We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00792337
Recruitment Status : Completed
First Posted : November 17, 2008
Last Update Posted : September 11, 2013
Information provided by (Responsible Party):
Kittipong Maneechotesuwan, Mahidol University

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

Condition or disease Intervention/treatment Phase
Asthma Drug: simvastatin Drug: B1-6-12 Phase 3

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma
Study Start Date : December 2008
Primary Completion Date : August 2009
Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Simvastatin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: simvastatin
simvastatin in combination with budesonide
Drug: simvastatin
10 mg per oral once daily for 8 weeks
Other Name: zocor
Placebo Comparator: B1-6-12
Budesonide in combination with B1-6-12
Drug: B1-6-12
1 table per day for 8 weeks
Other Name: vitamin B1-6-12

Primary Outcome Measures :
  1. Sputum eosinophil [ Time Frame: 8 WEEKS ]

Secondary Outcome Measures :
  1. FEV1 [ Time Frame: 8 WEEKS ]
  2. PC20 [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00792337

Kittipong Maneechotesuwan
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Principal Investigator: Kittipong - Maneechotesuwan, MD, PhD Faculty of Medicine Siriraj Hospital

Responsible Party: Kittipong Maneechotesuwan, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT00792337     History of Changes
Other Study ID Numbers: 004(II)/51
First Posted: November 17, 2008    Key Record Dates
Last Update Posted: September 11, 2013
Last Verified: September 2009

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors