AZithromycin Against pLacebo in Exacerbations of Asthma (AZALEA)

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 age >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.

Exclusion Criteria:

Patients presenting with any of the following will not be included in the study:

• Smokers aged 56-65 with a >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.