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Trial record 15 of 43 for:    "Bronchial Disease" | "Azithromycin"

AZithromycin Against pLacebo in Exacerbations of Asthma (AZALEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01444469
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : July 23, 2014
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
Acute attacks (exacerbations) of asthma are common and cause a great deal of suffering in asthmatic patients. Current treatments for asthma attacks are not completely effective and new and better treatments are needed. Viruses often cause asthma attacks and bacterial lung infections have also been associated with asthma attacks. However, the role for bacteria is uncertain. Current asthma guidelines for doctors treating asthma exacerbations do not recommend the routine use of antibiotics. The investigators would like to investigate whether or not azithromycin, which is a safe and well tolerated antibiotic (an antibacterial) that has been used for many years in the treatment of respiratory disease, might be of benefit in asthma attacks. As there is some evidence that azithromycin has anti-viral properties this may add to its benefits (antibiotics don't usually affect viruses). By looking at the effect of azithromycin on asthma attacks this will help us to show whether or not azithromycin should be recommended during an acute asthma attack in addition to the usual care that is provided to these patients as it may help them recover quicker from the exacerbation. The investigators will also be able to look at why azithromycin may be effective - if it is having an anti-bacterial and/or anti-viral effect.

Condition or disease Intervention/treatment Phase
Asthma Drug: Zithromax Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Azithromycin (Zithromax)
500 mg of azithromycin (2×250mg capsules)
Drug: Zithromax
250mg * 2 capsules once daily for three days
Other Name: Azithromycin

Placebo Comparator: Placebo
Drug: Placebo
Lactose powder

Primary Outcome Measures :
  1. Diary card summary symptom score [ Time Frame: 10 days after randomisation ]
    Symptoms include wheezing, breathlessness and coughing assessed at 10 days after randomisation.

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 5 & 10 days post randomisation ]
    • Health status assessed by acute asthma QolQ (Juniper)
    • Health status assessed by Mini Asthma QolQ (Juniper)

  2. Time to 50% reduction in symptom score [ Time Frame: From Visit 1 (day 1) to Visit 4 (day 42) ]
  3. Pulmonary Function tests [ Time Frame: 5 & 10 days post randomisation ]
    Pulmonary function tests include: FEV1, FVC, FEV1/FVC ratio, PEF, FEF25-75% and FEF50%

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 48 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:

  • Patients with known prolongation of the QT interval, a history of torsades de pointes, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure, patients on drugs known to prolong the QT interval and patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, aminodarone, sotalol) antiarrhythmic agents.
  • Smokers aged 56-65 with a >20 pack year history, or aged >65 with >5 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 > 20mg 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01444469

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United Kingdom
Barnsley Hospital NHS Foundation
Barnsley, England, United Kingdom, S75 2EP
Countess of Chester Hospital NHS Foundation Trust
Liverpool, England, United Kingdom, CH2 1UL
Surrey & Sussex Healthcare NHS Trust
Surrey, England, United Kingdom, RH1 5RH
Heart of England NHS Foundation Trust
Birmingham, United Kingdom, B9 5SS
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom, FY3 8NR
University of Glasgow
Glasgow, United Kingdom, G12 0YN
University Hospitals of Leicester NHS Foundation Trust
Leicester, United Kingdom, LE39QP
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1PG
University Hospital of South Manchester Foundation Trust
Manchester, United Kingdom, M23 9QZ
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom, NE7 7DN
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom, PO6 3LY
University Hospital of North Tees
Stockton-on-Tees, United Kingdom, TS19 8PE
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield, United Kingdom, NG17 4JL
Sponsors and Collaborators
Imperial College London
National Institute for Health Research, United Kingdom
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Study Chair: Sebastian L Johnston, MBBS, PhD, FRCP Imperial College London

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Imperial College London Identifier: NCT01444469     History of Changes
Other Study ID Numbers: 2011-001093-26
10/60/27 ( Other Grant/Funding Number: NIHR EME )
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: November 2013

Keywords provided by Imperial College London:
Asthma exacerbations
Respiratory disease
Viral infection
Macrolide/ketolide antibiotics
Mycoplasma pneumoniae (M. pneumoniae)
Chlamydophila pneumoniae (C. pneumoniae)

Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Bacterial Agents
Anti-Infective Agents