NCT02070133

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_3 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started May 2009

Longer than P75 for phase_3 chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 25, 2014

Completed
Last Updated

February 25, 2014

Status Verified

February 1, 2014

Enrollment Period

3.8 years

First QC Date

October 14, 2013

Last Update Submit

February 21, 2014

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic BronchitisStatinsEndothelial dysfunctionSystemic inflammationBODE indexUric acidVascular growth factors

Outcome Measures

Primary Outcomes (1)

  • Endothelial Dysfunction (Arterial Stiffness)

    Day 1 and day 84 (end of of week 12)

Secondary Outcomes (4)

  • Systemic inflammation

    Day 1 and day 84 (end of of week 12)

  • BODE index

    Day 1 and day 84 (end of of week 12)

  • Uric acid

    Day 1 and day 84 (end of of week 12)

  • Vascular growth factors

    Day 1 and day 84 (end of of week 12)

Study Arms (2)

Simvastatin

EXPERIMENTAL

Patients with COPD will receive simvastatin 40 mg once a day for 12 weeks

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR

Patients with COPD will receive placebo once a day during 12 weeks

Drug: Placebo

Interventions

SimvastatinDRUG

Simvastatin 40 mg once a day during 12 weeks

Simvastatin
PlaceboDRUG

Placebo once a day during 12 weeks

Placebo

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Fundacio Caubet-CIMERA

Bunyola, Balearic Islands, 07110, Spain

Location

Hospital Son Espases

Palma Mallorca, Balearic Islands, 07010, Spain

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, Chronic

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Ernest Sala, MD

    Hospital Son Espases, Palma Mallorca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

October 14, 2013

First Posted

February 25, 2014

Study Start

May 1, 2009

Primary Completion

March 1, 2013

Study Completion

May 1, 2013

Last Updated

February 25, 2014

Record last verified: 2014-02

Locations

ES(2)