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Effect of Statins on Asthma Control in Smokers With Asthma

Effect of Statins on Asthma Control and Airway Inflammation in Smokers With Asthma: a Randomised Controlled Double-blind Parallel Group Study

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00463827
Enrollment
71
Registered
2007-04-20
Start date
2007-08-31
Completion date
2009-06-30
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, COPD, Smoking

Keywords

asthma, smokers, statin, atorvastatin, randomised, placebo, cigarette, blind, COPD

Brief summary

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.

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.

Interventions

DRUGAtorvastatin
DRUGatorvastatin

atorvastatin 40mg

DRUGmatched placebo

Matched placebo

Sponsors

University of Glasgow
CollaboratorOTHER
Medical Research Council
CollaboratorOTHER_GOV
NHS Greater Clyde and Glasgow
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in peak flow data4 weeks

Secondary

MeasureTime frame
spirometry4 weeks and 8 weeks
airway responsiveness to methacholine4 weeks and 8 weeks
symptom scores4 weeks and 8 weeks
Exhaled and alveolar NO4 weeks and 8 weeks
sputum cell counts4 weeks and 8 weeks
immunological tests in blood4 and 8 weeks
ACQ score4 and 8 weeks
AQLQ score4 and 8 weeks
Safety issues4 and 8 weeks
Exacerbation rates4 and 8 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026