Trial to Evaluate the Effect of Statins on Asthma Control of Patients With Chronic Asthma

This study has been completed.
Sponsor:
Collaborators:
NHS Greater Glasgow and Clyde
Asthma UK
NHS Greater Clyde and Glasgow
Information provided by:
University of Glasgow
ClinicalTrials.gov Identifier:
NCT00126048
First received: June 30, 2005
Last updated: March 17, 2010
Last verified: September 2008
  Purpose

Statins are the most common type of cholesterol-lowering drugs used in clinical practice. Recent research suggests that they may also have anti-inflammatory properties, in particular by inhibition of an important inflammatory cell called a T lymphocyte. Asthma is characterised by chronic inflammation in the airways, which is thought to be regulated by the activity of T lymphocytes. The investigators have found the anti-inflammatory activity of a statin drug in an experimental model of allergic asthma and they have recently shown the beneficial effects of a statin, atorvastatin, in patients with rheumatoid arthritis. These findings demonstrate the therapeutic potential of statin-sensitive pathways in allergic airways disease. The investigators plan to perform a "proof of concept" study to determine the effectiveness of statin therapy in asthma. This randomised controlled trial will test the hypothesis that statins improve asthma control of patients with chronic asthma. The study will be a 22-week randomised controlled trial comparing the effect on asthma control of oral atorvastatin with that of a matched placebo. Each treatment will be administered for 8 weeks separated by a 6-week washout period. A total of 52 allergic asthmatic patients will be recruited to ensure that 44 patients complete the study. The investigators will examine the effect of statin therapy on lung function, symptom scores, exacerbation rates, as well as on the measurement of airway inflammation in sputum and in the blood. This study will determine the benefit of atorvastatin as an add-on therapy in asthma and establish if statins might have a role in asthma management.


Condition Intervention Phase
Asthma
Drug: Atorvastatin
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial to Evaluate the Effect of Statins on Asthma Control of Patients With Chronic Asthma

Resource links provided by NLM:


Further study details as provided by University of Glasgow:

Primary Outcome Measures:
  • Change in PEFR [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in health-related quality of life (HR-QOL) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in asthma control score (Juniper) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Change in inflammatory markers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: July 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Oral atorvastatin 40mg
Drug: Atorvastatin
40mg tablet
Other Name: Lipitor
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo tablet

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of asthma: This will be established symptomatically by episodic wheezing, chest tightness and/or dyspnoea and objectively confirmed by methacholine airway hyperresponsiveness or by evidence of variable airflow obstruction with an increase in FEV1 of > 12% following nebulised salbutamol (2.5mg) or diurnal peak flow variability of > 20% for 3 days in a week (with a minimum change of 60 L) during the run-in period of the study (BTS).
  • Age range of 18-70 years
  • Duration of asthma > 1 year and on stable medication for 4 weeks
  • Receiving regular inhaled steroid treatment (≤ 1000mcg Beclomethasone equivalent daily) and no other medication for their asthma other than a short-acting bronchodilator.
  • Symptomatic, defined as an asthma control questionnaire score of 1 (range 0-6) prior to randomisation or use of inhaled beta2-agonist on 5 or more days in the week before randomisation or FEV1 reversibility >12% or diurnal peak flow variability of >20% during the run-in period of the study for at least 3 days of a week.
  • Stable asthma medication for at least 4 weeks prior to randomisation
  • Written informed consent

Exclusion Criteria:

  • Inability to demonstrate correct use of peak flow meter after instruction
  • Current smokers or ex-smokers of < 1 year or ex-smokers who have smoked > 5 pack years.
  • Patients with unstable asthma, defined as the presence of 1 or more of the following events in the month prior to randomisation: *emergency/'out of hours' visits of patients to the GP; *GP visit to patient at home; *A & E hospital attendance; *hospital admission.
  • Patients in whom cardiovascular risk requires statin therapy
  • Any known sensitivity or adverse reaction to statin, or previous evidence of myopathy or myositis plus creatinine kinase and liver function tests > x2 upper limit of normal range.
  • Non-atopic asthma (specific IgE skin test negative to common allergens) [skin test wheal </= 3mm over negative control saline]
  • Patients who show specific IgE sensitivity or are skin test positive to grass pollen allergen will not be recruited from mid May to the end of July (grass allergen season in the United Kingdom [UK]).
  • Pregnancy/lactation. Patients who require medications known to interact with statins, such as azole antifungal agents, erythromycin, clarithromycin, cyclosporine, gemfibrozil, verapamil and amiodarone.
  • Inability to fully comprehend the patient information sheet.
  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: NCT00126048

Locations
United Kingdom
Asthma Clinical Research Centre, Level 6, Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
Sponsors and Collaborators
University of Glasgow
NHS Greater Glasgow and Clyde
Asthma UK
NHS Greater Clyde and Glasgow
Investigators
Principal Investigator: Neil C Thomson, FRCP University of Glasgow
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00126048     History of Changes
Other Study ID Numbers: AR-001, Grant number:04/015, R&D:WN04RM024, Ethics committee:04/SO709/86
Study First Received: June 30, 2005
Last Updated: March 17, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Glasgow:
Atopy
Statin
Asthma
methacholine
FEV1

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

ClinicalTrials.gov processed this record on September 30, 2014