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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00792337
First Posted: November 17, 2008
Last Update Posted: September 11, 2013
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.
Information provided by (Responsible Party):
Kittipong Maneechotesuwan, Mahidol University
  Purpose
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
  Eligibility

Information from the National Library of Medicine

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


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

Responsible Party: Kittipong Maneechotesuwan, Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT00792337     History of Changes
Other Study ID Numbers: 004(II)/51
First Submitted: November 14, 2008
First Posted: November 17, 2008
Last Update Posted: September 11, 2013
Last Verified: September 2009

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