Trial Review

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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
Scientific title
The effect of long-term, low-dose erythromycin on pulmonary exacerbations of bronchiectasis - a randomised controlled trial
Secondary ID [1] 279658 0
nil
Universal Trial Number (UTN)
Trial acronym
BLESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Cystic Fibrosis Bronchiectasis 3562 0
Condition category
Condition code
Respiratory 3718 3718 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Erythromycin (as ethylsuccinate salt) 400 mgs orally twice daily for 48 weeks
Intervention code [1] 3276 0
Treatment: Drugs
Comparator / control treatment
Placebo, matching tablet, oral lactose/ magnesium stearate orally twice daily for 48 weeks
Control group
Placebo

Outcomes
Primary outcome [1] 4622 0
Mean rate of protocol-defined pulmonary exacerbations per patient per year, measured by intention to treat
Timepoint [1] 4622 0
Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
Primary outcome [2] 4623 0
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)
Timepoint [2] 4623 0
Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
Secondary outcome [1] 7799 0
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)
Timepoint [1] 7799 0
Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
Secondary outcome [2] 7800 0
Total days of antibiotic use (intravenous and oral)
Timepoint [2] 7800 0
Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
Secondary outcome [3] 7801 0
Total courses of antibiotics (intravenous and oral)
Timepoint [3] 7801 0
Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
Secondary outcome [4] 7802 0
Total days of oral antibiotic use
Timepoint [4] 7802 0
Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
Secondary outcome [5] 7803 0
Total courses of oral antibiotics
Timepoint [5] 7803 0
Measured at all visits (monthly), but outcome measure is evaluated at 48 weeks after randomisation
Secondary outcome [6] 7804 0
Quality of life (St George's Respiratory Questionnaire)
Timepoint [6] 7804 0
Measured at Baseline and weeks 4,8,16,24,32,40,48,52
Secondary outcome [7] 7805 0
24 hour sputum volume
Timepoint [7] 7805 0
Measured at Baseline and weeks 4,8,16,24,32,40,48,52
Secondary outcome [8] 7806 0
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
Timepoint [8] 7806 0
Baseline and weeks 4, 24, 48, 52
Secondary outcome [9] 7807 0
Mucins in sputum assessed using both quantitative ELISA's and mucin specific antibodies
Timepoint [9] 7807 0
Baseline and weeks 4,24,48,52
Secondary outcome [10] 7808 0
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
Timepoint [10] 7808 0
Baseline and weeks 4,8,16,24,32,40,48,52
Secondary outcome [11] 7809 0
Rheology of sputum, using a controlled stress rheometer operating in dynamic oscillatory mode
Timepoint [11] 7809 0
Baseline and weeks 4,24,48,52
Secondary outcome [12] 7810 0
Proportion of macrolide-resistant streptococci isolated from oropharyngeal swabs
Timepoint [12] 7810 0
Basline and weeks 4,48
Secondary outcome [13] 7811 0
Quality of life (Leicester cough questionnaire)
Timepoint [13] 7811 0
Baseline and weeks 4,8,16,24,32,40,48,52
Secondary outcome [14] 7812 0
Bronchiectasis symptoms (Bronchiectasis symptoms questionnaire)
Timepoint [14] 7812 0
Baseline and weeks 4,8,16,24,32,40,48,52
Secondary outcome [15] 7813 0
Lung function - forced expiratory volume in the first second (FEV1) and forced vital capacity (FVC) measured by spirometer
Timepoint [15] 7813 0
Baseline and weeks 4,8,16,24,32,40,48,52
Secondary outcome [16] 7814 0
identification/ analaysis of cell marker expression by immunohistochemistry in endobronchial biopsies
Timepoint [16] 7814 0
Baseline and weeks 4 and 48
Secondary outcome [17] 7815 0
Inflammatory gene expression in endobronchial biopsies
Timepoint [17] 7815 0
Baseline and weeks 4 and 48
Secondary outcome [18] 7816 0
Airway wall remodelling in endobronchial biopsies
Timepoint [18] 7816 0
Baseline and weeks 4,48
Secondary outcome [19] 7817 0
Inflammatory markers in bronchoalveolar lavage fluid, including neutrophil elastase activity, TNF-alpha, IL-8, MPO, TCC, SLPI, LTB4
Timepoint [19] 7817 0
Basline and weeks 4, 48
Secondary outcome [20] 7818 0
Total and differential inflammatory cell counts in sputum and bronchoalveolar lavage fluid
Timepoint [20] 7818 0
Baseline, weeks 4 and 48

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
Minimum age
20 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
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
24/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
118
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3741 0
Self funded/Unfunded
Name [1] 3741 0
Country [1] 3741 0
Primary sponsor type
Individual
Name
Dr David Serisier
Address
Dept of Respiratory Medicine
Mater Adult Hospital, Lvl 9
Raymond Tce
South Brisbane, Qld. 4101
Country
Australia
Secondary sponsor category [1] 3355 0
None
Name [1] 3355 0
Address [1] 3355 0
Country [1] 3355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5793 0
Mater Health Services HREC
Ethics committee address [1] 5793 0
Ethics committee country [1] 5793 0
Australia
Date submitted for ethics approval [1] 5793 0
17/07/2008
Approval date [1] 5793 0
26/08/2008
Ethics approval number [1] 5793 0
Mater Research Ethics Committee Approval 1244A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28848 0
Address 28848 0
Country 28848 0
Phone 28848 0
Fax 28848 0
Email 28848 0
Contact person for public queries
Name 12005 0
Megan Martin
Address 12005 0
Dept of Respiratory Medicine
Mater Adult Hospital, Lvl 9
Raymond Tce
South Brisbane, Qld. 4101
Country 12005 0
Australia
Phone 12005 0
0731632128
Fax 12005 0
0731638519
Email 12005 0
megan.martin@mater.org.au
Contact person for scientific queries
Name 2933 0
Dr David Serisier
Address 2933 0
Dept of Respiratory Medicine
Mater Adult Hospital, Lvl 9
Raymond Tce
South Brisbane, Qld. 4101
Country 2933 0
Australia
Phone 2933 0
0731632128
Fax 2933 0
0731638519
Email 2933 0
david.serisier@mater.org.au

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 AIImpact of Long-Term Erythromycin Therapy on the Oropharyngeal Microbiome and Resistance Gene Reservoir in Non-Cystic Fibrosis Bronchiectasis2018https://doi.org/10.1128/msphere.00103-18
Dimensions AIAbstracts\' Service2022https://doi.org/10.5005/ijcdas-57-2-137
N.B. These documents automatically identified may not have been verified by the study sponsor.