Effect of Statins on Asthma Control in Smokers With Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Asthma COPD Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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2

Atorvastatin 40

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

atorvastatin

Intervention Type DRUG

atorvastatin 40mg

placebo

matched placebo

Group Type PLACEBO_COMPARATOR

matched placebo

Intervention Type DRUG

Matched placebo

Interventions

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Atorvastatin

Intervention Type DRUG

atorvastatin

atorvastatin 40mg

Intervention Type DRUG

matched placebo

Matched placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No