Clinical trial NCT00463827: Effect of Statins on Asthma Control in Smokers With Asthma
Official title: Effect of Statins on Asthma Control and Airway Inflammation in Smokers With Asthma: a Randomised Controlled Double-blind Parallel Group Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
COPD
Smoking
Keywords: asthma
smokers
statin
atorvastatin
randomised
placebo
cigarette
blind
COPD
Lead sponsor: NHS Greater Clyde and Glasgow
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: Medical Research Council
First posted: 2007-04-20
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Change in peak flow data
timeFrame: 4 weeks
Secondary outcomes:
measure: sputum cell counts
timeFrame: 4 weeks and 8 weeks
measure: spirometry
timeFrame: 4 weeks and 8 weeks
measure: airway responsiveness to methacholine
timeFrame: 4 weeks and 8 weeks
measure: symptom scores
timeFrame: 4 weeks and 8 weeks
measure: Exhaled and alveolar NO
timeFrame: 4 weeks and 8 weeks
measure: Exacerbation rates
timeFrame: 4 and 8 weeks
measure: immunological tests in blood
timeFrame: 4 and 8 weeks
measure: ACQ score
timeFrame: 4 and 8 weeks
measure: AQLQ score
timeFrame: 4 and 8 weeks
measure: Safety issues
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Gartnavel General Hospital
Study officials:
affiliation: University of Glasgow
name: Neil Thomson, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Braganza G, Chaudhuri R, McSharry C, Weir CJ, Donnelly I, Jolly L, Lafferty J, Lloyd SM, Spears M, Mair F, Thomson NC. Effects of short-term treatment with atorvastatin in smokers with asthma--a randomized controlled trial. BMC Pulm Med. 2011 Apr 7;11:16. doi: 10.1186/1471-2466-11-16.