A Proof of Concept Study to Investigate the use of Simvastatin as a Putative Anti-inflammatory Agent in Asthma - Simvastatin in Asthma

Phase 1

Conditions: Asthma

Registration Number: EUCTR2005-001466-14-GB

Lead Sponsor: niversity of Dundee

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

Adult asthmatics (over 18 years) with stable mild to moderate asthma.
FEV1 > 60%
FENO > 20ppb
MCh PC10 < 2mg/mL
Induced sputum eosinophil count >3%
Ability to perform tests and remain compliant with protocol
Good inhaler technique
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Potential or actual contra-indication to Simvastatin in particular liver disease, renal failure, current or previous excess alcohol intake, elevated CK, pregnancy and concomitant use of medications known to interact adversly with simvastatin.
Known or suspoected hypersensitivity to any of the other IMP's
Inability to to provide informed consent
Recent respiratory tract infection
Recent use of oral corticosteroids
Significant concomitant respiratory disease
Current smokers
Any other condition that may, in the opinion of the investigators, endanger the health or safety of the participant

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether simvastatin (a drug principally used in patients with hyperlipidaemia) has beneficial anti-inflammatory effects in patients with asthma. It is increasingly well validated that statins in general have an anti-inflammatory role, and a recent study has demonstrated this in a murine model of asthma. The intention is to trial this in humans;Secondary Objective: To determine whether simvastatin has an effect on bronchial hyperresponsiveness in asthmatic patients.;Primary end point(s): Change in inflammation of the lower respiratory tract as measured by exhaled nitric oxide (a surrogate marker)

Secondary Outcome Measures