Health TrialsbyHealthPanel

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

ConditionAcute Exacerbation Chronic Obstructive Pulmonary Disease
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAin Shams University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

• 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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Alpha Lipoic Acid 600 MG Oral Tablets

    Drug

    Alpha lipoic acid tablets 600 mg

  • Alpha Lipoic Acid

    Drug

    Alpha lipoic acid tablets 1200 mg

  • Placebo

    Drug

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

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Low dose Alpha lipoic acidActive comparator 1 intervention
Group B: High dose Alpha lipoic acidActive comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Oxidative Stress & Inflammatory Biomarkers

* Malondialdehyde (MDA) * Interleukin-8 (IL-8)

Time frame
Measured at baseline (Day 0) and Day 10

Secondary outcomes

1

Length of hospital stay

Time frame
From the date of randomization until hospital discharge, assessed during the index hospitalization for up to 30 days after randomization.
2

COPD Assessment Test (CAT) score

The COPD Assessment Test (CAT) is a simple, validated 8-item questionnaire used to assess the impact of Chronic Obstructive Pulmonary Disease on a patient's health status and daily life.

Time frame
It will be assessed at baseline of the study and after 10 days
3

Clinical stability

Clinical stability: Defined as the time from initiation of the study intervention until the patient achieves clinical stability, characterized by meeting all of the following criteria and maintaining them for at least 24 consecutive hours: * Resolution of fever: Temperature ≤ 37.5°C * Stable hemodynamics: Heart rate ≤ 100 beats/min and systolic blood pressure ≥ 90 mmHg * Stable respiratory status: Respiratory rate ≤ 24 breaths/min * Improved oxygenation: Oxygen saturation ≥ 90% on room air or stable supplemental oxygen (or baseline if known to be lower) * No need for rescue medications beyond the scheduled regimen

Time frame
From the date of randomization until the date clinical stability is first achieved and maintained for at least 24 consecutive hours, assessed daily during hospitalization for up to 10 days after randomization.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ain Shams University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: