Status:
COMPLETED
Trial to Evaluate the Effect of Statins on Asthma Control of Patients With Chronic Asthma
Lead Sponsor:
University of Glasgow
Collaborating Sponsors:
NHS Greater Glasgow and Clyde
Asthma UK
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
Brief Summary
Statins are the most common type of cholesterol-lowering drugs used in clinical practice. Recent research suggests that they may also have anti-inflammatory properties, in particular by inhibition of ...
Detailed Description
Study Design: The study will be a 24-week randomised double blind crossover study comparing the effect on asthma control of oral atorvastatin therapy (40 mg daily) with that of a matched placebo. Eac...
Eligibility Criteria
Inclusion
- Diagnosis of 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% for 3 days in a week (with a minimum change of 60 L) during the run-in period of the study (BTS).
- Age range of 18-70 years
- Duration of asthma \> 1 year and on stable medication for 4 weeks
- Receiving regular inhaled steroid treatment (≤ 1000mcg Beclomethasone equivalent daily) and no other medication for their asthma other than a short-acting bronchodilator.
- 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 the week before randomisation or FEV1 reversibility \>12% or diurnal peak flow variability of \>20% during the run-in period of the study for at least 3 days of a week.
- Stable asthma medication for at least 4 weeks prior to randomisation
- Written informed consent
Exclusion
- Inability to demonstrate correct use of peak flow meter after instruction
- Current smokers or ex-smokers of \< 1 year or ex-smokers who have smoked \> 5 pack years.
- Patients with unstable asthma, defined as the presence of 1 or more of the following events in the month prior to randomisation: \*emergency/'out of hours' visits of patients to the GP; \*GP visit to patient at home; \*A \& E hospital attendance; \*hospital admission.
- Patients in whom cardiovascular risk requires statin therapy
- Any known sensitivity or adverse reaction to statin, or previous evidence of myopathy or myositis plus creatinine kinase and liver function tests \> x2 upper limit of normal range.
- Non-atopic asthma (specific IgE skin test negative to common allergens) \[skin test wheal \</= 3mm over negative control saline\]
- Patients who show specific IgE sensitivity or are skin test positive to grass pollen allergen will not be recruited from mid May to the end of July (grass allergen season in the United Kingdom \[UK\]).
- Pregnancy/lactation. Patients who require medications known to interact with statins, such as azole antifungal agents, erythromycin, clarithromycin, cyclosporine, gemfibrozil, verapamil and amiodarone.
- Inability to fully comprehend the patient information sheet.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00126048
Start Date
July 1 2005
End Date
September 1 2007
Last Update
March 18 2010
Active Locations (1)
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1
Asthma Clinical Research Centre, Level 6, Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN