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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Haukeland University Hospital | OTHER |
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The purpose of this study is to investigate whether rosuvastatin improves measures of endothelial function, decreases measures of inflammation, and improves pulmonary function in patients with stable chronic obstructive pulmonary disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rosuvastatin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug | 10mg tablets, once daily in three months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change in Reactive Hyperemia Index (RHI) | Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment. | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Change in FEV1 | Baseline to 3 months | |
| Relative Change in High-sensitivity C-reactive Protein | Baseline to 3 months | |
| Relative Change in Interleukin 6 |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Torbjørn Omland, PhD | University Hospital, Akershus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akershus University Hospital | Lørenskog | Akershus | 1478 | Norway |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rosuvastatin | Rosuvastatin: 10mg tablets, once daily in three months |
| FG001 | Placebo | Placebo: 1 tablet, once daily in three months |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Complete case population
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| ID | Title | Description |
|---|---|---|
| BG000 | Rosuvastatin | Rosuvastatin 10mg tablet |
| BG001 | Placebo | Placebo tablet |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relative Change in Reactive Hyperemia Index (RHI) | Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment. | Complete case analysis | Posted | Mean | 95% Confidence Interval | percent change | Baseline to 3 months |
|
3 months
Data are presented for all patients with adverse event registration (patient diary).
The 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data.
2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rosuvastatin | Rosuvastatin: 10mg tablets, once daily in three months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Hospitalization for AECOPD |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AECOPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Torbjørn Omland | University of Oslo | +47 40107050 | torbjorn.omland@medisin.uio.no |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D007249 | Inflammation |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| D019161 | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Placebo | Drug | 1 tablet, once daily in three months |
|
| Baseline to 3 months |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Diastolic blood pressure | Mean | Standard Deviation | mmHg |
|
| Heart rate | Mean | Standard Deviation | beats/min |
|
| History of hypertension | Number | participants |
|
| History of asthma | Number | participants |
|
| Pack-years | Number of packs of cigarettes smoked per day by the number of years the person has smoked | Mean | Standard Deviation | pack-years |
|
| Current smoking | Number | participants |
|
| Haemoglobin | Mean | Standard Deviation | g/dl |
|
| Estimated Glomerular Filtration Rate (eGFR) | Renal function as calculated by the Cockcroft-Gault formula ((140- age) × bodyweight/serum creatinine) (× 0.85 for women)) | Mean | Standard Deviation | ml/min |
|
| Leucocyte count | Mean | Standard Deviation | cells*10^9/L |
|
| High-sensitivity C-reactive protein | Acute-phase reactant used in cardiovascular risk assessment | Median | Inter-Quartile Range | mg/L |
|
| Interleukin 6 | Median | Inter-Quartile Range | pg/mL |
|
| Glucose | Mean | Standard Deviation | mmol/L |
|
| Cholesterol | Mean | Standard Deviation | mmol/L |
|
| LDL-C | Mean | Standard Deviation | mmol/L |
|
| HDL-C | Mean | Standard Deviation | mmol/L |
|
| Triglycerides | Mean | Standard Deviation | mmol/L |
|
| Forced expiratory volume at one second (FEV1) | Mean | Standard Deviation | Liter |
|
| FEV1, % of predicted | Mean | Standard Deviation | Percent predicted value |
|
| FEV1/FVC | Forced vital capacity (FVC) | Mean | Standard Deviation | Percent of FVC |
|
| Antihypertensive treatment | Number | participants |
|
| Inhaled corticosteroids | including long acting beta agonists (LABA) | Number | participants |
|
| Long acting beta agonists | Number | participants |
|
| Long acting muscarinic antagonists | Number | participants |
|
| Anti-inflammatory treatment | Number | participants |
|
| Oestrogen treatment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Relative Change in FEV1 | Complete case analysis | Posted | Mean | 95% Confidence Interval | percent change | Baseline to 3 months |
|
|
|
|
| Secondary | Relative Change in High-sensitivity C-reactive Protein | Complete case analysis | Posted | Median | Inter-Quartile Range | percent change | Baseline to 3 months |
|
|
|
|
| Secondary | Relative Change in Interleukin 6 | Complete case analysis | Posted | Median | Inter-Quartile Range | percent change | Baseline to 3 months |
|
|
|
|
| 4 |
| 47 |
| 12 |
| 47 |
| EG001 | Placebo | Placebo: 1 tablet, once daily in three months | 3 | 49 | 21 | 49 |
|
| Hypophysis apoplexia | Vascular disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
|
| Nausea | Nervous system disorders | Systematic Assessment |
|
| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Orthostatic vertigo | Nervous system disorders | Systematic Assessment |
|
| Migraine | Nervous system disorders | Systematic Assessment |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
|
| Ankle edema | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Headache | Vascular disorders | Systematic Assessment |
|
| Urinary retension | Renal and urinary disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Cold | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Atrial flutter | Cardiac disorders | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000924 | Anticholesteremic Agents |
| D000960 | Hypolipidemic Agents |
| D000963 | Antimetabolites |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004791 | Enzyme Inhibitors |
| D057847 | Lipid Regulating Agents |
| D045506 | Therapeutic Uses |