Effect of Statins on Asthma Control in Smokers With Asthma + Pilot Study of Effect of Statins on Lung Function in COPD - Full Text View

Sponsors and Collaborators:	NHS Greater Clyde and Glasgow University of Glasgow Medical Research Council
Information provided by:	NHS Greater Clyde and Glasgow
ClinicalTrials.gov Identifier:	NCT00463827

Purpose

Asthma is a chronic inflammatory condition of the lungs.

There is evidence that cigarette smoking can make asthma symptoms worse and that smokers with asthma do not respond as well to standard therapies as non-smokers.

Statins are drugs which are already used to lower cholesterol. They have also been shown to have some anti-inflammatory properties.

In this trial we will give a randomised group of smokers Atorvastatin and the remaining group a placebo or blank tablet. We will then monitor patients' responses in terms of peak flow data, symptom diaries, questionnaires and breathing tests.

Condition	Intervention	Phase
Asthma COPD Smoking	Drug: Atorvastatin Drug: atorvastatin Drug: matched placebo	Phase II

MedlinePlus related topics: Asthma Smoking Statins

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Statins on Asthma Control and Airway Inflammation in Smokers With Asthma: a Randomised Controlled Double-Blind Parallel Group Study + Pilot Study: Effect of Statins in Lung Function and Airway Inflammation in Patients With Chronic Obstructive Pulmonary Disease (COPD): a Randomised Controlled Double-Blind Parallel Group Study.

Further study details as provided by NHS Greater Clyde and Glasgow:

Primary Outcome Measures:

Change in peak flow data [ Time Frame: 8 weeks ]

Secondary Outcome Measures:

sputum cell counts [ Time Frame: 4 weeks and 8 weeks ]
spirometry [ Time Frame: 4 weeks and 8 weeks ]
airway responsiveness to methacholine [ Time Frame: 4 weeks and 8 weeks ]
symptom scores [ Time Frame: 4 weeks and 8 weeks ]
Exhaled and alveolar NO [ Time Frame: 4 weeks and 8 weeks ]
Exacerbation rates [ Time Frame: 8 weeks ]
immunological tests in blood [ Time Frame: 8 weeks ]

Estimated Enrollment:	80
Study Start Date:	August 2007
Estimated Study Completion Date:	January 2009

Arms	Assigned Interventions
2: Active Comparator Atorvastatin 40	Drug: Atorvastatin Drug: atorvastatin atorvastatin 40mg
placebo: Placebo Comparator matched placebo	Drug: matched placebo Matched placebo

Detailed Description:

Despite several studies, which have shown that smokers with asthma have more severe symptoms, accelerated decline in lung function and diminished response to treatment with inhaled and oral corticosteroids, more than 25% of asthmatics continue to smoke. Smoking cessation advice is often ineffective.

Statins are used as cholesterol lowering agents, however, there is now also evidence that they have additional anti-inflammatory effects which may be useful in treatment of smokers with asthma.

This is a randomised placebo controlled double-blind parallel group study.

Following screening to assess suitability for the study, patients will be randomised to treatment with either Atorvastatin 40mg or placebo (blank tablet)for 8 weeks.

After 4 weeks of treatment, all patients will be commenced on a low dose inhaled corticosteroid for the remainder of the study to assess whether treatment with statins can overcome steroid resistance in smokers with asthma.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of asthma for more than 1 year
Symptomatic asthma
Smoker with greater than 5 pack year history
On short acting bronchodilator only- although may have medication weaned if stable

Exclusion Criteria:

Ex-smokers or non-smokers
Patients already on statin therapy
Unstable asthma
Previous statin sensitivity or myopathy or myositis
On any medications known to interact with statins

Note separate entry criteria for pilot study of COPD patients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463827

Contacts

Contact: Georgina Braganza, MRCP	0141 211 3498	george_gsf@hotmail.com
Contact: Jane Lafferty	0141 211 3498	janelafferty1@yahoo.co.uk

Locations

United Kingdom
Gartnavel General Hospital	Recruiting
Glasgow, United Kingdom, G12 0YN
Contact: Georgina Braganza, MBCHB 0141 211 3498 george_gsf@hotmail.com
Principal Investigator: Neil Thomson, FRCP
Sub-Investigator: Georgina Braganza, MRCP
Sub-Investigator: Jane Lafferty
Sub-Investigator: Rekha Chaudhuri, MD MRCP

Sponsors and Collaborators

NHS Greater Clyde and Glasgow

University of Glasgow

Medical Research Council

Investigators

Principal Investigator:

Neil Thomson, FRCP

University of Glasgow

More Information

Unit website This link exits the ClinicalTrials.gov site

Study ID Numbers:	AR 003
Study First Received:	April 18, 2007
Last Updated:	April 7, 2008
ClinicalTrials.gov Identifier:	NCT00463827
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS Greater Clyde and Glasgow:

asthma
smokers
statin
atorvastatin
randomised

placebo
cigarette
blind
COPD

Study placed in the following topic categories:

Smoking
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate

Asthma
Atorvastatin
Respiratory Hypersensitivity
Inflammation
Pulmonary Disease, Chronic Obstructive

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