E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Asthma (smokers),COPD. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The principal objective will be to determine if statins can improve asthma control in smokers with chronic asthma. |
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E.2.2 | Secondary objectives of the trial |
The secondary end point will be to test the hypothesis that statins can reduce inflammation in smokers with chronic asthma. To determine whether statins have a synergisitic effect when combined with inhaled corticosteroids. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pilot Study of 24 patients Full Title: : Effect of statins in lung function and airway inflammation in patients with chronic obstructive pulmonary disease (COPD):a randomised controlled double-blind parallel group study. Date:14th March 2007 Protocol:AR003 Version: 2 Related objectives:To assess whether statins can improve lung function and reduce inflammation in patients with COPD |
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E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |