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Trial registered on ANZCTR


Trial ID
ACTRN12605000318684
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
6/09/2005
Date last updated
6/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Macrolide treatment of Non-Eosinophilic Asthma
Scientific title
A double blind randomised controlled study of the anti-inflammatory effects of clarithromycin 500mg twice daily for 8 weeks in adults with symptomatic Non-Eosinophilic Asthma
Universal Trial Number (UTN)
Trial acronym
NEAT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 406 0
Condition category
Condition code
Respiratory 477 477 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Clarithromycin 500mg twice daily for 8 weeks
Intervention code [1] 300 0
Treatment: Drugs
Comparator / control treatment
Placebo (calcium carbonate)
Control group
Placebo

Outcomes
Primary outcome [1] 546 0
IL-8 concentations in sputum supernatant
Timepoint [1] 546 0
Assessed at randomisation and at the end of the treatment.
Primary outcome [2] 547 0
MMP-9 concentations in sputum supernatant
Timepoint [2] 547 0
Assessed at randomisation and at the end of the treatment.
Secondary outcome [1] 1159 0
FEV1% predicted
Timepoint [1] 1159 0
Assessed at randomisation and at the end of treatment.
Secondary outcome [2] 1160 0
Short acting beta agonist use
Timepoint [2] 1160 0
Assessed at randomisation and at the end of treatment.
Secondary outcome [3] 1161 0
Asthma Control Score
Timepoint [3] 1161 0
Assessed at randomisation and at the end of treatment.
Secondary outcome [4] 1162 0
Quality of Life
Timepoint [4] 1162 0
Assessed at randomisation and at the end of treatment.

Eligibility
Key inclusion criteria
Symptomatic stable asthma, airway hyperresponsiveness and or bronchodilator response.
Minimum age
Not stated
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Hypersensitivity to Macrolides, Other Respiratory Disease, Taking antihistamine medication, Pregnancy, Breast Feeding, Oral Corticosteroid use in past month, Antibiotic use in past month.

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 identical capsules and non-identifying labelling
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocks. Random allocation was generated using web based software www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)

Funding & Sponsors
Funding source category [1] 540 0
Government body
Name [1] 540 0
NHMRC
Address [1] 540 0
Country [1] 540 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 437 0
None
Name [1] 437 0
None
Address [1] 437 0
Country [1] 437 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1537 0
Hunter New England Health Service
Ethics committee address [1] 1537 0
Ethics committee country [1] 1537 0
Australia
Date submitted for ethics approval [1] 1537 0
Approval date [1] 1537 0
Ethics approval number [1] 1537 0
Ethics committee name [2] 1538 0
University of Newcastle
Ethics committee address [2] 1538 0
Ethics committee country [2] 1538 0
Australia
Date submitted for ethics approval [2] 1538 0
Approval date [2] 1538 0
Ethics approval number [2] 1538 0

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

Contacts
Principal investigator
Name 35377 0
Address 35377 0
Country 35377 0
Phone 35377 0
Fax 35377 0
Email 35377 0
Contact person for public queries
Name 9489 0
Dr Jodie L Simpson
Address 9489 0
Respiratory and Sleep Medicine
Hunter Medical Research Institute
Level 3
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre
Newcastle NSW 2310
Country 9489 0
Australia
Phone 9489 0
+61 2 49214965
Fax 9489 0
+61 2 49855850
Email 9489 0
jodie.simpson@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 417 0
Professor Peter G Gibson
Address 417 0
Respiratory and Sleep Medicine
Hunter Medical Research Institute
Level 3
John Hunter Hospital
Locked Bag 1
Hunter Region Mail Centre
Newcastle NSW 2310
Country 417 0
Australia
Phone 417 0
+61 2 49855766
Fax 417 0
+61 2 49855850
Email 417 0
peter.gibson@hnehealth.nsw.gov.au