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Trial registered on ANZCTR


Registration number
ACTRN12609000259246
Ethics application status
Approved
Date submitted
29/01/2009
Date registered
13/05/2009
Date last updated
11/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Azithromycin in older people with airway disease
Scientific title
A double-blind randomised controlled study of the anti-inflammatory effects of azithromycin 250mg daily for 12 weeks in adults with symptomatic neutrophilic airway disease
Secondary ID [1] 280777 0
MAZDA study
Universal Trial Number (UTN)
Trial acronym
MAZDA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 4249 0
Chronic obstructive pulmonary disease 4250 0
Condition category
Condition code
Respiratory 4470 4470 0 0
Chronic obstructive pulmonary disease
Respiratory 4471 4471 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Azithromycin 250mg daily for 12 weeks, by oral administration.
Intervention code [1] 3971 0
Treatment: Drugs
Comparator / control treatment
Placebo (lactose) 250mg daily for 12 weeks, by oral administration.
Control group
Placebo

Outcomes
Primary outcome [1] 5351 0
Interleukin-8 (IL-8) concentrations in sputum supernatant, detected via the use of laboratory Enzyme Linked Immunosorbent Assay (ELISA) kits.
Timepoint [1] 5351 0
Assessed at randomisation and at the end of treatment.
Secondary outcome [1] 8989 0
Sputum bacterial load, which will be assessed by a Pathology service through counting and identifying bacterial colonies in sputum samples.
Timepoint [1] 8989 0
Assessed at randomisation and at the end of treatment.
Secondary outcome [2] 8990 0
Neutrophil concentrations in sputum, which will be established through a differential cell count of muco-cellular clumps in sputum samples.
Timepoint [2] 8990 0
Assessed at randomisation and at the end of treatment.
Secondary outcome [3] 8991 0
Neutrophil elastase levels in sputum, which will be established through the use of a commercially available neutrophil elastase immunocapture activity assay kit.
Timepoint [3] 8991 0
Assessed at randomisation and at the end of treatment.
Secondary outcome [4] 8992 0
Forced expiratory volume in 1 second (FEV1) as a percentage of participants' predicted FEV1 (FEV1 %pred), measured through the use of spirometry.
Timepoint [4] 8992 0
Assessed at randomisation and at the end of treatment.
Secondary outcome [5] 8993 0
Short acting beta agonist use, assessed by participant self-report of average short acting beta agonist use per day and week.
Timepoint [5] 8993 0
Assessed at randomisation and at the end of treatment.
Secondary outcome [6] 8994 0
Quality of life, assessed by administration of the Juniper Quality of Life Questionnaire.
Timepoint [6] 8994 0
Assessed at randomisation and at the end of treatment.

Eligibility
Key inclusion criteria
Symptomatic stable asthma or Chronic Obstructive Pulmonary Disease (COPD), increased sputum neutrophils.
Minimum age
55 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hypersensitivity to macrolides, other respiratory disease, taking macrolide, tetracycline, antibiotic or oral corticosteroid in past month, taking antacid treatment, taking medication that prolongs the heart's corrected QT interval (QTc), current smoking, pregnancy, impaired liver function.

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)
Randomised by pharmacy using random number list, concealed from investigators by manufacturing identical active and placebo tablets and labelling in a non-identifying manner.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1406 0
2305

Funding & Sponsors
Funding source category [1] 4428 0
Government body
Name [1] 4428 0
National Health and Medical Research Council
Address [1] 4428 0
GPO Box 1421 Canberra City ACT 2601
Country [1] 4428 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Area Health Service
Address
Locked Bag 1, Hunter Region Mail Centre, Newcastle NSW 2310
Country
Australia
Secondary sponsor category [1] 3988 0
None
Name [1] 3988 0
Address [1] 3988 0
Country [1] 3988 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6477 0
Hunter New England Research Ethics Unit
Ethics committee address [1] 6477 0
Hunter New England Area Health Service
Locked Bag 1, Hunter Region Mail Centre, Newcastle NSW 2310
Ethics committee country [1] 6477 0
Australia
Date submitted for ethics approval [1] 6477 0
Approval date [1] 6477 0
19/12/2006
Ethics approval number [1] 6477 0
06/12/13/3.08

Summary
Brief summary
The primary purpose of the study is to further the identification of effective treatment options for people with obstructive airway diseases, such as asthma and chronic obstructive pulmonary disease, and neutrophilic inflammation. The study will investigate the anti-inflammatory effect of a macrolide antibiotic, azithromycin, on airway inflammation, symptoms, quality of life and lung function. It is hypothesised that azithromycin therapy will reduce bacteria in the sputum and inflammatory cells of participants with neutrophilic airway disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29230 0
Dr Jodie L Simpson
Address 29230 0
HMRI Level 2 West Wing
Lot 1 Kookaburra Circuit
New Lambton
NSW 2305
Country 29230 0
Australia
Phone 29230 0
+61240420148
Fax 29230 0
+61240420046
Email 29230 0
jodie.simpson@newcastle.edu.au
Contact person for public queries
Name 12477 0
Dr Jodie Simpson
Address 12477 0
Respiratory and Sleep Medicine, Hunter Medical Research Institute
Level 2 West Wing
Locked bag 1
Hunter Region Mail Centre
Newcastle NSW 2310
Country 12477 0
Australia
Phone 12477 0
+61240420148
Fax 12477 0
+61240420046
Email 12477 0
jodie.simpson@newcastle.edu.au
Contact person for scientific queries
Name 3405 0
Prof Professor Peter Gibson
Address 3405 0
Respiratory and Sleep Medicine, Hunter Medical Research Institute
Level 2 West Wing
Locked bag 1
Hunter Region Mail Centre
Newcastle NSW 2310
Country 3405 0
Australia
Phone 3405 0
+61 2 4985 5766
Fax 3405 0
+61 2 4985 5850
Email 3405 0
peter.gibson@hnehealth.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary