Not Yet RecruitingPhase 3
Effect of Low-Dose Versus High-Dose Alpha-Lipoic Acid on Oxidative Stress, Inflammation, and Clinical Outcomes in Acute Exacerbations of Chronic Obstructive Pulmonary Disease
NCT07456176
Chronic Obstructive Pulmonary Disease (COPD) is a progressive inflammatory lung disease characterized by persistent airflow limitation and enhanced oxidative stress. Acute exacerbations of COPD (AECOPD) significantly increase morbidity, accelerate lung function decline, and worsen clinical outcomes. Oxidative stress plays a central role in AECOPD pathophysiology by amplifying inflammation through mediators such as IL-8 and TNF-α, leading to airway injury and impaired gas exchange.
Alpha Lipoic Acid (ALA) is a potent antioxidant and anti-inflammatory agent that scavenges reactive oxygen species, regenerates endogenous antioxidants, and modulates redox-sensitive inflammatory pathways. Although preclinical evidence supports its protective role in respiratory diseases, no randomized clinical trial has evaluated ALA in AECOPD or compared different dosing strategies.
Aim
This study aims to evaluate and compare the effects of low-dose (600 mg/day) versus high-dose (1200 mg/day) ALA on oxidative stress markers, inflammatory biomarkers, clinical recovery, pulmonary oxygenation, gas exchange, and safety in patients with AECOPD.
Methods
This is a prospective, double-blind, randomized controlled trial conducted in the ICU at El Matareya Teaching Hospital. Adult patients (40-70 years) with confirmed COPD and frequent exacerbations were randomized (1:1:1) into three groups:
Group A: Standard therapy + placebo
Group B: Standard therapy + 600 mg/day oral ALA
Group C: Standard therapy + 1200 mg/day oral ALA
All patients received guideline-based AECOPD management according to GOLD recommendations, including bronchodilators, systemic corticosteroids, antibiotics (when indicated), oxygen therapy, and ventilatory support as needed.
Assessments
Baseline and Day 10 evaluations included:
Primary Outcomes:
Oxidative stress marker: Malondialdehyde (MDA)
Inflammatory markers: Interleukin-8 (IL-8) and C-reactive protein (CRP)
Secondary Outcomes:
Time to clinical stability
ICU and hospital length of stay
Need for non-invasive or invasive ventilation
Early relapse (14 days) and 30-day readmission
Gas Exchange: ABGs (pH, PaO₂, PaCO₂, P/F ratio)
Patient-Reported Outcomes: COPD Assessment Test (CAT) and mMRC dyspnea scale
Safety: Monitoring for adverse effects including gastrointestinal symptoms, hypoglycemia, dizziness, and hypersensitivity reactions.
Acute Exacerbation Chronic Obstructive Pulmonary Disease
Ain Shams University75 participantsStarted Feb 2026 