NCT01444469

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Sep 2011

Typical duration for phase_4 asthma

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 22, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 30, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

2.8 years

First QC Date

September 22, 2011

Last Update Submit

January 8, 2024

Conditions

Asthma

Keywords

Asthma exacerbationsRespiratory diseaseViral infectionMacrolide/ketolide antibioticsMycoplasma pneumoniae (M. pneumoniae)Chlamydophila pneumoniae (C. pneumoniae)

Outcome Measures

Primary Outcomes (1)

  • Diary card summary symptom score

    Symptoms include wheezing, breathlessness and coughing assessed at 10 days after randomisation.

    10 days after randomisation

Secondary Outcomes (3)

  • Quality of life assessed by acute asthma QolQ (Juniper)

    5 & 10 days post randomisation

  • Time to 50% reduction in symptom score

    From Visit 1 (day 1) to Visit 4 (day 42)

  • Pulmonary Function tests

    5 & 10 days post randomisation

Study Arms (2)

Azithromycin (Zithromax)

EXPERIMENTAL

500 mg of azithromycin (2Ă—250mg capsules)

Drug: Zithromax

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

ZithromaxDRUG

250mg \* 2 capsules once daily for three days

Also known as: Azithromycin
Azithromycin (Zithromax)
PlaceboDRUG

Lactose powder

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Barnsley Hospital NHS Foundation

Barnsley, England, S75 2EP, United Kingdom

Location

Countess of Chester Hospital NHS Foundation Trust

Liverpool, England, CH2 1UL, United Kingdom

Location

Surrey & Sussex Healthcare NHS Trust

Redhill, England, RH1 5RH, United Kingdom

Location

Heart of England NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

Location

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, FY3 8NR, United Kingdom

Location

University of Glasgow

Glasgow, G12 0YN, United Kingdom

Location

University Hospitals of Leicester NHS Foundation Trust

Leicester, LE39QP, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W2 1PG, United Kingdom

Location

University Hospital of South Manchester Foundation Trust

Manchester, M23 9QZ, United Kingdom

Location

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE7 7DN, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Portsmouth Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Location

University Hospital of North Tees

Stockton-on-Tees, TS19 8PE, United Kingdom

Location

Sherwood Forest Hospitals NHS Foundation Trust

Sutton in Ashfield, NG17 4JL, United Kingdom

Location

Related Publications (1)

  • Johnston SL, Szigeti M, Cross M, Brightling C, Chaudhuri R, Harrison T, Mansur A, Robison L, Sattar Z, Jackson D, Mallia P, Wong E, Corrigan C, Higgins B, Ind P, Singh D, Thomson NC, Ashby D, Chauhan A; AZALEA Trial Team. Azithromycin for Acute Exacerbations of Asthma : The AZALEA Randomized Clinical Trial. JAMA Intern Med. 2016 Nov 1;176(11):1630-1637. doi: 10.1001/jamainternmed.2016.5664.

    PMID: 27653939DERIVED

MeSH Terms

Conditions

AsthmaRespiration DisordersVirus Diseases

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesInfections

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Sebastian L Johnston, MBBS, PhD, FRCP

    Imperial College London

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2011

First Posted

September 30, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 10, 2024

Record last verified: 2024-01

Locations

GB(14)