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OpenTrials
Completed

NCT Number: NCT02070133

Efficacy of Simvastatin for the Treatment of COPD

To evaluate in patients with stable Chronic Obstructive Pulmonary Disease (COPD) the efficacy of statins (simvastatin) on: (1) endothelial function; (2) systemic inflammation; (3)BODE (B: body mass , O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index; (4) Uric acid; and, (5)vascular growth factors. Design: a 12 weeks randomized (1:1), double-blind, placebo control study. Population: 18 males with stable COPD between 40-80 years of age, exsmokers, with Forced expiratory volume in one second (FEV1) between 30 and 80% predicted post-bronchodilation.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Disease Disease Attributes Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

40 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Fundacio Caubet-CIMERA, Bunyola, Balearic Islands, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Stable COPD between 40-80 years of age, exsmokers, with FEV1 lower that 80% predicted post-bronchodilation.

Exclusion criteria

  • Severe co-morbidity (advanced-stage cancer, tuberculosis affecting more than a third of the total lung parenchyma, pneumonectomy, pneumoconiosis, left cardiac failure previously reported, known cardiopathy with ventricular dysfunction (ejection fraction < 45%) or any cardiovascular disease, Diabetes Mellitus treated with insulin, Hypercholesterolemia, Chronic inflammatory diseases (asthma, rheumatoid arthritis, lung fibrosis, autoimmune diseases), Treatment with systemic steroid, non steroidal anti-inflammatory drugs or stains within 3 months prior to inclusion.

Treatment and study plan

simvastatin

Drug

Simvastatin 40 mg once a day during 12 weeks

Placebo

Drug

Placebo once a day during 12 weeks

Primary outcomes

  1. Endothelial Dysfunction (Arterial Stiffness)

    Time frame: Day 1 and day 84 (end of of week 12)

Secondary outcomes

  1. Systemic inflammation

    Time frame: Day 1 and day 84 (end of of week 12)

  2. BODE index

    Time frame: Day 1 and day 84 (end of of week 12)

  3. Uric acid

    Time frame: Day 1 and day 84 (end of of week 12)

  4. Vascular growth factors

    Time frame: Day 1 and day 84 (end of of week 12)

Sponsors and collaborators

Lead sponsor

Hospital Universitari Son Dureta

Other

Collaborators

  • Cimera
  • Fundació d'investigació Sanitària de les Illes Balears

Registry information

Official study title

Pilot Study on the Efficacy of Statins for the Treatment of Chronic Obstructive Pulmonary Disease

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 25, 2014
Registry last updated
Feb 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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