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

NCT00929734 | Completed Phase 2 Results DMC

• 1 other identifier: 2009A2
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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)

Keywords

Inflammation; Atherosclerosis; Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

  Baseline to 3 months

Study Arms (2)

Rosuvastatin

EXPERIMENTAL

Drug: Rosuvastatin

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rosuvastatin DRUG

10mg tablets, once daily in three months

Also known as: Hydroxymethylglutaryl-CoA Reductase Inhibitor

Rosuvastatin

Placebo DRUG

1 tablet, once daily in three months

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COPD stage I to IV after the GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)
• Age between 40 and 80 years

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• AstraZeneca: collaborator
• Haukeland University Hospital: collaborator

Study Sites (1)

Akershus University Hospital

Lørenskog, Akershus, 1478, Norway

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation; Atherosclerosis

Interventions

Rosuvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses

Results Point of Contact

• Title: Professor Torbjørn Omland
• Organization: University of Oslo

torbjorn.omland@medisin.uio.no

+47 40107050

Study Officials

• Torbjørn Omland, PhD

  University Hospital, Akershus

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: June 26, 2009
• First Posted: June 29, 2009
• Study Start: March 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: October 8, 2015
• Results First Posted: October 8, 2015

Record last verified: 2015-09

Locations

NO (1)