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Trial registered on ANZCTR
Registration number
ACTRN12608000460303
Ethics application status
Approved
Date submitted
14/08/2008
Date registered
16/09/2008
Date last updated
9/01/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Bronchiectasis and low dose erythromycin
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Scientific title
The effect of long-term, low-dose erythromycin on pulmonary exacerbations of bronchiectasis - a randomised controlled trial
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Secondary ID [1]
279658
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nil
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Universal Trial Number (UTN)
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Trial acronym
BLESS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-Cystic Fibrosis Bronchiectasis
3562
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Condition category
Condition code
Respiratory
3718
3718
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0
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Erythromycin (as ethylsuccinate salt) 400 mgs orally twice daily for 48 weeks
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Intervention code [1]
3276
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Treatment: Drugs
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Comparator / control treatment
Placebo, matching tablet, oral lactose/ magnesium stearate orally twice daily for 48 weeks
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Mean rate of protocol-defined pulmonary exacerbations per patient per year, measured by intention to treat
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Assessment method [1]
4622
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Timepoint [1]
4622
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Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
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Primary outcome [2]
4623
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Mean rate of protocol-defined pulmonary exacerbations per patient per year, measured per protocol (ie subjects who do not complete 48 weeks of therapy for whatever reason will be excluded from this analysis)
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Assessment method [2]
4623
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Timepoint [2]
4623
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Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
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Secondary outcome [1]
7799
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Rates of all exacerbations (ie including both protocol-defined exacerbations and exacerbations for which the subject recieves antibiotic therapy, but which does not meet the specific criteria defined)
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Assessment method [1]
7799
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Timepoint [1]
7799
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Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
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Secondary outcome [2]
7800
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Total days of antibiotic use (intravenous and oral)
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Assessment method [2]
7800
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Timepoint [2]
7800
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Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
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Secondary outcome [3]
7801
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Total courses of antibiotics (intravenous and oral)
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Assessment method [3]
7801
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Timepoint [3]
7801
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Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
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Secondary outcome [4]
7802
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Total days of oral antibiotic use
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Assessment method [4]
7802
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Timepoint [4]
7802
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Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
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Secondary outcome [5]
7803
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Total courses of oral antibiotics
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Assessment method [5]
7803
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Timepoint [5]
7803
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Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
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Secondary outcome [6]
7804
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Quality of life (St George's Respiratory Questionnaire)
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Assessment method [6]
7804
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Timepoint [6]
7804
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Measured at Baseline and weeks 4,8,16,24,32,40,48,52
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Secondary outcome [7]
7805
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24 hour sputum volume
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Assessment method [7]
7805
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Timepoint [7]
7805
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Measured at Baseline and weeks 4,8,16,24,32,40,48,52
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Secondary outcome [8]
7806
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Inflammatory markers in sputum, assessed by a variety of methods including specific Enzyme-Linked Immunosorbent Assays (ELISA's), microbead multiplex assays, radioimmunoassays, neutrophil elastase-specific substrate activity by absorbance
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Assessment method [8]
7806
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Timepoint [8]
7806
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Baseline and weeks 4, 24, 48, 52
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Secondary outcome [9]
7807
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Mucins in sputum assessed using both quantitative ELISA's and mucin specific antibodies
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Assessment method [9]
7807
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Timepoint [9]
7807
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Baseline and weeks 4,24,48,52
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Secondary outcome [10]
7808
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Bacterial species characterisation by polymerase chain reaction (PCR) in sputum, by Terminal Restriction Length Polymorphism (T-RFLP) profiling of the phylogenetically informative 16S rRNA gene as amplified from nucleic acids extracted from samples
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Assessment method [10]
7808
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Timepoint [10]
7808
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Baseline and weeks 4,8,16,24,32,40,48,52
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Secondary outcome [11]
7809
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Rheology of sputum, using a controlled stress rheometer operating in dynamic oscillatory mode
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Assessment method [11]
7809
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Timepoint [11]
7809
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Baseline and weeks 4,24,48,52
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Secondary outcome [12]
7810
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Proportion of macrolide-resistant streptococci isolated from oropharyngeal swabs
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Assessment method [12]
7810
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Timepoint [12]
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Basline and weeks 4,48
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Secondary outcome [13]
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Quality of life (Leicester cough questionnaire)
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Assessment method [13]
7811
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Timepoint [13]
7811
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Baseline and weeks 4,8,16,24,32,40,48,52
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Secondary outcome [14]
7812
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Bronchiectasis symptoms (Bronchiectasis symptoms questionnaire)
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Assessment method [14]
7812
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Timepoint [14]
