E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 of this randomised controlled trial is to test the hypothesis that statins improve asthma control of patients with chronic asthma. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to assess changes in airway hyperreactivity and inflammation in asthmatics treated with statins compared to placebo. Secondary endpoints include changes in asthma symptom scores, exacerbation rates, spirometry, airway responsiveness to methacholine, sputum cell counts, exhaled nitric oxide, immunological tests in blood and asthma quality of life questionnaire. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. 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% during the run-in period of the study 2.Age range 18–70 years 3. Duration of asthma > 1 year and on stable medication for four weeks 4.Receiving regular inhaled steroid treatment (British Asthma Management Guidelines: step 2 only) 5. 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 week before randomisation or FEV1 reversibility >12% or diurnal peak flow variability of >20% during the run-in period of the study 6. Written informed consent |
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E.4 | Principal exclusion criteria |
1. Inability to demonstrate correct use of peak flow meter after instruction 2. Current smokers or ex-smokers of < 1 year or ex-smokers who have smoked > 5 pack years. 3. Asthma exacerbation 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] 4. Patients in whom cardiovascular risk requires statin therapy 5. Any known sensitivity to statin, or previous evidence of myopathy or myositis plus creatinine kinase and liver function tests <x2 upper limit of normal range, pregnancy/lactation. 6. Non-atopic asthma 7. Patients who show specific IgE sensitivity or are skin test positive to grass pollen allergen will not be recruited from mid May to end of July (grass allergen season in UK) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement in the morning peak flow rates (PEF) following statin treatment compared to placebo. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |