NCT00126048

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for phase_2 asthma

Timeline
Completed

Started Jul 2005

Typical duration for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2005

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2005

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 18, 2010

Status Verified

September 1, 2008

Enrollment Period

2.2 years

First QC Date

June 30, 2005

Last Update Submit

March 17, 2010

Conditions

Asthma

Keywords

AtopyStatinAsthmamethacholineFEV1

Outcome Measures

Primary Outcomes (1)

  • Change in PEFR

    8 weeks of treatment

Secondary Outcomes (3)

  • Change in health-related quality of life (HR-QOL)

    8 weeks

  • Change in asthma control score (Juniper)

    8 weeks

  • Change in inflammatory markers

    8 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Oral atorvastatin 40mg

Drug: Atorvastatin

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AtorvastatinDRUG

40mg tablet

Also known as: Lipitor
1
PlaceboDRUG

Placebo tablet

2

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asthma Clinical Research Centre, Level 6, Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Location

Related Publications (1)

  • Hothersall E, McSharry C, Thomson NC. Potential therapeutic role for statins in respiratory disease. Thorax. 2006 Aug;61(8):729-34. doi: 10.1136/thx.2005.057976.

    PMID: 16877692BACKGROUND

Related Links

MeSH Terms

Conditions

Asthma

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Neil C Thomson, FRCP

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 30, 2005

First Posted

August 2, 2005

Study Start

July 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

March 18, 2010

Record last verified: 2008-09

Locations

GB(1)