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OpenTrials
Completed

NCT Number: NCT00463827

Effect of Statins on Asthma Control in Smokers With Asthma

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

atorvastatin

Drug

Matched placebo

Drug

Matched placebo

Primary outcomes

  1. Change in peak flow data

    Time frame: 4 weeks

Secondary outcomes

  1. sputum cell counts

    Time frame: 4 weeks and 8 weeks

  2. spirometry

    Time frame: 4 weeks and 8 weeks

  3. airway responsiveness to methacholine

    Time frame: 4 weeks and 8 weeks

  4. symptom scores

    Time frame: 4 weeks and 8 weeks

  5. Exhaled and alveolar NO

    Time frame: 4 weeks and 8 weeks

  6. Exacerbation rates

    Time frame: 4 and 8 weeks

  7. immunological tests in blood

    Time frame: 4 and 8 weeks

  8. ACQ score

    Time frame: 4 and 8 weeks

  9. AQLQ score

    Time frame: 4 and 8 weeks

  10. Safety issues

    Time frame: 4 and 8 weeks

Sponsors and collaborators

Lead sponsor

NHS Greater Clyde and Glasgow

Other

Collaborators

  • Medical Research Council
  • University of Glasgow

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 20, 2007
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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