NCT01944176

Brief Summary

Airway inflammation is partly driven by Th17 and Th17-polarizing cytokines that is steroid-resistant. Statins could suppress IL-17 cytokines in other diseases such as atherosclerosis and multiple sclerosis in mouse model. The investigators hypothesize that statins might provide anti-inflammatory benefit of suppressing IL-17 cytokines in COPD patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

September 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 17, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

11 months

First QC Date

September 10, 2013

Last Update Submit

March 15, 2016

Conditions

COPD

Keywords

COPDStatinsCytokines

Outcome Measures

Primary Outcomes (1)

  • Sputum cytokines

    Up to 4 weeks

Secondary Outcomes (2)

  • FEV1

    Up to 4 weeks

  • Sputum neutrophils

    Up to 4 weeks

Study Arms (2)

Simvastatin

EXPERIMENTAL

simvastatin 20 mg/d is randomized to treat COPD patients for 4 weeks

Drug: simvastatin, placebo

B1-6-12

PLACEBO COMPARATOR

B1-6-12 one tablet a day is randomized to give to COPD patients for 4 weeks

Drug: simvastatin, placebo

Interventions

simvastatin, placeboDRUG
Also known as: Bestatin, B1-6-12
B1-6-12Simvastatin

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stable COPD without an exacerbation within 3 months prior to study entry
  • mild, moderate and severe COPD with or without treatments, regardless of COPD medications

You may not qualify if:

  • Concomitant other chronic lung diseases including with TB and malignancy
  • HIV
  • Being on immunosuppressive drugs and systemic corticosteroids
  • Dyslipidemic patients with recent cardiovascular or cerebrovascular disease within 6 month prior to study entry
  • Cognitive impairment
  • Currently on macrolides, azole anti-fungal agents, amiodarone and amlodipine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, BKK, 10700, Thailand

Location

Related Publications (1)

  • Maneechotesuwan K, Wongkajornsilp A, Adcock IM, Barnes PJ. Simvastatin Suppresses Airway IL-17 and Upregulates IL-10 in Patients With Stable COPD. Chest. 2015 Nov;148(5):1164-76. doi: 10.1378/chest.14-3138.

    PMID: 26043025DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Simvastatinubenimex

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Kittipong Maneechotesuwan, MD., PhD.

    Siriraj Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 17, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

TH(1)