StatinNCT07549932
Adjunctive Role of Statin Therapy on Airway Inflammation and Clinical Consequences of Chronic Obstructive Pulmonary Disease
A study testing Statin and placepo intervention in people with Statin and Airway Disease, run by Mohamed Salah El-Sayed at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Statin, Airway Disease, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Statin and placepo intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
utpatient clinic and Inpatient quarters of the Thoracic Medicine Department of Mansoura University Hospitals
Al Mansurah
About this study
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.
Read the 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.
- Being tested
- Statin, placepo intervention
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
patients received statin (atorvastatin with a dose of 20 mg daily as an add-on therapy for 6 months).
placepo interventionOther
patients didn't receive statin as in the statin group.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Statin |
| non Statin group | Active comparator | which includes 40 COPD (grade E) cases who did not receive statin Receives: Other: placepo intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 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)."
Measured: baseline - 1 month - 6 months
Secondary outcomes (3)
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."
Measured: 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."
Measured: 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
Measured: baseline - 1 month - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Jan 2024
- Primary completion1 May 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StatinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohamed Salah El-Sayed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohamed Salah El-Sayed, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549932
- Sponsor's protocol ID
- Mohamed-00012369
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Role of Statin Therapy on Airway Inflammation and Clinical Consequences of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT07549932
- Acronym / sponsor ID
- Mohamed-00012369
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mohamed Salah El-SayedUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Statin group | Experimental | Drug: Statinwhich 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) |
| non Statin group | Active comparator | Other: placepo interventionwhich includes 40 COPD (grade E) cases who did not receive statin |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Statinpatients received statin (atorvastatin with a dose of 20 mg daily as an add-on therapy for 6 months). | Drug | Statin group |
| placepo interventionpatients didn't receive statin as in the statin group. | Other | non Statin group |
Primary outcome
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.
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.
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.
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."
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."
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)."
3 secondary outcomes
assessment of the delta change forced expiratory volume1 gradient
Time frame: baseline - 1 month - 6 months
assessment of Peak expiratory flow rate
Time frame: baseline - 1 month - 6 months
assessment of degree of hyperinflation of lung
Time frame: baseline - 1 month - 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Statin and placepo intervention in people with Statin and Airway Disease, run by Mohamed Salah El-Sayed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of complete blood count (time frame: baseline - 1 month - 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.