Comparator Wiki | 0.71 |
| drug367 | Bacille Calmette-Guérin (BCG) Wiki | 0.71 |
Correlated MeSH Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001469 | Barotrauma NIH | 0.71 |
| D019896 | Alpha 1-Antitrypsin Deficiency NIH | 0.71 |
| D001987 | Bronchiectasis NIH | 0.41 |
| D008171 | Lung Diseases, NIH | 0.33 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.25 |
| D008173 | Lung Diseases, Obstructive NIH | 0.24 |
| D017563 | Lung Diseases, Interstitial NIH | 0.20 |
| D011024 | Pneumonia, Viral NIH | 0.09 |
| D011014 | Pneumonia NIH | 0.04 |
Correlated HPO Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002110 | Bronchiectasis HPO | 0.41 |
| HP:0002088 | Abnormal lung morphology HPO | 0.33 |
| HP:0006510 | Chronic pulmonary obstruction HPO | 0.25 |
| HP:0006536 | Pulmonary obstruction HPO | 0.24 |
| HP:0006515 | Interstitial pneumonitis HPO | 0.20 |
| HP:0002090 | Pneumonia HPO | 0.04 |
There are 2 clinical trials
Clinical Trials
1 SequelaeCov: a Prospective Study on Lung Damage Caused by SARS-CoV-2 Pneumonia
Pneumonia is a recurrent element of COVID-19 infection, it is often associated with development of respiratory failure and patients frequently need various degrees of oxygen therapy up to non invasive ventilation (NIV-CPAP) and invasive mechanical ventilation (IMV). Main purpose of this study is to evaluate with non invasive clinical instruments (pletysmography, Diffusion lung capacity for carbon monoxide -DLCO-, six minute walking test and dyspnea scores) and radiological tools (chest X-ray and chest CT scan) the development of medium-to-long term pulmonary sequelae caused by SARS-CoV-2 pneumonia.
NCT04435327 COVID Pneumonia, Viral Barotrauma Interstitial Lung Disease Bronchiectasis Adult Emphysema MeSH:Pneumonia, Viral Pneumonia Lung Diseases Bronchiectasis Lung Diseases, Interstitial Emphysema Barotrauma
HPO:Abnormal lung morphology Bronchiectasis Interstitial pneumonitis Interstitial pulmonary abnormality Pneumonia
Primary Outcomes
Description: Reduction below 80% of predicted values of DLCO
Measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique) Time: T1 at 6 months from discharge
Description: Reduction below 80% of predicted values of DLCO
Measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique) Time: T2 at 12 months from discharge
Secondary Outcomes
Description: reduction in maximum distance walked
Measure: Alterations in 6 minute walking test (6MWT) Time: T1 at 6 months from discharge
Description: reduction in maximum distance walked
Measure: Alterations in 6 minute walking test (6MWT) Time: T2 at 12 months from discharge
Description: reduction in oxygen saturation nadir
Measure: Alterations in 6 minute walking test (6MWT) Time: T1 at 6 months from discharge
Description: reduction in oxygen saturation nadir
Measure: Alterations in 6 minute walking test (6MWT) Time: T2 at 12 months from discharge
Description: reduction of Forced Vital Capacity (FVC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: reduction of Forced Vital Capacity (FVC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: reduction of Forced Vital Capacity (FVC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: reduction of Forced Vital Capacity (FVC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: reduction of Vital Capacity (VC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: reduction of Vital Capacity (VC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: reduction of Vital Capacity (VC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: reduction of Vital Capacity (VC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: reduction of Forced Expiratory Volume in the 1st second (FEV1, %)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: reduction of Total Lung Capacity (TLC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: reduction of Total Lung Capacity (TLC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: reduction of Total Lung Capacity (TLC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: reduction of Total Lung Capacity (TLC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: alterations of Residual Volume (RV,%)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: alterations of Residual Volume (RV, L)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: alterations of Residual Volume (RV, L)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: alterations of Residual Volume (RV, %)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: increase of Specific Airway Resistance (sRAW) (absolute value)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: increase of Specific Airway Resistance (sRAW) (%)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: increase of Specific Airway Resistance (sRAW) (absolute value)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: increase of Specific Airway Resistance (sRAW) (%)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: alterations of Motley Index (VR/CPT)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: alterations of Motley Index (VR/CPT)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: alterations of Tiffeneau Index (IT)
Measure: Alterations of pletismography Time: T1 at 6 months from discharge
Description: alterations of Tiffeneau Index (IT)
Measure: Alterations of pletismography Time: T2 at 12 months from discharge
Description: reduction of PaO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T1 at 6 months from discharge
Description: reduction of PaO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T2 at 12 months from discharge
Description: alteration of PaCO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T1 at 6 months from discharge
Description: alteration of PaCO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T2 at 12 months from discharge
Description: Modified Medical Research Council - mMRC > 0 (minimum 0, maximum 4; higher score means worse outcome)
