NCT01266434

Brief Summary

To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a signaling molecule for inflammation in inhaled steroid-treated asthmatics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_3 asthma

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

First Submitted

Initial submission to the registry

December 22, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

5.1 years

First QC Date

December 22, 2010

Last Update Submit

March 15, 2016

Conditions

Asthma

Keywords

moderate persistent asthmaInhaled corticosteroids

Outcome Measures

Primary Outcomes (1)

  • Sputum eosinophils

    To determine the additive effect of simvastatin on airway inflammation in ICS-treated patients with persistent asthma by measuring eosinophil counts in induced sputum and on lung function (FEV1)

    8 weeks

Secondary Outcomes (1)

  • Phosphorylated p38 MAPK in sputum cells

    8 weeks

Study Arms (2)

simvastatin

EXPERIMENTAL
Drug: Simvastatin

B1-6-12

PLACEBO COMPARATOR
Drug: SimvastatinDrug: B1-6-12

Interventions

SimvastatinDRUG

10 mg once daily for 8 weeks

Also known as: Zocor
B1-6-12simvastatin
B1-6-12DRUG

1 tablet once daily for 8 weeks

B1-6-12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild-to-moderate persistent asthmatics
  • FEV1 = OR \> 50% of predicted

You may not qualify if:

  • Previous history of renal disease or serum creatinine is more than 2 mg/dl.
  • Previous history of liver disease.
  • Pregnancy or lactation.
  • Are already receiving or are known to be allergic to statins or to have developed myositis.
  • Have an asthma exacerbation requiring treatment with oral corticosteroids during the 3 months prior to the commencement of study entry.
  • Being treated with immunosuppressive agents.
  • Unwilling to cooperate the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Respiratory Disease and TB, Siriraj Hospital

Bangkoknoi, BKK, 10700, Thailand

Location

MeSH Terms

Conditions

Asthma

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

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
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 22, 2010

First Posted

December 24, 2010

Study Start

January 1, 2011

Primary Completion

February 1, 2016

Study Completion

March 1, 2016

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

TH(1)