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The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma

Primary Purpose

Asthma

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

simvastatin

B1-6-12

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Kittipong Maneechotesuwan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

simvastatin

B1-6-12

Arm Description

simvastatin in combination with budesonide

Budesonide in combination with B1-6-12

Outcomes

Primary Outcome Measures

Sputum eosinophil

Secondary Outcome Measures

FEV1

PC20

Full Information

NCT ID

NCT00792337

First Posted

November 14, 2008

Last Updated

September 10, 2013

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT00792337

Brief Title

The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma

Official Title

The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

53 (Actual)

8. Arms, Groups, and Interventions

Arm Title

simvastatin

Arm Type

Active Comparator

Arm Description

simvastatin in combination with budesonide

Arm Title

B1-6-12

Arm Type

Placebo Comparator

Arm Description

Budesonide in combination with B1-6-12

Intervention Type

Drug

Intervention Name(s)

simvastatin

Other Intervention Name(s)

zocor

Intervention Description

10 mg per oral once daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

B1-6-12

Other Intervention Name(s)

vitamin B1-6-12

Intervention Description

1 table per day for 8 weeks

Primary Outcome Measure Information:

Title

Sputum eosinophil

Time Frame

8 WEEKS

Secondary Outcome Measure Information:

Title

FEV1

Time Frame

8 WEEKS

Title

PC20

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: He or she has FEV1 > 60% of predicted He or she requires less than 1000 mcg daily of beclomethasone or equivalent Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kittipong - Maneechotesuwan, MD, PhD

Organizational Affiliation

Faculty of Medicine Siriraj Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kittipong Maneechotesuwan

City

Bangkoknoi

State/Province

Bangkok

ZIP/Postal Code

10700

Country

Thailand

12. IPD Sharing Statement

Learn more about this trial

The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma

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