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

NCT ID: NCT00929734

Last Updated: 2015-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-01-31

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Rosuvastatin

Group Type: EXPERIMENTAL

Rosuvastatin

Intervention Type: DRUG

10mg tablets, once daily in three months

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 tablet, once daily in three months

Interventions

Rosuvastatin

10mg tablets, once daily in three months

Intervention Type: DRUG

Placebo

1 tablet, once daily in three months

Intervention Type: DRUG

Other Intervention Names

Hydroxymethylglutaryl-CoA Reductase Inhibitor

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Torbjorn Omland

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Torbjørn Omland, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Akershus

Locations

Akershus University Hospital

Lørenskog, Akershus, Norway

Countries

Norway

Other Identifiers

2009A2

Identifier Type: -

Identifier Source: org_study_id