NCT00792337

Brief Summary

We hypothesize that simvastatin in combination with ICS might have synergistic anti-inflammatory effects on airway inflammation in asthmatic patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Dec 2008

Shorter than P25 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

November 14, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed
14 days until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 11, 2013

Status Verified

September 1, 2009

Enrollment Period

8 months

First QC Date

November 14, 2008

Last Update Submit

September 10, 2013

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Sputum eosinophil

    8 WEEKS

Secondary Outcomes (2)

  • FEV1

    8 WEEKS

  • PC20

    8 weeks

Study Arms (2)

simvastatin

ACTIVE COMPARATOR

simvastatin in combination with budesonide

Drug: simvastatin

B1-6-12

PLACEBO COMPARATOR

Budesonide in combination with B1-6-12

Drug: B1-6-12

Interventions

simvastatinDRUG

10 mg per oral once daily for 8 weeks

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

1 table per day for 8 weeks

Also known as: vitamin B1-6-12
B1-6-12

Eligibility Criteria

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

You may qualify if:

  • He or she has FEV1 \> 60% of predicted
  • He or she requires less than 1000 mcg daily of beclomethasone or equivalent

You may not qualify if:

  • He or she had previous history of renal disease or serum creatinine more than 2 mg/dL
  • He or she had previous history of liver disease
  • She is pregnant or during lactation
  • He or she has already received statins or is allergic to statins or has developed myositis.
  • He or she has an asthma exacerbation and requires treatment with oral corticosteroids during the 3 months prior to the commencement of study entry.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kittipong Maneechotesuwan

Bangkoknoi, Bangkok, 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

November 14, 2008

First Posted

November 17, 2008

Study Start

December 1, 2008

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

September 11, 2013

Record last verified: 2009-09

Locations

TH(1)