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

NCT07549932 | Completed

• 1 other identifier: Mohamed-00012369
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Statin; Airway Disease; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (3)

• assessment of the delta change forced expiratory volume1 gradient

  baseline - 1 month - 6 months

• assessment of Peak expiratory flow rate

  baseline - 1 month - 6 months

• assessment of degree of hyperinflation of lung

  baseline - 1 month - 6 months

Study Arms (2)

Statin group

EXPERIMENTAL

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

non Statin group

ACTIVE COMPARATOR

which includes 40 COPD (grade E) cases who did not receive statin

Other: placepo intervention

Interventions

Statin DRUG

patients received statin (atorvastatin with a dose of 20 mg daily as an add-on therapy for 6 months).

Statin group

placepo intervention OTHER

patients didn't receive statin as in the statin group.

non Statin group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mohamed Salah El-Sayed: lead

Study Sites (1)

utpatient clinic and Inpatient quarters of the Thoracic Medicine Department of Mansoura University Hospitals

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 19, 2026
• First Posted: April 24, 2026
• Study Start: January 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: June 1, 2025
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

EG (1)