7812
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Baseline and weeks 4,8,16,24,32,40,48,52
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Secondary outcome [15]
7813
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Lung function - forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) measured by spirometer
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Assessment method [15]
7813
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Timepoint [15]
7813
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Baseline and weeks 4,8,16,24,32,40,48,52
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Secondary outcome [16]
7814
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identification/ analaysis of cell marker expression by immunohistochemistry in endobronchial biopsies
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Assessment method [16]
7814
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Timepoint [16]
7814
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Baseline and weeks 4 and 48
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Secondary outcome [17]
7815
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Inflammatory gene expression in endobronchial biopsies
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Assessment method [17]
7815
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Timepoint [17]
7815
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Baseline and weeks 4 and 48
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Secondary outcome [18]
7816
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Airway wall remodelling in endobronchial biopsies
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Assessment method [18]
7816
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Timepoint [18]
7816
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Baseline and weeks 4,48
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Secondary outcome [19]
7817
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Inflammatory markers in bronchoalveolar lavage fluid, including neutrophil elastase activity, TNF-alpha, IL-8, MPO, TCC, SLPI, LTB4
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Assessment method [19]
7817
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Timepoint [19]
7817
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Basline and weeks 4, 48
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Secondary outcome [20]
7818
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Total and differential inflammatory cell counts in sputum and bronchoalveolar lavage fluid
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Assessment method [20]
7818
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Timepoint [20]
7818
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Baseline, weeks 4 and 48
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Eligibility
Key inclusion criteria
1. Bronchiectasis on high-resolution computed tomographic scans of the lungs
2. At least 2 pulmonary exacerbations in the preceding 12 months requiring antibiotic therapy
3. Chronic productive cough with daily sputum production
4. Clinically stable and no alteration to therapies in the 4 weeks preceding screening
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Minimum age
20
Years
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Maximum age
85
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Cystic Fibrosis, tuberrculosis, non-tuberculous mycobacterial infection, focal endobronchial obstructing lesion
2. Smoking within the preceding 6 months
3. Maintenance oral antibiotic therapy
4. Any condition likely to result in a shortened life span within the 12 months of the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed. Subjects will be identified from the hospital clinic and advertising. Subjects meeting the inclusion criteria and consenting to enrolment will be randomly allocated to treatment or placebo by the pharmacy department after notification by the trial coordinator. Treatment allocation will be performed and study drug supplied by pharmacy staff not otherwise involved in the study.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated blocked randomisation sequences, stratified for the presence or absence of Pseudomonas aeruginosa colonisation at study entry will be generated and held by the pharmacy department.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
24/10/2008
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
118
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
3741
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Address [1]
3741
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Country [1]
3741
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Primary sponsor type
Individual
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Name
Dr David Serisier
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Address
Dept of Respiratory Medicine
Mater Adult Hospital, Lvl 9
Raymond Tce
South Brisbane, Qld. 4101
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Country
Australia
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Secondary sponsor category [1]
3355
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None
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Name [1]
3355
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Address [1]
3355
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Country [1]
3355
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
5793
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Mater Health Services HREC
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Ethics committee address [1]
5793
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Mater health Services
Aubigny Place
Raymond Tce
South Brisbane, Qld. 4101
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Ethics committee country [1]
5793
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Australia
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Date submitted for ethics approval [1]
5793
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17/07/2008
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Approval date [1]
5793
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26/08/2008
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Ethics approval number [1]
5793
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Mater Research Ethics Committee Approval 1244A
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Summary
Brief summary
Macrolide antibiotics have beneficial effects in chronic infections of the lung, although apparently not due to antibacterial effects. We suspect that erythromycin in a low dose will alter inflammation in the lungs of subjects with bronchiectasis, and reduce the frequency of lung infections.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
28848
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Email
28848
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Contact person for public queries
Name
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Megan Martin
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Address
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Dept of Respiratory Medicine
Mater Adult Hospital, Lvl 9
Raymond Tce
South Brisbane, Qld. 4101
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Country
12005
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Australia
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Phone
12005
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0731632128
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Fax
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0731638519
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr David Serisier
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Address
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Dept of Respiratory Medicine
Mater Adult Hospital, Lvl 9
Raymond Tce
South Brisbane, Qld. 4101
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Country
2933
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Australia
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Phone
2933
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0731632128
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Fax
2933
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0731638519
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Email
2933
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[email protected]
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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
Source
Title
Year of Publication
DOI
Dimensions AI
Impact of Long-Term Erythromycin Therapy on the Oropharyngeal Microbiome and Resistance Gene Reservoir in Non-Cystic Fibrosis Bronchiectasis
2018
https://doi.org/10.1128/msphere.00103-18
Dimensions AI
Abstracts\' Service
2022
https://doi.org/10.5005/ijcdas-57-2-137
N.B. These documents automatically identified may not have been verified by the study sponsor.
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