Airway Disease, Chronic Obstructive Pulmonary Disease, Statin
Conditions
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.
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.
Interventions
DRUGStatin
patients received statin (atorvastatin with a dose of 20 mg daily as an add-on therapy for 6 months).
OTHERplacepo intervention
patients didn't receive statin as in the statin group.
Sponsors
Mohamed Salah El-Sayed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| assessment of complete blood count | 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. |
| assessment of Liver function | 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. |
| assessment of Kidney function | 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. |
| assessment of Erythrocyte sedimentation rate. | 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." |
| assessment of C-reactive protein | 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." |
| assessment of Serum eosinophil level. | 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
| Measure | Time frame | Description |
|---|---|---|
| assessment of the delta change forced expiratory volume1 gradient | 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." |
| assessment of Peak expiratory flow rate | 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." |
| assessment of degree of hyperinflation of lung | 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 |
Countries
Egypt
Outcome results
None listed