Measure: Abnormal Dyspnea Score Time: T1 at 6 months from discharge
Description: Modified Medical Research Council - mMRC > 0(minimum 0, maximum 4; higher score means worse outcome)
Measure: Abnormal Dyspnea Score Time: T2 at 12 months from discharge
Description: Presence and extension of abnormal pulmonary lung sounds at auscultation
Measure: Presence and extension of abnormal pulmonary lung sounds at auscultation Time: T1 at 6 months from discharge
Description: Presence and extension of abnormal pulmonary lung sounds at auscultation
Measure: Presence and extension of abnormal pulmonary lung sounds at auscultation Time: T2 at 12 months from discharge
Description: Presence and extension of radiological alterations at chest X-ray
Measure: Presence and extension of radiological alterations at chest X-ray Time: T1 at 6 months from discharge
Description: Presence and extension of radiological alterations at chest CT scan
Measure: Presence and extension of radiological alterations at chest CT scan Time: T2 at 12 months from discharge
2 A Prospective, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of ARALAST NP 60 mg/kg and 120 mg/kg for Alpha-1 Proteinase Inhibitor (A1PI) Augmentation Therapy in Subjects With A1PI Deficiency and Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E)
Primary Outcomes
Description: Reduction below 80% of predicted values of DLCO
Measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique) Time: T1 at 6 months from dischargeDescription: Reduction below 80% of predicted values of DLCO
Measure: Reduction of Diffusion of Lung CO (DLCO, single breath technique) Time: T2 at 12 months from dischargeSecondary Outcomes
Description: reduction in maximum distance walked
Measure: Alterations in 6 minute walking test (6MWT) Time: T1 at 6 months from dischargeDescription: reduction in maximum distance walked
Measure: Alterations in 6 minute walking test (6MWT) Time: T2 at 12 months from dischargeDescription: reduction in oxygen saturation nadir
Measure: Alterations in 6 minute walking test (6MWT) Time: T1 at 6 months from dischargeDescription: reduction in oxygen saturation nadir
Measure: Alterations in 6 minute walking test (6MWT) Time: T2 at 12 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Vital Capacity (FVC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Vital Capacity (VC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Vital Capacity (VC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Vital Capacity (VC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Vital Capacity (VC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Forced Expiratory Volume in the 1st second (FEV1, L%)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Total Lung Capacity (TLC, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Total Lung Capacity (TLC, %)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: reduction of Total Lung Capacity (TLC, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of Total Lung Capacity (TLC, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Residual Volume (RV,%)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Residual Volume (RV, L)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Residual Volume (RV, L)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Residual Volume (RV, %)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (absolute value)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (%)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (absolute value)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: increase of Specific Airway Resistance (sRAW) (%)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Motley Index (VR/CPT)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Motley Index (VR/CPT)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: alterations of Tiffeneau Index (IT)
Measure: Alterations of pletismography Time: T1 at 6 months from dischargeDescription: alterations of Tiffeneau Index (IT)
Measure: Alterations of pletismography Time: T2 at 12 months from dischargeDescription: reduction of PaO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T1 at 6 months from dischargeDescription: reduction of PaO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T2 at 12 months from dischargeDescription: alteration of PaCO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T1 at 6 months from dischargeDescription: alteration of PaCO2 mmHg
Measure: Alterations of Arterial Blood Gas Analysis Time: T2 at 12 months from dischargeDescription: Modified Medical Research Council - mMRC > 0 (minimum 0, maximum 4; higher score means worse outcome)
Measure: Abnormal Dyspnea Score Time: T1 at 6 months from dischargeDescription: Modified Medical Research Council - mMRC > 0(minimum 0, maximum 4; higher score means worse outcome)
Measure: Abnormal Dyspnea Score Time: T2 at 12 months from dischargeDescription: Presence and extension of abnormal pulmonary lung sounds at auscultation
Measure: Presence and extension of abnormal pulmonary lung sounds at auscultation Time: T1 at 6 months from dischargeDescription: Presence and extension of abnormal pulmonary lung sounds at auscultation
Measure: Presence and extension of abnormal pulmonary lung sounds at auscultation Time: T2 at 12 months from dischargeDescription: Presence and extension of radiological alterations at chest X-ray
Measure: Presence and extension of radiological alterations at chest X-ray Time: T1 at 6 months from dischargeDescription: Presence and extension of radiological alterations at chest CT scan
Measure: Presence and extension of radiological alterations at chest CT scan Time: T2 at 12 months from dischargeThe purpose of this study is to evaluate the efficacy of ARALAST NP A1PI augmentation therapy 120 milligrams per kilogram (mg/kg) body weight (BW)/week compared with an external placebo comparator on the loss of emphysematous lung tissue measured by lung density change in participants with A1PI deficiency and COPD-E.
