Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000641493
Ethics application status
Approved
Date submitted
21/11/2007
Date registered
17/12/2007
Date last updated
12/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Prophylactic Azithromycin for Bronchiectasis, a randomised controlled trial to assess whether azithromycin reduces exacerbation frequency, improves health-related quality of life and increases lung function.
Scientific title
Prophylactic Azithromycin for Bronchiectasis, a randomised controlled trial to assess whether azithromycin reduces exacerbation frequency, improves health-related quality of life and increases lung function.
Secondary ID [1] 273219 0
New secondary ID. CCRep 100079
Universal Trial Number (UTN)
Trial acronym
EMBRACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 2567 0
Condition category
Condition code
Respiratory 2672 2672 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One capsule of Azithromycin 500mg or placebo taken on Monday, Wednesday and Friday morning for 26 weeks.
Intervention code [1] 2299 0
Prevention
Intervention code [2] 2300 0
Treatment: Drugs
Comparator / control treatment
Placebo - calcium lactate in a matching colour capsule.
Control group
Placebo

Outcomes
Primary outcome [1] 3577 0
Exacerbation frequency
Timepoint [1] 3577 0
at baseline through to 26 weeks after randomisation
Primary outcome [2] 3578 0
Airway function (change in Forced Expiratory Volume in 1 second (FEV1)) as measured by the Microlab Spirometer.
Timepoint [2] 3578 0
at baseline and at 4, 13 and 26 weeks after intervention commencement
Primary outcome [3] 3579 0
Health related quality of life (change in St. George Respiratory Questionnaire (SGRQ) - a print out questionnaire using a total score of 26 will be used to measure this)
Timepoint [3] 3579 0
at baseline, 13 weeks and 26 weeks after intervention commencement
Secondary outcome [1] 5993 0
Time to first exacerbation, severity and duration
Timepoint [1] 5993 0
at baseline through to 52 weeks after randomisation
Secondary outcome [2] 5994 0
Change in markers of airway inflammation (sputum cell count)
Timepoint [2] 5994 0
at baseline, 26 weeks and 52 weeks after intervention commencement

Eligibility
Key inclusion criteria
1. Participants must have a diagnosis of bronchiectasis based on a high resolution Computer Tomography (CT) scan
2. Patient must be clinically stable during the baseline period
3. Patient must have at least one exacerbation in the last 12 months requiring treatment with antibiotics.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient with significant diseases other than bronchiectasis
2. Patient with cystic fibrosis
3. Patient with hypogammaglobulinaemia
4. Patients with primary dyskinesia
5. Patients with allergic brochopulmonary aspergillosis
6. Patients with non-tuberculous mycobacterial infection within 2 years.
7. Patients with a malignancyrequiring treatment in the last 5 years (patients with basal cell carcinoma are allowed)
8. Patients with active tuberculosis.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patient will be provided with the approved version of Patient information sheet (by local Ethics Committee) and a written consent to be obtained prior to any study procedure commencement. Patients will go through the screening tests as per protocol and then randomised after a run in period of 4 to 6 weeks when eligibility is confirmed. Randomisation will be sequential using the Drug kit numbers allocated to each individual centre. Allocation has been concealed through the allocation of numbered medication packs.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified by centres(3 locations) with an equal allocation of patients within centres to each group using a random permuted block. Computed-generated randomisation numbers will generate a drug kit code that is assigned as patient identification numbers at each sites.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/01/2008
Actual
24/01/2008
Date of last participant enrolment
Anticipated
Actual
30/10/2009
Date of last data collection
Anticipated
Actual
4/04/2011
Sample size
Target
140
Accrual to date
Final
141
Recruitment outside Australia
Country [1] 693 0
New Zealand
State/province [1] 693 0
Auckland and Hamilton

Funding & Sponsors
Funding source category [1] 2813 0
Government body
Name [1] 2813 0
NZ Health Research Council
Country [1] 2813 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Centre for Clinical Research and Effective Practice (CCRep)
Address
Private Bag 93311
Otahuhu
Auckland
Country
New Zealand
Secondary sponsor category [1] 2540 0
Hospital
Name [1] 2540 0
Middlemore Hospital
Address [1] 2540 0
Private Bag 93311
Otahuhu
Auckland
Country [1] 2540 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4738 0
Northern X Ethics Committee
Ethics committee address [1] 4738 0
Private Bag 92-522
Wellesley Street
Auckland
Ethics committee country [1] 4738 0
New Zealand
Date submitted for ethics approval [1] 4738 0
Approval date [1] 4738 0
20/11/2008
Ethics approval number [1] 4738 0
NTX/07/00/099

Summary
Brief summary
Bronchiectasis is a neglected health problem in New Zealand, particularly amongst Maori and Pacific peoples. It is a debilitating disease characterised by repeated respiratory infections. Azithromycin is a unique antibiotic with anti-inflammatory properties that has been shown to be effective as prophylaxis in cystic fibrosis. The aim of this study is to assess the effect of long term azithromycin in adult patients with non-cystic fibrosis bronchiectasis. It will be the first randomised, controlled trial in this important patient group and will provide data on clinically relevant outcome measures. The benefits to patients are expected to include improved quality of life, prevention or delay in decline of lung function and reduced acute healthcare utilisation and costs. Importantly, these benefits will also have a substantial impact on the health of Maori and Pacific peoples. We have a rare and unparalleled opportunity to undertake this study because of the high prevalence of bronchiectasis in NZ.
Trial website
Trial related presentations / publications
Wong C, Jayaram L, Karalus N, et al. Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis (EMBRACE): a randomised, double-blind, placebo-controlled trial. Lancet 2012;380:660-7.

Wong C, Jayaram L, Karalus N, Milne D, Tong C. Azithromycin in non-cystic-fibrosis bronchiectasis - Authors' reply. Lancet 2013;381:27.
Public notes

Contacts
Principal investigator
Name 28199 0
Dr Conroy Wong
Address 28199 0
Middlemore Hospital
100 Hospital Rd
Auckland 2025
Country 28199 0
New Zealand
Phone 28199 0
+64 9 2760000
Fax 28199 0
Email 28199 0
[email protected]
Contact person for public queries
Name 11356 0
Mrs Cecilia Tong
Address 11356 0
CCRep
Private Bag 93311
Otahuhu, Auckland
Country 11356 0
New Zealand
Phone 11356 0
+64 9 276 0044 extn 2117
Fax 11356 0
Email 11356 0
[email protected]
Contact person for scientific queries
Name 2284 0
Dr Dr Conroy Wong
Address 2284 0
Middlemore Hospital
Private Bag 93311
Otahuhu, Auckland
Country 2284 0
New Zealand
Phone 2284 0
+64 9 276 0044 extn 8803
Fax 2284 0
Email 2284 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIVitamin D-Cathelicidin Axis: at the Crossroads between Protective Immunity and Pathological Inflammation during Infection2020https://doi.org/10.4110/in.2020.20.e12
N.B. These documents automatically identified may not have been verified by the study sponsor.