The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma

NCT ID: NCT01266434

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

simvastatin

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

10 mg once daily for 8 weeks

B1-6-12

Group Type PLACEBO_COMPARATOR

Simvastatin

Intervention Type DRUG

10 mg once daily for 8 weeks

B1-6-12

Intervention Type DRUG

1 tablet once daily for 8 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simvastatin

10 mg once daily for 8 weeks

Intervention Type DRUG

B1-6-12

1 tablet once daily for 8 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Zocor

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kittipong Maneechotesuwan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kittipong - Maneechotesuwan, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Division of Respiratory Disease and TB, Siriraj Hospital

Bangkoknoi, BKK, Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

si481/2010

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

TNF-alpha Directed Therapy in Asthma
NCT00278083 COMPLETED PHASE2
Study in Patients With Asthma
NCT00215397 COMPLETED PHASE2
Statin Treatment in Patients With Asthma
NCT00292201 TERMINATED PHASE2
Study in Patients With Asthma
NCT00215410 COMPLETED PHASE2