NCT07456176Not 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
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 26 Feb 2026
- Start date
- Feb 2026
- Primary completion date
- May 2026
- Lead sponsor
- Ain Shams University
- Diseases
- COPD
- NCT number
- NCT07456176
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 75
- From Feb 2026 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- • Known allergy or intolerance to ALA.
- Cystic fibrosis or bronchiectasis.
- Patients with a history of asthma, pneumonia, interstitial lung disease, bronchiectasis, carcinoma of the bronchus, or other significant respiratory disease
- Active or recent infection with tuberculosis.
- Any other significant comorbid condition that could interfere with study participation or outcomes (e.g., severe liver or kidney disease, uncontrolled cardiovascular disease).
Who the study is looking for
- \- Confirmed diagnosis of COPD, supported by a previous spirometry report showing: Post-bronchodilator FEV₁/FVC \< 0.70, consistent with GOLD criteria for persistent airflow limitation.
- History of frequent exacerbations, defined as two or more COPD exacerbations per year during the two years prior to enrollment.
- An exacerbation of COPD is an acute event characterized by increased dyspnea and/or cough and sputum that worsens within ≤14 days and often results in additional therapy, according to the most recent GOLD guidelines.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Matareya Teaching Hospital Coordinator of this site? Confirm its status | Cairo | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.