NCT04440488 Chronic Obstructive Pulmonary Disease Alpha1-antitrypsin Deficiency Biological: ARALAST NP MeSH:Alpha 1-Antitrypsin Deficiency Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Emphysema
HPO:Abnormal lung morphology Chronic pulmonary obstruction Pulmonary obstruction
Primary Outcomes
Description: Annual rate of the physiologically adjusted lung density change will be measured as the 15th percentile of the lung density measurements (PD15) as assessed by Computed Tomography (CT) densitometry at total lung capacity (TLC). CT lung density at the 15th percentile (PD15) is the threshold below which 15 percentage (%) of the voxels have lower densities and is used as the parameter for estimating the rate of lung density decline. Annual rate of the physiologically adjusted lung density change will be tested in a fixed comparision sequence 1. ARALAST NP 120 mg/kg BW/week group versus (vs) external placebo group, 2. ARALAST NP120 mg/kg BW/week vs 60 mg/kg BW/week, 3. ARALAST NP 60 mg/kg BW/week group vs external placebo group.
Measure: Annual Rate of the Physiologically Adjusted Lung Density Change Time: Baseline, up to Week 104
Secondary Outcomes
Description: COPD exacerbations are defined as an acute worsening of respiratory symptoms that results in additional therapy and will be assessed according to the classification in GOLD criteria (2020) as follows: Moderate (treated with short acting bronchodilators [SABDs] plus antibiotics and/or oral corticosteroids) and Severe (required hospitalizations or a visit to the emergency room).
Measure: Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Time: Baseline, up to Week 104
Description: Annual rate of change in post-bronchodilator FEV1 will be assessed.
Measure: Annual Rate of Change in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Time: Baseline, up to Week 104
Description: An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this IP or medicinal product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. TEAE's will include related, serious adverse events (SAEs), suspected adverse reactions plus adverse reactions of interest, temporally-associated adverse events (AEs) with onset during infusion or within 24 hours following the end of IP infusion, and AEs resulting in changes to infusion dose.
Measure: Number of Participants with Treatment-Emergent Adverse Events (TEAE's) Time: From Start of the study drug administration up to End of the study (up to Week 105)
Description: Number of participants who develop anti- A1PI antibodies following treatment with ARALAST NP will be assessed.
Measure: Number of Participants Who Develop Anti-A1PI Antibodies Following Treatment With ARALAST NP Time: From Start of the study drug administration up to End of the study (up to Week 105)
Description: Plasma trough level of antigenic and functional A1PI for ARALAST NP at each dose level (ARALAST NP 60 mg/kg BW/week, ARALAST NP 120 mg/kg BW/week) will be assessed.
Measure: Plasma Trough Level of Antigenic and Functional A1PI for ARALAST NP at each dose Level Time: Pre-dose, Weeks 4, 13, 28, 52, 78, 91, 104, 105
HPO Nodes
Primary Outcomes
Description: Annual rate of the physiologically adjusted lung density change will be measured as the 15th percentile of the lung density measurements (PD15) as assessed by Computed Tomography (CT) densitometry at total lung capacity (TLC). CT lung density at the 15th percentile (PD15) is the threshold below which 15 percentage (%) of the voxels have lower densities and is used as the parameter for estimating the rate of lung density decline. Annual rate of the physiologically adjusted lung density change will be tested in a fixed comparision sequence 1. ARALAST NP 120 mg/kg BW/week group versus (vs) external placebo group, 2. ARALAST NP120 mg/kg BW/week vs 60 mg/kg BW/week, 3. ARALAST NP 60 mg/kg BW/week group vs external placebo group.
Measure: Annual Rate of the Physiologically Adjusted Lung Density Change Time: Baseline, up to Week 104Secondary Outcomes
Description: COPD exacerbations are defined as an acute worsening of respiratory symptoms that results in additional therapy and will be assessed according to the classification in GOLD criteria (2020) as follows: Moderate (treated with short acting bronchodilators [SABDs] plus antibiotics and/or oral corticosteroids) and Severe (required hospitalizations or a visit to the emergency room).
Measure: Number of Moderate or Severe Exacerbations of Chronic Obstructive Pulmonary Disease (COPD) Time: Baseline, up to Week 104Description: Annual rate of change in post-bronchodilator FEV1 will be assessed.
Measure: Annual Rate of Change in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) Time: Baseline, up to Week 104Description: An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this IP or medicinal product. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an IP or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the IP or medicinal product. TEAE's will include related, serious adverse events (SAEs), suspected adverse reactions plus adverse reactions of interest, temporally-associated adverse events (AEs) with onset during infusion or within 24 hours following the end of IP infusion, and AEs resulting in changes to infusion dose.
Measure: Number of Participants with Treatment-Emergent Adverse Events (TEAE's) Time: From Start of the study drug administration up to End of the study (up to Week 105)Description: Number of participants who develop anti- A1PI antibodies following treatment with ARALAST NP will be assessed.
Measure: Number of Participants Who Develop Anti-A1PI Antibodies Following Treatment With ARALAST NP Time: From Start of the study drug administration up to End of the study (up to Week 105)Description: Plasma trough level of antigenic and functional A1PI for ARALAST NP at each dose level (ARALAST NP 60 mg/kg BW/week, ARALAST NP 120 mg/kg BW/week) will be assessed.
Measure: Plasma Trough Level of Antigenic and Functional A1PI for ARALAST NP at each dose Level Time: Pre-dose, Weeks 4, 13, 28, 52, 78, 91, 104, 105