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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001466-14-GB

Enrollment

Registered

2005-04-19

Start date

2005-05-26

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

Trade Name: Serevent inhaler Product Name: Salmeterol xinafoate Pharmaceutical Form: Pressurised inhalation* INN or Proposed INN: Salmeterol xinafoate Concentration unit: µg microgram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult asthmatics (over 18 years) with stable mild to moderate asthma. FEV1 > 60% FENO > 20ppb MCh PC10 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

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

Design outcomes

Primary

Measure	Time frame
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)	—

Measure

Time frame

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)

—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026