A Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Oral Azithromycin (500 Mg OD) as a Supplement to Standard Care for Adult Patients with Acute Exacerbations of Asthma - AZithromycin Against pLacebo in Exacerbations of Asthma (AZALEA)
- Conditions
- Asthma (exacerbations of)
- Registration Number
- EUCTR2011-001093-26-GB
- Lead Sponsor
- Imperial College, London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 199
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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the clinical efficacy of oral Azithromycin treatment as a supplement to standard care for adult patients with acute exacerbations of asthma.;Primary end point(s): Diary card summary symptom score, with symptoms including wheezing, breathlessness and coughing assessed at 10 days after randomisation.;Secondary Objective: 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
- Secondary Outcome Measures
Name Time Method