EUCTR2005-001466-14-GB
Active, not recruiting
Phase 1
A Proof of Concept Study to Investigate the use of Simvastatin as a Putative Anti-inflammatory Agent in Asthma - Simvastatin in Asthma
niversity of Dundee0 sites20 target enrollmentApril 19, 2005
ConditionsAsthma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Asthma
- Sponsor
- niversity of Dundee
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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
Outcomes
Primary Outcomes
Not specified
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