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OpenTrials
Completed

NCT Number: NCT00792337

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kittipong Maneechotesuwan

Bangkoknoi, Bangkok, 10700, Thailand

About this study

To determine the additive effect of simvastatin on airway inflammation in ICS-treated patients with persistent asthma by measuring eosinophil counts in induced sputum

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

simvastatin

Drug

10 mg per oral once daily for 8 weeks

Other names: zocor

B1-6-12

Drug

1 table per day for 8 weeks

Other names: vitamin B1-6-12

Primary outcomes

  1. Sputum eosinophil

    Time frame: 8 WEEKS

Secondary outcomes

  1. FEV1

    Time frame: 8 WEEKS

  2. PC20

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 17, 2008
Registry last updated
Sep 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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