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Trial Details
indicate updates made to monitored data item(s) since trial registration. These data item(s) are monitored to ensure they comply with the WHO / journal editors standards.
Request Number:
082430
ACTR Number:
ACTRN12607000641493
Trial Status:
Registered
Date Submitted:
21/11/2007
Date Registered:
17/12/2007
Page 1
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.
Update:
Reason:
ANZCTR registration 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.
Update:
Reason:
Secondary ID:
UTN:
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Reason:
Trial acronym:
EMBRACE
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Page 2
Health condition(s) or problem(s) studied:
Bronchiectasis
Condition category:
Condition code:
Respiratory
Other respiratory disorders / diseases
Page 3
Description of intervention(s) / exposure:
One capsule of Azithromycin 500mg or placebo taken on Monday, Wednesday and Friday morning for 26 weeks.
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Reason:
Intervention code 1:
Prevention
Intervention code 2:
Treatment: drugs
Comparator / control treatment:
Placebo - calcium lactate in a matching colour capsule.
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Reason:
Control group:
Placebo
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Reason:
Page 4
Primary outcome 1:
Exacerbation frequency
Timepoint:
at baseline through to 26 weeks after randomisation
Primary outcome 2:
Airway function (change in Forced Expiratory Volume in 1 second (FEV1)) as measured by the Microlab Spirometer.
Timepoint:
at baseline and at 4, 13 and 26 weeks after intervention commencement
Primary outcome 3:
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:
at baseline, 13 weeks and 26 weeks after intervention commencement
Secondary outcome 1:
Time to first exacerbation, severity and duration
Timepoint:
at baseline through to 52 weeks after randomisation
Secondary outcome 2:
Change in markers of airway inflammation (sputum cell count)
Timepoint:
at baseline, 26 weeks and 52 weeks after intervention commencement
Page 5
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.
Update:
Reason:
Minimum Age:
18
Years
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Reason:
Maximum Age:
80
Years
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Reason:
Gender:
Both males and females
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Reason:
Healthy volunteers?
No
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Reason:
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.
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Reason:
Page 6
Study type:
Interventional
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Reason:
Purpose of the study:
Prevention
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Allocation to intervention:
Randomised controlled trial
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Reason:
Describe the 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.
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Reason:
Describe the 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.
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Reason:
Masking / blinding:
Blinded (masking used)
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Reason:
Who is/are masked/blinded:
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Reason:
Assignment:
Parallel
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Reason:
Other design features (specify):
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Reason:
Type of endpoint(s):
Efficacy
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Reason:
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Page 7
Phase
Not Applicable
Update:
Reason:
Anticipated or actual date of first participant enrolement:
8/01/2008
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Reason:
Target sample size:
140
Update:
Reason:
Recruitment status:
Not yet recruiting
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Reason:
Page 8
Funding source:
Government funding body e.g. Australian Research Council
Name:
NZ Health Research Council
Address:
PO Box 5541 Wellesley Street Auckland
Country:
New Zealand
Primary sponsor:
Charities/Societies/Foundations
Update:
Reason:
Name:
Centre for Clinical Research and Effective Practice (CCRep)
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Reason:
Address:
Private Bag 93311 Otahuhu Auckland
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Reason:
Country:
New Zealand
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Reason:
Secondary sponsor:
Hospital
Name:
Middlemore Hospital
Address:
Private Bag 93311 Otahuhu Auckland
Country:
New Zealand
Other collaborator:
Page 9
Has the study received approval from at least one ethics committee?
Yes
Update:
Reason:
Ethics Committee name:
Northern X Ethics Committee
Address:
Private Bag 92-522 Wellesley Street Auckland
Country:
New Zealand
Date of approval:
20/11/2008
HREC Number:
NTX/07/00/099
Countries of recruitment:
Outside Australia
New Zealand
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.
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Reason:
Trial website:
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Presentations / publication list:
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Page 10
Contact person for public queries
Name:
Cecilia Tong
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Reason:
Address:
CCRep
Private Bag 93311
Otahuhu, Auckland
Update:
Reason:
Country:
New Zealand
Update:
Reason:
Tel:
+64 9 276 0044 extn 2117
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Reason:
Fax:
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Reason:
Email:
CTong@middlemore.co.nz
Update:
Reason:
Contact person for scientific queries
Name:
Dr Conroy Wong
Update:
Reason:
Address:
Middlemore Hospital
Private Bag 93311
Otahuhu, Auckland
Update:
Reason:
Country:
New Zealand
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Reason:
Tel:
+64 9 276 0044 extn 8803
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Reason:
Fax:
Update:
Reason:
Email:
CAWong@middlemore.co.nz
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Reason:
Contact person responsible for updating information
Name:
Ruth Withers
Update:
Reason:
Address:
CCRep
Private Bag 93311
Otahuhu, Auckland
Update:
Reason:
Country:
New Zealand
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Reason:
Tel:
+64 9 276 0044 extn 2967
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Reason:
Fax:
+64 9 250 3828
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Reason:
Email:
ruth.withers@middlemore.co.nz
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Reason:
