Randomised controlled trial to evaluate the effect of statins on asthma control of patients with chronic asthma.

INTERVENTION: Trade Name: Lipitor Product Name: Lipitor™ (atorvastatin ) Pharmaceutical Form: Tablet INN or Proposed INN: atorvastatin CAS Number: 134523‐00‐5 Other descriptive name: (HMG CoA) 3–hydroxy‐3methylglutaryl coenzyme A reductase inhibitor Concentration unit: mg milligram(s) Concentration type: equal Concentration number: once‐daily Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use CONDITION: Chronic Asthma PRIMARY OUTCOME: Main Objective: The principal objective of this randomised controlled trial is to test the hypothesis that statins improve asthma control of patients with chronic asthma. Primary end point(s): Improvement in the morning peak flow rates (PEF) following statin treatment compared to placebo. Secondary Objective: The secondary objectives are to assess changes in airway hyperreactivity and inflammation in asthmatics treated with statins compared to placebo. Secondary endpoints include changes in asthma symptom scores, exacerbation rates, spirometry, airway responsiveness to methacholine, sputum cell counts, exhaled nitric oxide, immunological tests in blood and asthma quality of life questionnaire. INCLUSION CRITERIA: 1. Asthma : This will be established symptomatically by episodic wheezing, chest tightness and/or dyspnoea and objectively confirmed by methacholine airway hyperresponsiveness or by evidence of variable airflow obstruction with an increase in FEV1 of > 12% following nebulised salbutamol (2.5mg) or diurnal peak flow variability of > 20% during the run‐in period of the study 2.Age range 18–70 years 3. Duration of asthma > 1 year and on stable medication for four weeks 4.Receiving regular inhaled steroid treatment (British Asthma Management Guidelines: step 2 only) 5. Symptomatic: defined as an asthma control questionnaire score of 1 (range 0‐6) prior to randomisation or use of inhaled beta2‐agonist on 5 or more days in week before randomisation or FEV1 reversibility >12% or diurnal peak flow variability of >20% during the run‐in period of the study 6. Written informed consent Are the trial subjects under 18? no Number of subjects for this age