Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000162617
Ethics application status
Approved
Date submitted
1/08/2005
Date registered
16/08/2005
Date last updated
16/08/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised, prospective double-blind trial of long-term daily versus weekly azithromycin in cystic fibrosis
Scientific title
A randomised, prospective double-blind trial of long-term daily versus weekly azithromycin to determine the effect of dose on disease parameters in cystic fibrosis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 257 0
Condition category
Condition code
Human Genetics and Inherited Disorders 289 289 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 6-month randomised double-blind trial of 250mg daily versus 1200mg weekly azithromycin in cystic fibrosis
Intervention code [1] 84 0
Treatment: Drugs
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 336 0
Change in FEV1 % predicted.
Timepoint [1] 336 0
Measured at baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment)
Secondary outcome [1] 767 0
Antibiotic use
Timepoint [1] 767 0
All secondary outcomes will be measuredat baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment)
Secondary outcome [2] 768 0
Hospital days
Timepoint [2] 768 0
All secondary outcomes will be measuredat baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment).
Secondary outcome [3] 769 0
BMI,
Timepoint [3] 769 0
All secondary outcomes will be measuredat baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment).
Secondary outcome [4] 770 0
QOL
Timepoint [4] 770 0
All secondary outcomes will be measuredat baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment).
Secondary outcome [5] 771 0
CRP levels
Timepoint [5] 771 0
All secondary outcomes will be measuredat baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment).
Secondary outcome [6] 772 0
Cytokine response and bacteriology
Timepoint [6] 772 0
All secondary outcomes will be measuredat baseline, 1-month, 3-months, 6-months and 7-months (follow-up assessment).

Eligibility
Key inclusion criteria
Consenting children and adults (age >/6 years; weight >/ 25kg) with Clinically stable (at least 2 weeks since last acute IV/oral antibiotic therapy; FEV1 within 10% of average for last 6 months).
Minimum age
6 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to provide written informed consent. Patients with a known allergy to macrolides. Patients taking terfenadine (Teldane), zidovudine (AZT), digoxin (Lanoxin), cyclosporin (Neroal). Patients taking any macrolide antibiotics in the 8 weeks prior to enrolment. Atypical mycobacteria infection of clinical significance. Commencement of anti-inflammatory therapy or mucolytic therapy in the month prior to enrolment, or during the duration of the study. Patient or their partner pregnant, or planning to become pregnant in the next 6 months. Patients with known liver impairment: portal hypertension or proven liver cirrhosis.

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)
Central randomisation by Mater Pharmacy. Researchers, who were blinded to randomisation, were provided with a ⿿randomisation schedule⿝. Stratified for gender and lung function each participant was allocated the next pharmacy study number from the randomisation schedule. Each pharmacy involved in study was provided with a randomisation code, where by each study number was allocated to either arm A or arm B of the trial. All labelling of A or B was removed from packaging prior to dispensing so that all participants received identical medication packages, regardless of treatment arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Microsoft Excel was used by the Mater Pharmacy to generate the random allocation sequence. Randomisation is in blocks, stratified for gender and lung function.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
21/05/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
184
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 346 0
Charities/Societies/Foundations
Name [1] 346 0
Australian Cystic Fibrosis Research Trust
Country [1] 346 0
Australia
Funding source category [2] 347 0
Commercial sector/Industry
Name [2] 347 0
Pfizer Australia
Country [2] 347 0
Australia
Funding source category [3] 348 0
University
Name [3] 348 0
University of Queensland
Country [3] 348 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Joseph McCormack, University of Queensland, Department of Medicine, Mater Hospital, South Brisbane, 4101
Address
Country
Australia
Secondary sponsor category [1] 273 0
None
Name [1] 273 0
n/a
Address [1] 273 0
Country [1] 273 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1293 0
The University of Queensland
Ethics committee address [1] 1293 0
Ethics committee country [1] 1293 0
Australia
Date submitted for ethics approval [1] 1293 0
Approval date [1] 1293 0
Ethics approval number [1] 1293 0
Ethics committee name [2] 1294 0
Mater Adults and Children's Hospitals
Ethics committee address [2] 1294 0
Ethics committee country [2] 1294 0
Australia
Date submitted for ethics approval [2] 1294 0
Approval date [2] 1294 0
Ethics approval number [2] 1294 0
Ethics committee name [3] 1295 0
The Prince Charles Hospital
Ethics committee address [3] 1295 0
Ethics committee country [3] 1295 0
Australia
Date submitted for ethics approval [3] 1295 0
Approval date [3] 1295 0
Ethics approval number [3] 1295 0
Ethics committee name [4] 1296 0
The Royal Children's Hospital
Ethics committee address [4] 1296 0
Ethics committee country [4] 1296 0
Australia
Date submitted for ethics approval [4] 1296 0
Approval date [4] 1296 0
Ethics approval number [4] 1296 0
Ethics committee name [5] 1297 0
The Gold Coast Hospital
Ethics committee address [5] 1297 0
Ethics committee country [5] 1297 0
Australia
Date submitted for ethics approval [5] 1297 0
Approval date [5] 1297 0
Ethics approval number [5] 1297 0

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

Contacts
Principal investigator
Name 36102 0
Address 36102 0
Country 36102 0
Phone 36102 0
Fax 36102 0
Email 36102 0
Contact person for public queries
Name 9273 0
Sharon Senini
Address 9273 0
Department of Medicine
University of Queensland
Level 1 Administration Building
Mater Adult Hospital
South Brisbane QLD 4101
Country 9273 0
Australia
Phone 9273 0
+61 7 38408916
Fax 9273 0
+61 7 38401548
Email 9273 0
[email protected]
Contact person for scientific queries
Name 201 0
Assoc. Prof. Joseph McCormack
Address 201 0
Department of Medicine
University of Queensland
Level 1 Administration Building
Mater Adult Hospital
South Brisbane QLD 4101
Country 201 0
Australia
Phone 201 0
+61 7 38408518
Fax 201 0
+61 7 38401548
Email 201 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
No additional documents have been identified.