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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kittipong Maneechotesuwan, Mahidol University
ClinicalTrials.gov Identifier:
NCT00792337
First received: November 14, 2008
Last updated: September 10, 2013
Last verified: September 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Mahidol University:

Primary Outcome Measures:
  • Sputum eosinophil [ Time Frame: 8 WEEKS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • FEV1 [ Time Frame: 8 WEEKS ] [ Designated as safety issue: No ]
  • PC20 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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

ClinicalTrials.gov processed this record on April 20, 2014