This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Kittipong Maneechotesuwan, Mahidol University Identifier:
First received: November 14, 2008
Last updated: September 10, 2013
Last verified: September 2009
We hypothesize that simvastatin in combination with ICS might have synergistic anti-inflammatory effects on airway inflammation in asthmatic patients

Condition Intervention Phase
Asthma Drug: simvastatin Drug: B1-6-12 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Kittipong Maneechotesuwan, Mahidol University:

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

Secondary Outcome Measures:
  • FEV1 [ Time Frame: 8 WEEKS ]
  • PC20 [ Time Frame: 8 weeks ]

Enrollment: 53
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00792337

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

Responsible Party: Kittipong Maneechotesuwan, Professor, Mahidol University Identifier: NCT00792337     History of Changes
Other Study ID Numbers: 004(II)/51
Study First Received: November 14, 2008
Last Updated: September 10, 2013

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 processed this record on September 21, 2017