Adjunctive Role of Statin Therapy on Airway Inflammation and Clinical Consequences of Chronic Obstructive Pulmonary Disease

This study aimed to evaluate the impact of statin therapy on the clinical consequences, as well as airway inflammation and radiological features, in severe chronic obstructive pulmonary cases.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; Airway Disease; Statin
• Intervention / Treatment: Drug: Statin; Other: placepo intervention

Detailed Description

Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow obstruction due to chronic respiratory symptoms and abnormalities in the airways and alveoli. Despite new treatment developments, mortality rates remain high in both developed and developing countries. Chronic airway inflammation significantly contributes to Chronic obstructive pulmonary disease, with statins like atorvastatin showing potential benefits beyond lipid lowering. Observational studies suggest statins may reduce exacerbations and mortality; however, systematic reviews indicate inconsistent clinical benefits. A 2023 meta-analysis noted possible improvements in lung function and inflammation but called for more rigorous trials. A recent 2024 study indicated a minimal impact of statins on exacerbation risk in patients with cardiovascular comorbidities, highlighting ongoing controversy. In light of these findings, a focused randomized trial is proposed for GOLD Group E chronic obstructive pulmonary disease patients at higher exacerbation risk, testing atorvastatin's effectiveness on various outcomes.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Al Mansurah, Egypt
    • utpatient clinic and Inpatient quarters of the Thoracic Medicine Department of Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed Chronic Obstructive Pulmonary Disease per the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria 2025 (post-bronchodilator forced expiratory volume₁/forced vital capacity < 0.70), meets the definition of grade E Chronic Obstructive Pulmonary Disease by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria 2025 criteria.
• Age ≥ 40 years

Exclusion Criteria:

• Chronic lung diseases other than COPD as bronchial asthma, interstitial lung disease
• Acute or chronic Inhalational lung injury.
• Established indication for statin therapy (atherosclerotic cardiovascular disease, familial hyperlipidemia).
• Chronic debilitating diseases as diabetes mellitus, chronic liver disease, chronic kidney disease, and hematological disorders.
• Pregnancy/lactation.
• Known hypersensitivity to statins.
• Unable or refuse to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Statin group; which includes 40 chronic obstructive pulmonary disease cases (grade E) who received statin (atorvastatin with a dose of 20 mg daily as an add-on therapy for 6 months)	Drug: Statin; patients received statin (atorvastatin with a dose of 20 mg daily as an add-on therapy for 6 months).
Active Comparator: non Statin group; which includes 40 COPD (grade E) cases who did not receive statin	Other: placepo intervention; patients didn't receive statin as in the statin group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of complete blood count	A Complete Blood Count (CBC) is measured using an automated hematology analyzer to quantify different components of blood. A brief description suitable for a research paper could be: Blood samples were collected in EDTA-anticoagulated tubes and analyzed using an automated hematology analyzer. The complete blood count (CBC) parameters, including hemoglobin concentration, red blood cell (RBC) count, white blood cell (WBC) count, hematocrit (HCT), platelet count, and red cell indices (MCV, MCH, MCHC), were measured according to the manufacturer's instructions. Quality control procedures were performed daily to ensure accuracy and reliability of results.	baseline - 1 month - 6 months
assessment of Liver function	Blood samples were collected and centrifuged to obtain serum. Liver function tests were performed using an automated biochemistry analyzer according to the manufacturer's instructions. The measured parameters included alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), total and direct bilirubin, serum albumin, and total protein. Internal quality control procedures were carried out to ensure the accuracy and reliability of the results.	baseline - 1 month - 6 months
assessment of Kidney function	Blood samples were collected and centrifuged to obtain serum. Kidney function tests were performed using an automated biochemistry analyzer according to the manufacturer's instructions. The measured parameters included serum creatinine, blood urea (urea nitrogen), and uric acid. Estimated glomerular filtration rate (eGFR) was calculated using an appropriate equation. Internal quality control procedures were applied to ensure the accuracy and reliability of the results.	baseline - 1 month - 6 months
assessment of Erythrocyte sedimentation rate.	"For measurement of erythrocyte sedimentation rate (ESR), venous blood was collected in an anticoagulant-containing tube and transferred into a vertically positioned Westergren tube. The distance that red blood cells sedimented after 1 hour was recorded in mm/hour."	baseline - 1 month - 6 months
assessment of C-reactive protein	"C-reactive protein (CRP) was measured from a venous blood sample using a standard laboratory immunoassay technique, and the value was recorded in mg/L as an indicator of systemic inflammation."	baseline - 1 month - 6 months
assessment of Serum eosinophil level.	"Serum eosinophil count was determined from venous blood samples using an automated hematology analyzer and expressed as cells per microliter (cells/µL)."	baseline - 1 month - 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of the delta change forced expiratory volume1 gradient	"The delta change in forced expiratory volume in one second (ΔFEV₁) was determined using spirometry as the difference between post-intervention and pre-intervention FEV₁ measurements."	baseline - 1 month - 6 months
assessment of Peak expiratory flow rate	"Peak expiratory flow rate (PEFR) was assessed by spirometry as the highest flow achieved during a forceful expiration following maximal inspiration."	baseline - 1 month - 6 months
assessment of degree of hyperinflation of lung	High-resolution computed tomography of the chest assesses the degree of hyperinflation by lung volumetry. The presence and degree of emphysema can be quantified using computed tomography. An emphysema index (volume fraction of the lung ≤ -950 Hounsfield Units >10% at full inspiration) was defined as having emphysema	baseline - 1 month - 6 months

Collaborators and Investigators

• Sponsor: Mohamed Salah El-Sayed

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): May 1, 2025
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: April 19, 2026
• First Submitted That Met QC Criteria: April 19, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 19, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Other Study ID Numbers: Mohamed-00012369

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No