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 · tracked via the Priya Life Science Egypt tracker

Sponsor

Ain Shams University

Phase

Phase 3

Started

2026-02-28

Last updated

2026-03-30

Condition(s) studied

Acute Exacerbation Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

Alpha Lipoic Acid 600 MG Oral Tablets →Alpha Lipoic Acid →Placebo

Alpha Lipoic Acid 600 MG Oral Tablets: Alpha lipoic acid tablets 600 mg

Alpha Lipoic Acid: Alpha lipoic acid tablets 1200 mg

Placebo: Patients in this group will receive standard therapy for AECOPD along with matching placebo capsules administered orally for 10 days.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: \- 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. Exclusion Criteria: * • 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).

Primary outcome measure(s)

Oxidative Stress & Inflammatory Biomarkers — Measured at baseline (Day 0) and Day 10
* Malondialdehyde (MDA) * Interleukin-8 (IL-8)

Trial sites (1)

Facility	City	Region	Status
Matareya Teaching Hospital	Cairo	Egypt

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07456176 on ClinicalTrials.gov ↗ ← All trials in Egypt