Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
The Effect of Selenium Supplementation on Anti-Oxidant Levels in COPD Patients: A 12-Week, Randomized, Placebo-Controlled Trial
Does an oral selenium supplement increase blood levels of antioxidants in patients with
established, smoking-related lung disease?
Members of our study group recently discovered that elevated levels of the anti-oxidant GPx-1
may be protective against heart disease. We are studying whether selenium supplementation
will improve GPx-1 levels.
Patients with chronic obstructive pulmonary disease (COPD) are at high risk for
atherosclerotic heart disease, in part because of their nearly universal exposure to heavy
smoking, and in part to other incompletely understood mechanisms which may include
inflammation and anti-oxidant status.
Smoking markedly affects both circulating inflammatory markers concentrations, and the
anti-oxidant glutathione peroxidase-1 (GPx-1). We hypothesize that smoking-related
inflammation and anti-oxidant consumption lead to both cardiovascular (CV) and respiratory
disease. In a recent study, we (Blankenberg et al) found that higher levels of GPx-1 were
associated with lower rates af future CV events and death. GPx-1 levels were lower among
smokers, and the combination of current smoking and GPx-1 levels below the median was
strongly (HR=5.6) and significantly associated with future CV events and death.
There is a biological and epidemiological rationale to study selenium supplementation for CV
protection. GPx-1 is a selenium-dependent enzyme, and data support the hypothesis that
selenium supplementation increases GPx activity in various diseases. Furthermore,
epidemiologic studies have discovered an inverse association between selenium content in soil
and CV incidence and mortality. We hypothesize that selenium supplementation will elevate
intra-erythrocytic GPx-1 levels in COPD patients and, ultimately, retard CV progression.
In this study, we will test the first component of this assertion. In a randomized,
placebo-controlled trial, we will determine whether 12 weeks of selenium supplementation
increases GPx-1 levels among 120 COPD patients. If successful, this study may lead to future
large clinical trials to assess whether selenium, an inexpensive and safe mineral, improves
clinical outcomes in cardiovascular and respiratory disease.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|