E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Asthma (exacerbations of) |
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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 |
To evaluate the clinical efficacy of oral Azithromycin treatment as a supplement to standard care for adult patients with acute exacerbations of asthma. |
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E.2.2 | Secondary objectives of the trial |
Our mechanistic/exploratory objectives are to: * determine the frequencies of detection of viral, atypical bacterial and standard bacterial infections in acute exacerbations of asthma. * evaluate mechanisms of activity of Azithromycin during exacerbations of asthma by assessment of clinical improvement relative to initial o C. pneumoniae and/or M. pneumoniae status o standard bacteriologic status o virologic status o sputum inflammatory cell/mediator status |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients meeting all of the following criteria will be considered for admission to the study: • Adults, either sex, ages 18-55 years or age 56 to 65 with < 20 pack year smoking history or >65 with <5 pack year smoking history • Patients with a documented history of asthma for >6 consecutive months, and • Patients presenting within 24 hours (of initial presentation to medical care) with an acute deterioration in asthma control (increased wheeze, dyspnea and/or cough and/or reduced PEF) and requiring a course of oral steroids • Patients with a PEF or FEV1 less than 80% of predicted normal or patient’s best at presentation, at recruitment or in the time elapsed between presentation and recruitment • Patients must be able to complete diaries and quality of life questionnaires. • Patients must sign and date an informed consent prior to any study procedures. |
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E.4 | Principal exclusion criteria |
Patients presenting with any of the following will not be included in the study: • Smokers aged 56-65 with a > or equal to 20 pack year history • Patients requiring immediate placement in ICU • Patients who used oral or systemic antibiotics within 28 days prior to enrolment • Patients with known impaired hepatic function (ALT/AST > 2 ULN) • Patients with significant lung disease (including COPD) other than asthma • Patients with ≥ 10mg oral corticosteroid maintenance therapy • Patients requiring other antibiotic therapy • Patients who are receiving other medications or who have other disease conditions or infections that could interfere with the evaluation of drug efficacy or safety • Women who are breast-feeding or are pregnant, as demonstrated by a urine pregnancy test carried out before exposure to study medication or the start of any study procedure that could pose a risk to the foetus • Patients with suspected or known hypersensitivity to, or suspected serious adverse reaction to Azithromycin or any of the macrolide or ketolide class of antibiotics, erythromycin or to any excipients thereof • Patients who have received treatment with any other investigational drug within 1 month prior to study entry, or have such treatment planned for the study period during treatment and follow up phase • Patients with a concomitant condition (including clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease) making implementation of the protocol or interpretation of the study results difficult • Patients with mental conditions rendering them unable to understand the nature, scope, and possible consequences of the study. • Patients unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits. • No subject will be allowed to enrol in this study more than once. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Diary card summary symptom score, with symptoms including wheezing, breathlessness and coughing assessed at 10 days after randomisation. |
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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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |