Effect of statins on asthma control and airway inflammation in smokers with asthma - Effect of statins in smokers with asthma

Phase 1

• Conditions: Chronic Asthma (smokers),COPD.; MedDRA version: 8.1 Level: LLT Classification code 10003553 Term: Asthma; MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD

• Registration Number: EUCTR2006-003103-39-GB
• Lead Sponsor: niversity of Glasgow & Greater Glasgow Health Board

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-02-20
• Study Completion: 2009-06-25
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 110

Inclusion Criteria

Inclusion criteria
1.Diagnosis of asthma: This will be established symptomatically by episodic wheezing, chest tightness and/or dyspnoea and objectively confirmed by
methacholine airway hyperresponsiveness < 8mg/ml or evidence of variable airflow obstruction with an increase in FEV1 of > 12% following nebulised salbutamol (2.5mg) or diurnal peak flow variability of > 20% in a week during the run-in period of the study. This is calculated using the morning peak flow readings over a week using the formula Min%/Max); GINA guidelines 2006.
2.Age range 18-60 years
3.Duration of asthma > 1 year and either on stable medication for 4 weeks or weaned from medication according to protocol.
4.Symptomatic; defined as an asthma control questionnaire score of 1 (range 0-6) prior to randomisation (using complete 7 question score) or
use of inhaled beta2-agonist on 3 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.
5.Smoking asthmatics will be defined as current cigarette smokers who have a > 5 pack year smoking history.
6.No other medication for their asthma other than a short-acting bronchodilator (step 1 British Asthma Guidelines).
7.Adjustment of asthma medication to BTS guidelines if required.
If subjects are stable and on long acting bronchodilators (LABA) and/or inhaled corticosteroids (up to 2000 mcg of beclometasone), an attempt will be made to carefully wean them off this medication over 4-6 weeks.

COPD: Pilot Sub Study
1. Age range 40-80 years
2. Diagnosis of COPD as defined by GOLD guidelines
Mild COPD: FEV1/FVC < 70%; FEV1 = 80% predicted;
Moderate COPD: FEV1/FVC < 70% and FEV1 50 - 79% predicted

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria
1.Ex-smokers or never smokers
2.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’ visit of patients to the GP; GP visit to patient at home; A & E hospital attendance; hospital admission]
3.Patients on statin therapy
4.Any known sensitivity or adverse reaction to statin, or previous evidence of myopathy or myositis plus creatine kinase and liver function tests > x2 upper limit of normal range. If elevated creatine kinase is possibly due to vigorous exercise, then it will be repeated after a week. If elevated, the patient will not be included in the study.
5.Patients who have a definite history of seasonal worsening of asthma will not be recruited during that season, eg. grass pollen season.
6.Patients who require medications known to interact with statins, such as azole antifungal agents, erythromycin, clarithromycin, cyclosporine, gemfibrozil, verapamil and amiodarone.
7.Patients who require other asthma medication such as leukotriene receptor antagonists or theophyllines.
8.Unable to understand or unwilling to sign the consent form.
9.Pregnancy, planned pregnancy in the next 6 months and lactation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Secondary Objective: The secondary end point will be to test the hypothesis that statins can reduce inflammation in smokers with chronic asthma.<br> To determine whether statins have a synergisitic effect when combined with inhaled corticosteroids.<br> ;Primary end point(s): Improvement in the morning peak expiratory flow rates (PEF) following statin treatment compared to placebo and statin+inhaled corticosteroid compared to statin+placebo.;Main Objective: The principal objective will be to determine if statins can improve asthma control in smokers with chronic asthma.