Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000286549
Ethics application status
Approved
Date submitted
29/06/2006
Date registered
7/07/2006
Date last updated
22/04/2020
Date data sharing statement initially provided
22/01/2020
Date results provided
22/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Lycopene supplementation in stable asthma
Scientific title
A placebo-controlled, double-blind, randomised control trial using lycopene-rich supplements to reduce neutrophlic airway inflammation in asthma
Secondary ID [1] 286683 0
Nil known
Universal Trial Number (UTN)
Trial acronym
DAX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 1261 0
Condition category
Condition code
Respiratory 1347 1347 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following a 2 week washout on a low antioxidant diet, subjects receive oral lycopene supplements (45mg/day) for 12 weeks. A comparison group consume a diet high in antioxidants for the duration of the study.
Intervention code [1] 1182 0
Treatment: Other
Comparator / control treatment
Placebo for 12 weeks, A comparison group consume a diet high in antioxidants for the duration of the study.
Control group
Placebo

Outcomes
Primary outcome [1] 1837 0
Induced sputum neutrophil count
Timepoint [1] 1837 0
Measured at baseline, week 2,6,10 and 14.
Secondary outcome [1] 3219 0
Asthma Control Score
Timepoint [1] 3219 0
Measured at baseline, week 2,6,10 and 14.
Secondary outcome [2] 3220 0
Airway hyperresponsiveness
Timepoint [2] 3220 0
Measured at baseline, week 2,6,10 and 14.

Eligibility
Key inclusion criteria
Stable asthma, Non-smokers
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other respiratory disease, Vitamin or mineral use.

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 concealed by blinded list held by independent statistician
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/07/2006
Actual
11/07/2006
Date of last participant enrolment
Anticipated
Actual
5/02/2009
Date of last data collection
Anticipated
Actual
6/05/2009
Sample size
Target
192
Accrual to date
Final
139
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 1474 0
Government body
Name [1] 1474 0
National Health and Medical Research Council
Country [1] 1474 0
Australia
Primary sponsor type
Government body
Name
Hunter New England Health Service
Address
Lookout Rd, New Lambton NSW 2305
Country
Australia
Secondary sponsor category [1] 1301 0
None
Name [1] 1301 0
None
Address [1] 1301 0
Country [1] 1301 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2856 0
John Hunter Hospital (Hunter New England Health Service)
Ethics committee address [1] 2856 0
Ethics committee country [1] 2856 0
Australia
Date submitted for ethics approval [1] 2856 0
Approval date [1] 2856 0
22/06/2006
Ethics approval number [1] 2856 0
05/03/09/3.09

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

Contacts
Principal investigator
Name 36243 0
Prof Lisa Wood
Address 36243 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 36243 0
Australia
Phone 36243 0
+61240420147
Fax 36243 0
Email 36243 0
[email protected]
Contact person for public queries
Name 10371 0
Lisa Wood
Address 10371 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 10371 0
Australia
Phone 10371 0
+61240420147
Fax 10371 0
+61 2 40420046
Email 10371 0
[email protected]
Contact person for scientific queries
Name 1299 0
Lisa Wood
Address 1299 0
Centre for Asthma and Respiratory Diseases
Level 2, West Wing, HMRI Building
Kookaburra Crt
New Lambton Heights, NSW, 2305
AUSTRALIA
Country 1299 0
Australia
Phone 1299 0
+61 2 4042 0147
Fax 1299 0
+61 2 4042 0046
Email 1299 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.