Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— RODEO  

Official title:

Effect of ROsuvastatin Therapy on Peripheral Vasodilator Function, Inflammatory Markers and Pulmonary Function in Patients With StablE Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929734
• Other study ID #: 2009A2
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2009
• Last updated: September 7, 2015
• Start date: March 2010
• Est. completion date: January 2014

Study information

• Verified date: September 2015
• Source: University Hospital, Akershus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencyNorway: Data Protection Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Rosuvastatin
10mg tablets, once daily in three months
• Placebo
1 tablet, once daily in three months

Locations

Country	Name	City	State
Norway	Akershus University Hospital	Lørenskog	Akershus

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Akershus	AstraZeneca, Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline to 3 months	No
Secondary	Relative Change in FEV1		Baseline to 3 months	No
Secondary	Relative Change in High-sensitivity C-reactive Protein		Baseline to 3 months	No
Secondary	Relative Change in Interleukin 6		Baseline to 3 months	No