Clinical trial NCT00929734: Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease
Official title: Effect of ROsuvastatin Therapy on Peripheral Vasodilator Function, Inflammatory Markers and Pulmonary Function in Patients With StablE Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Inflammation
Atherosclerosis
Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Haukeland University Hospital
First posted: 2009-06-29
Enrollment: 99
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

* Stable COPD patients of both genders with no COPD exacerbations less than three weeks prior to inclusion
* COPD stage I to IV after the GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)
* Age between 40 and 80 years

Exclusion criteria:

* Diagnosed lung disease other than COPD, except chronic asthmatic bronchitis and mild bronchiectasis without or few physical signs (diagnosed by high resolution CT)
* History of or active coronary artery disease (CAD), cerebrovascular or peripheral vascular disease
* History of or clinically significant congestive heart failure, valvular heart disease, clinically significant arrhythmias or conduction delays
* History of uncontrolled arterial hypertension (defined as blood pressure above180/110 mmHg with or without the use of antihypertensive medication)
* Body mass index \>40kg/m2
* History of diabetes mellitus, measured fasting glucose \> 11 mmol/L
* History of Hypercholesterolemia, measured total cholesterol \> 8 mmol/L
* Known poliomyelitis, motor neurone disease, cranial or temporal arteritis, stroke or myopathy
* Neutropenia, anemia (Hb \< 8 g/100mL)
* History of chronic renal failure, serum creatinine \> 176 micromol/L (2.0mg/dL)
* Creatine kinase \> 3 times the upper limit of normal (ULN)
* Acute or chronic liver disease (serum transaminases \> 3 times the ULN)
* Pregnancy (oral examination and blood test prior to inclusion)
* Active abuse of drugs or alcohol, poor compliance anticipated
* Statin use within the last 4 weeks prior to study start or previously clear indication for statin use
* Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another hydroxymethylglutaryl-Coenzyme A-reductase inhibitor incl. Rosuvastatin
* History of malignant disease of any kind within 5 years prior to inclusion.
* History of uncontrolled hypothyroidism
* Participation in another pharmaceutical or medical device clinical trial study less than 4 weeks prior inclusion.
* Use concomitant of medications that are known to interact with Crestor. This includes the following medications: Warfarin and other coumarin (vitamin K antagonist) anticoagulants, Cyclosporin, Gemfibrozil and Antacid

Primary outcomes:
measure: Relative Change in Reactive Hyperemia Index (RHI)
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Relative Change in FEV1
timeFrame: Baseline to 3 months
measure: Relative Change in High-sensitivity C-reactive Protein
timeFrame: Baseline to 3 months
measure: Relative Change in Interleukin 6
timeFrame: Baseline to 3 months
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University Hospital
state: Akershus
Study officials:
affiliation: University Hospital, Akershus
name: Torbjørn Omland, PhD
role: PRINCIPAL_INVESTIGATOR
References: