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

• Conditions: Chronic Asthma

• Registration Number: EUCTR2005-000691-41-GB
• Lead Sponsor: Greater Glasgow Health Board, North Glasgow University Hospitals Division

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-03-17
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 52

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 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

1. Inability to demonstrate correct use of peak flow meter after instruction
2. Current smokers or ex-smokers of < 1 year or ex-smokers who have smoked > 5 pack years.
3. Asthma exacerbation in the month prior to randomisation [Emergency/‘out of hours’ visit of patients to the GP; GP visit to patient at home; A & E hospital attendance; hospital admission]
4. Patients in whom cardiovascular risk requires statin therapy
5. Any known sensitivity to statin, or previous evidence of myopathy or myositis plus creatinine kinase and liver function tests 6. Non-atopic asthma
7. Patients who show specific IgE sensitivity or are skin test positive to grass pollen allergen will not be recruited from mid May to end of July (grass allergen season in UK)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;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.;Primary end point(s): Improvement in the morning peak flow rates (PEF) following statin treatment compared to placebo.