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

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00792337
First received: November 14, 2008
Last updated: September 17, 2009
Last verified: September 2009
History of Changes

November 14, 2008
September 17, 2009
December 2008
August 2009   (final data collection date for primary outcome measure)
Sputum eosinophil [ Time Frame: 8 WEEKS ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00792337 on ClinicalTrials.gov Archive Site
  • FEV1 [ Time Frame: 8 WEEKS ] [ Designated as safety issue: No ]
  • PC20 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids in Asthma

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

To determine the additive effect of simvastatin on airway inflammation in ICS-treated patients with persistent asthma by measuring eosinophil counts in induced sputum
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: simvastatin
    10 mg per oral once daily for 8 weeks
    Other Name: zocor
  • Drug: B1-6-12
    1 table per day for 8 weeks
    Other Name: vitamin B1-6-12
  • Active Comparator: simvastatin
    simvastatin in combination with budesonide
    Intervention: Drug: simvastatin
  • Placebo Comparator: B1-6-12
    Budesonide in combination with B1-6-12
    Intervention: Drug: B1-6-12
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
September 2009
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00792337
004(II)/51
No
Kittipong Maneechotesuwan Associate Professor, Division of Respiratory Disease Faculty of Medicine Siriraj Hospital
Mahidol University
Not Provided
Principal Investigator: Kittipong - Maneechotesuwan, MD, PhD Faculty of Medicine Siriraj Hospital
Mahidol University
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP