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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792337
• Other study ID #: 004(II)/51
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2008
• Last updated: September 10, 2013
• Start date: December 2008
• Est. completion date: September 2009

Study information

• Verified date: September 2009
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• simvastatin
10 mg per oral once daily for 8 weeks
• B1-6-12
1 table per day for 8 weeks

Locations

Country	Name	City	State
Thailand	Kittipong Maneechotesuwan	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum eosinophil		8 WEEKS	No
Secondary	FEV1		8 WEEKS	No
Secondary	PC20		8 weeks	No