E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 | 10003553 |
E.1.2 | Term | Asthma |
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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 |
To determine whether macrolides improve bronchial hyperresponsiveness in patients with refractory asthma |
|
E.2.2 | Secondary objectives of the trial |
To provide information on the exacerbation rate in patients with refractory asthma To demonstrate the feasibility of treating patients with refractory asthma with a macrolide
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Non-smoking subjects aged 16 to 80 with refractory asthma, FEV1 >50% predicted and >1L and measurable airway responsiveness to methacholine challenge. Refractory asthma will be defined as an FEV1/FVC ratio less than 70% with evidence of poor asthma control in terms of regular night-time awakening (>2/week) or more than 4 puffs of relief medication/day (>twice/week) requiring repeated (2 or more per year) courses of oral corticosteroids despite treatment with high dose inhaled corticosteroids (≥1000mg beclomethasone or equivalent) and treatment with, or a previous unsuccessful trial of, a long-acting beta-agonist or leukotriene antagonist. |
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E.4 | Principal exclusion criteria |
Poor compliance with their usual asthma treatment as assessed by a review of primary care records, pregnancy, inadequate contraception or lactation, active smoking or smoking history in excess of 20 pack years, a clinical diagnosis of ABPA or significant bronchiectasis, other major co-morbidity including abnormal liver function tests or medication known to interact with azithromycin (aprepitant, atazanavir, atorvastatin, carbamazepine, ciclosporin, colchicine, disopyramide, efavirenz, eletriptan, eplerenone, itraconazone, ivabradine, methylprednisolone, midazolam, omeprazole, phenytoin, pimozide, repaglinide, ritabutin, rifamycins, ritonavir, sildenafil, simvastatin, sirolimus, tacrolimus, tadalafil, theophylline, tipranavir, tolterodine, verapamil, warfarin and zidovudine) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in bronchial reactivity (PD20 methacholine) |
|
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 | Yes |
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) | 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 | Yes |
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 | No |
E.8.5 | The trial involves multiple Member States | No |
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
|
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |