Effect of Statins on Asthma Control in Smokers With Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00463827
• Other study ID #: AR 003
• Status: Completed
• Phase: Phase 2
• First received: April 18, 2007
• Last updated: March 27, 2017
• Start date: August 2007
• Est. completion date: June 2009

Study information

• Verified date: March 2017
• Source: NHS Greater Clyde and Glasgow
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• COPD
• Smoking

Intervention

Drug:
• Atorvastatin

• atorvastatin
atorvastatin 40mg
• matched placebo
Matched placebo

Locations

Country	Name	City	State
United Kingdom	Gartnavel General Hospital	Glasgow

Sponsors (3)

Lead Sponsor	Collaborator
NHS Greater Clyde and Glasgow	Medical Research Council, University of Glasgow

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in peak flow data		4 weeks
Secondary	sputum cell counts		4 weeks and 8 weeks
Secondary	spirometry		4 weeks and 8 weeks
Secondary	airway responsiveness to methacholine		4 weeks and 8 weeks
Secondary	symptom scores		4 weeks and 8 weeks
Secondary	Exhaled and alveolar NO		4 weeks and 8 weeks
Secondary	Exacerbation rates		4 and 8 weeks
Secondary	immunological tests in blood		4 and 8 weeks
Secondary	ACQ score		4 and 8 weeks
Secondary	AQLQ score		4 and 8 weeks
Secondary	Safety issues		4 and 8 weeks

External Links

•   Unit website