An interventional study of Statin and placepo intervention in Statin, Airway Disease and Chronic Obstructive Pulmonary Disease, sponsored by Mohamed Salah El-Sayed. Completed at 1 site in Egypt. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Mohamed Salah El-Sayed · Not applicable, Interventional, and Treatment
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.
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.
4,131 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 697 are open to participants now.
This study's enrollment of 80 is above the median of 70 across 2,926 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →This is the only study on the registry with Mohamed Salah El-Sayed as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
which includes 40 COPD (grade E) cases who did not receive statin
Other: placepo intervention
patients received statin (atorvastatin with a dose of 20 mg daily as an add-on therapy for 6 months).
patients didn't receive statin as in the statin group.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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."
Time frame: 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."
Time frame: 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)."
Time frame: baseline - 1 month - 6 months
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."
Time frame: 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."
Time frame: 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
Time frame: baseline - 1 month - 6 months
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive→