Effect of Statins on Asthma Control in Smokers With Asthma

This study has been completed.
Sponsor:
Collaborators:
University of Glasgow
Medical Research Council
Information provided by:
NHS Greater Clyde and Glasgow
ClinicalTrials.gov Identifier:
NCT00463827
First received: April 18, 2007
Last updated: January 15, 2010
Last verified: October 2007
  Purpose

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.


Condition Intervention Phase
Asthma
COPD
Smoking
Drug: Atorvastatin
Drug: atorvastatin
Drug: matched placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Statins on Asthma Control and Airway Inflammation in Smokers With Asthma: a Randomised Controlled Double-blind Parallel Group Study

Resource links provided by NLM:


Further study details as provided by NHS Greater Clyde and Glasgow:

Primary Outcome Measures:
  • Change in peak flow data [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • sputum cell counts [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • spirometry [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • airway responsiveness to methacholine [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • symptom scores [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • Exhaled and alveolar NO [ Time Frame: 4 weeks and 8 weeks ] [ Designated as safety issue: No ]
  • Exacerbation rates [ Time Frame: 4 and 8 weeks ]
  • immunological tests in blood [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: Yes ]
  • ACQ score [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]
  • AQLQ score [ Time Frame: 4 and 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: August 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Atorvastatin 40
Drug: Atorvastatin Drug: atorvastatin
atorvastatin 40mg
Placebo Comparator: placebo
matched placebo
Drug: matched placebo
Matched placebo

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00463827

Locations
United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
Sponsors and Collaborators
NHS Greater Clyde and Glasgow
University of Glasgow
Medical Research Council
Investigators
Principal Investigator: Neil Thomson, FRCP University of Glasgow
  More Information

Additional Information:
No publications provided by NHS Greater Clyde and Glasgow

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Glasgow Biomedicine, NHSGGlasgow
ClinicalTrials.gov Identifier: NCT00463827     History of Changes
Other Study ID Numbers: AR 003
Study First Received: April 18, 2007
Last Updated: January 15, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS Greater Clyde and Glasgow:
asthma
smokers
statin
atorvastatin
randomised
placebo
cigarette
blind
COPD

Additional relevant MeSH terms:
Asthma
Pulmonary Disease, Chronic Obstructive
Smoking
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Habits
Atorvastatin
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2014