Trial to Evaluate the Effect of Statins on Asthma Control of Patients With Chronic Asthma - Full Text View

Sponsors and Collaborators:	University of Glasgow NHS Greater Glasgow and Clyde Asthma UK NHS Greater Clyde and Glasgow
Information provided by:	University of Glasgow
ClinicalTrials.gov Identifier:	NCT00126048

Purpose

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 an important inflammatory cell called a T lymphocyte. Asthma is characterised by chronic inflammation in the airways, which is thought to be regulated by the activity of T lymphocytes. The investigators have found the anti-inflammatory activity of a statin drug in an experimental model of allergic asthma and they have recently shown the beneficial effects of a statin, atorvastatin, in patients with rheumatoid arthritis. These findings demonstrate the therapeutic potential of statin-sensitive pathways in allergic airways disease. The investigators plan to perform a "proof of concept" study to determine the effectiveness of statin therapy in asthma. This randomised controlled trial will test the hypothesis that statins improve asthma control of patients with chronic asthma. The study will be a 22-week randomised controlled trial comparing the effect on asthma control of oral atorvastatin with that of a matched placebo. Each treatment will be administered for 8 weeks separated by a 6-week washout period. A total of 52 allergic asthmatic patients will be recruited to ensure that 44 patients complete the study. The investigators will examine the effect of statin therapy on lung function, symptom scores, exacerbation rates, as well as on the measurement of airway inflammation in sputum and in the blood. This study will determine the benefit of atorvastatin as an add-on therapy in asthma and establish if statins might have a role in asthma management.

Condition	Intervention	Phase
Asthma	Drug: Atorvastatin Drug: Placebo	Phase II Phase III

MedlinePlus related topics: Asthma Statins

Drug Information available for: Atorvastatin Atorvastatin calcium Methacholine Methacholine chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Randomised Controlled Trial to Evaluate the Effect of Statins on Asthma Control of Patients With Chronic Asthma

Further study details as provided by University of Glasgow:

Primary Outcome Measures:

Change in PEFR [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in health-related quality of life (HR-QOL) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change in asthma control score (Juniper) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Change in inflammatory markers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment:	54
Study Start Date:	July 2005
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Oral atorvastatin 40mg	Drug: Atorvastatin 40mg tablet
2: Placebo Comparator Placebo	Drug: Placebo Placebo tablet

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Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126048

Locations

United Kingdom
Asthma Clinical Research Centre, Level 6, Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN

Sponsors and Collaborators

University of Glasgow

NHS Greater Glasgow and Clyde

Asthma UK

NHS Greater Clyde and Glasgow

Investigators

Principal Investigator:

Neil C Thomson, FRCP

University of Glasgow

More Information

University of Glasgow Asthma Research Unit website This link exits the ClinicalTrials.gov site

Prof Thomson's section of Glasgow Uni webpages This link exits the ClinicalTrials.gov site

Publications:

Hothersall E, McSharry C, Thomson NC. Potential therapeutic role for statins in respiratory disease. Thorax. 2006 Aug;61(8):729-34. Review.

Study ID Numbers:	AR-001, Grant number:04/015, R&D:WN04RM024, Ethics committee:04/SO709/86
Study First Received:	June 30, 2005
Last Updated:	September 11, 2008
ClinicalTrials.gov Identifier:	NCT00126048
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Glasgow:

Atopy
Statin
Asthma
methacholine
FEV1

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Methacholine Chloride

Hypersensitivity, Immediate
Asthma
Atorvastatin
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Bronchial Diseases
Therapeutic Uses

Antilipemic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009