TABLE 1.
Key ongoing or recently completed interventional trials in COPD, type-2 diabetes mellitus (T2D) and cardiovascular disease (CVD) related to the mechanisms of ageing, inflammation and cellular phenotype
| Study name | Study identifier | Study overview | Disease area | Phase |
| Ageing | ||||
| HIV-related Accelerated Aging of the Airway Epithelium | NCT01974219 | Observational study investigating the role HIV may play in the accelerated ageing of the small airway endothelium and development of COPD | COPD | N/A |
| Pulmonary Rehabilitation Innovation and Microbiota in Exacerbations of COPD (PRIME) | NCT03701945 | An interventional study to investigate how the microbiota of the lungs contributes to pulmonary ageing and AECOPD, and the impact pulmonary rehabilitation has on AECOPD | COPD | N/A |
| In Utero Smoking and Premature Cellular Senescence | NCT01865435 | A trial to investigate telomere length as a surrogate for cellular senescence in peripheral lymphocytes obtained from the cord blood of newborns from mothers with absence of smoking or smoking >5 cigarettes per day | COPD | N/A |
| Nutritional and Functional Changes in Heart Failure and COPD | NCT01787682 | An interventional trial to investigate gut absorption in patients with CVD or COPD and if this can be improved with a high protein supplement to reduce muscle loss in these patients | CVD, COPD | N/A |
| Cardio-vascular Protective Effects of Wolfberry in Middle-aged and Older Adults | NCT03535844 | A single-blind 16-week study investigating the protective effects of Wolfberry in positively changing endothelial function and lipidomic profiles | CVD | N/A |
| Regulation of Endothelial Progenitor Cells by Short-Term Exercise (EPC-Ex) | NCT01169831 | An open interventional study investigating the effects of exercise on endothelial progenitor cell numbers in sedentary older adults and older endurance athletes | CVD | N/A |
| Prevention of Cardiovascular Stiffening With Aging and Hypertensive Heart Disease (LVH) | NCT03476785 | An open interventional trial to assess how exercise intervention prevents the age-related stiffening of the left ventricule and vasculature | CVD | N/A |
| n-3 PUFA for Vascular Cognitive Aging | NCT01953705 | A 3-year interventional study to investigate if omega 3 PUFA can support small blood vessels in the brain and promote brain health in adults >75 years of age with a high risk of cognitive decline | CVD | 2 |
| Impact of Ageing on Adipose, Muscle and Systemic Inflammation | NCT02777138 | Observational study of macrophage and T-cells in adipose tissue and inflammatory markers (mRNA and protein secretions) between a group of younger and older males with similar lifestyles | CVD, T2D | N/A |
| Cell Signaling and Resistance to Oxidative Stress: Effects of Aging and Exercise | NCT03419988 | An open interventional study investigating the effects of exercise on the expression of an antioxidant regulation protein nuclear erythroid-2-p45-related factor-2 (Nrf2) in peripheral blood mononuclear cells in healthy younger (18–28 years) and older (>60 years) adults | CVD, T2D | N/A |
| Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health (REALPA) | NCT03771417 | An interventional study to assess the impact of resistance exercise with low-intensity physical activity breaks on skeletal muscle and cardiometabolic health in adults aged 65–80 years | CVD, T2D | N/A |
| Dietary Reduction of AGEs to Prevent Cognitive Decline in Elderly Diabetics | NCT02739971 | An intervention pilot study to investigate if it is feasible to reduce dietary AGEs and therefore reduce cognitive decline | T2D | N/A |
| Inflammation | ||||
| Efficacy of Periodontal Treatment on Systemic Inflammation and for Prevention of Exacerbations in Patients With COPD (Expertention) | NCT03279718 | An interventional pilot study to investigate if periodontal treatment can reduce systemic inflammatory markers (including CRP and IL-1b and IL-6) | COPD | N/A |
| INvestigating COPD Outcomes, Genomics and Neutrophilic Inflammation With Tiotropium and Olodaterol (INCOGNITO) | NCT03152149 | An open-label interventional trial comparing treatment of patients with COPD with tiotropium and olodaterol reduces bacterial load and neutrophilic inflammation versus inhaled fluticasone furoate and vilanterol | COPD | 4 |
| Pivotal Study to Assess the Efficacy, Safety and Tolerability of Dupilumab in Patients With Moderate-to-severe COPD With Type 2 Inflammation (BOREAS) | NCT03930732 | An interventional study to assess the efficacy of dupilumab (an IL-4 receptor alpha antibody) in reducing the annual exacerbation rate in patients with moderate-to-severe COPD | COPD | 3 |
| Biological Effects of Quercetin in COPD | NCT03989271 | A study to determine if a dietary supplement, quercetin, can enhance anti-inflammatory effects in patients with COPD and reduce markers of oxidative stress and inflammation | COPD | 1/2 |
| Anti-ST2 (MSTT1041A) in COPD (COPD-ST2OP) | NCT03615040 | An interventional study to assess the use of an IL-33 inhibitor on the frequency of AECOPD events in patients with COPD over 48 weeks | COPD | 2 |
| A 12-week Study Treating Participants Who Have alpha1-antitrypsin-related COPD With Alvelestat (MPH966) or Placebo (ASTRAEUS) | NCT03636347 | An interventional study investigating the effects of a neutrophil elastase inhibitor in patients with α1-antitrypsin deficient Pizz or null phenotype with COPD. Outcomes include sputum and blood inflammatory biomarkers, including neutrophil elastase activity. | COPD | 2 |
| Effect of IL-1β Inhibition on Inflammation and Cardiovascular Risk | NCT02272946 | An interventional study to investigate the effects of IL-1β inhibitor canakinumab in reducing vascular inflammation in HIV-infected individuals | CVD | 2 |
| ASSessing the Effect of Anti-IL-6 Treatment in Myocardial Infarction: The ASSAIL-MI Trial (ASSAIL-MI) | NCT03004703 | An interventional study to assess the impact of a single administration of an anti-IL-6 antibody, tocilizumab, on myocardial damage following myocardial infarction | CVD | 2 |
| Effects of SGLT-2 Inhibition on Myocardial Fibrosis and Inflammation as Assessed by Cardiac MRI in Patients With DM2 | NCT03782259 | An interventional study to investigate how inhibition of a glucose transporter, SGLT-2, with dapagliflozin impacts cardiovascular health and inflammation in patients with T2D | CVD, T2D | 4 |
| Cellular processes | ||||
| Early iNO for Oxidative Stress, Vascular Tone and Inflammation in Babies With Hypoxic Respiratory Failure | NCT01891500 | An interventional study to investigate an already approved intervention, inhaled nitric oxide, in newborns with hypoxic respiratory failure to reduce biomarkers of oxidative injury | CVD | 4 |
| Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients | NCT03506633 | An interventional study to examine the impact of a mitochondrial antioxidant (MitoQ) on vascular endothelial function in patients with peripheral vascular disease | CVD | N/A |
| Effects of Saxagliptin on Adipose Tissue Inflammation in Humans | NCT02285985 | An interventional study to investigate the effects of saxagliptin on adipose tissue inflammation in obese participants | T2D | 4 |
AECOPD: acute exacerbations of COPD; PUFA: polyunsaturated fatty acid; AGEs: advanced glycation end-products; CRP: C-reactive protein; IL: interleukin; MRI: magnetic resonance imaging; DM2: type-2 diabetes; N/A: not available; iNO: inhaled nitric oxide.