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Completed

NCT Number: NCT07549932

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Al Mansurah, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Statin

Drug

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

placepo intervention

Other

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

Primary outcomes

  1. assessment of complete blood count

    Time frame: baseline - 1 month - 6 months

    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.

  2. assessment of Liver function

    Time frame: baseline - 1 month - 6 months

    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.

  3. assessment of Kidney function

    Time frame: baseline - 1 month - 6 months

    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.

  4. assessment of Erythrocyte sedimentation rate.

    Time frame: baseline - 1 month - 6 months

    "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."

  5. assessment of C-reactive protein

    Time frame: baseline - 1 month - 6 months

    "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."

  6. assessment of Serum eosinophil level.

    Time frame: baseline - 1 month - 6 months

    "Serum eosinophil count was determined from venous blood samples using an automated hematology analyzer and expressed as cells per microliter (cells/µL)."

Secondary outcomes

  1. assessment of the delta change forced expiratory volume1 gradient

    Time frame: baseline - 1 month - 6 months

    "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."

  2. assessment of Peak expiratory flow rate

    Time frame: baseline - 1 month - 6 months

    "Peak expiratory flow rate (PEFR) was assessed by spirometry as the highest flow achieved during a forceful expiration following maximal inspiration."

  3. assessment of degree of hyperinflation of lung

    Time frame: baseline - 1 month - 6 months

    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

Sponsors and collaborators

Lead sponsor

Mohamed Salah El-Sayed

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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