Trial intelligence / Profile preview

Simvastatin in Asthma

NCT01266434Phase 3

Key facts

Status
Completed
Start
Jan 2011
Primary completion
Feb 2016
Countries
1
Sponsor
Mahidol University
Modality
Small Molecules
Conditions
asthma
01

Overview

Phase 3, randomised trial in asthma comparing Simvastatin with Placebo (2 arms). Primary endpoint: Sputum eosinophils at 8 weeks. Started Jan 2011; status: completed.

02

Design

2 arms
Study design
Randomized
  • Simvastatin

    Simvastatin 10 mg once daily for 8 weeks

  • Placebo

    Placebo (B1-6-12) 1 tablet once daily for 8 weeks

03

Who it enrols

Mild-to-moderate persistent asthmatics on inhaled corticosteroids with FEV1 >= 50% of predicted, excluding those with renal or liver disease, pregnancy, or recent oral corticosteroid use.

04

Endpoints

Primary

  • Sputum eosinophils

Secondary

  • Phosphorylated p38 MAPK in sputum cells

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