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Trial registered on ANZCTR


Trial ID
ACTRN12605000234617
Ethics application status
Approved
Date submitted
24/08/2005
Date registered
26/08/2005
Date last updated
21/09/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy study of Faulding's sea cucumber extracts in mild to moderate adult asthma
Scientific title
A randomised research study to determine the efficacy of Faulding's sea cucumber extract alone and the efficacy of the combination of Faulding's sea cucmber extract with Boswellia serrata versus placebo for the treatment of mild to moderate adult asthma to determine changes in FEV1 measured by spirometry.
Universal Trial Number (UTN)
Trial acronym
none
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild to moderate asthma 320 0
Condition category
Condition code
Respiratory 365 365 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
These studies will facilitate 3 sets of comparisons:
* Faulding's sea cucumber extract alone versus placebo
* the combination of Faulding's sea cucmber extract with Boswellia serrata versus placebo
* the combination of Faulding's sea cucumber extract with Boswellia serrata versus sea cucumber extract alone.
Intervention code [1] 243 0
Treatment: Other
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 425 0
FEV1 measured by spirometry
Timepoint [1] 425 0
Recorded weekly at clinics.
Primary outcome [2] 426 0
The FEV1 to FVC ratio
Timepoint [2] 426 0
Recorded weekly at clinics.
Secondary outcome [1] 916 0
Asthma symptom score
Timepoint [1] 916 0
Secondary outcome [2] 917 0
Quality of life scale
Timepoint [2] 917 0
Measured weekly
Secondary outcome [3] 918 0
Bronchodilators and any other medication including inhaled steroid usage
Timepoint [3] 918 0
Measured daily
Secondary outcome [4] 919 0
In addition daily peak flow measurements and symptoms will be recorded in the diary.
Timepoint [4] 919 0

Eligibility
Key inclusion criteria
Greater than or equal to 10% improvement in FEV1 after administration of 200mcg inhaled salbutamol sulphate (=2 puffs) NOT less than 6 hours after previous use of inhaled salbutamol sulphate; non-smoking; FEV1 greater than 60% of the predicted value for age and sex; subjects who have given their informed written consent; subjects who have at least one asthma symptom (cough or wheeze) per week; subjects of childbearing age who agree to continue using contraceptive measures for the duration of the study.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe asthma as defined by the National Asthma Campaign (1998) -refer to attached handbook; any other clinically significant respiratory disease; a history of acute upper or lower respiratory tract infection within 4 weeks of starting the study; a history of oral or inhaled steroid use or leukotriene receptor antagonists within 3 months of starting the study; female subjects who are pregnant or lactating; subjects with contra-indications to the study medications; any clinically significant abnormality or disease associated with significant respiratory morbidity; subjects with any condition that, in the opinion of the investigator could be detrimental to the health of the subjects or might interfere with the evaluation of the study objective.

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)
Subjects were randomly allocated to one of the two treatments or placebo. Study subjects and investigators did not know the treatment assignment. Use of the double-blind design prevented ascertainment bias. The placebo was identical in size, shape, colour and weight to the active counterparts. Both preparations were odourless.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects were assigned on a first come, first recruited basis. The tablets were supplied in numbered containers by the sponsor.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other
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)

Funding & Sponsors
Funding source category [1] 424 0
Commercial sector/Industry
Name [1] 424 0
Fauldings Pty Ltd
Address [1] 424 0
Country [1] 424 0
Primary sponsor type
Commercial sector/Industry
Name
Fauldings Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 343 0
None
Name [1] 343 0
none
Address [1] 343 0
Country [1] 343 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1396 0
Southern Cross university HUman Research Ethics Committee
Ethics committee address [1] 1396 0
Ethics committee country [1] 1396 0
Australia
Date submitted for ethics approval [1] 1396 0
Approval date [1] 1396 0
Ethics approval number [1] 1396 0

Summary
Brief summary
The study is a multi centre double blind, randomised, placebo controlled parallel design. There will be three arms - placebo, sea cucumber extract and sea cucumber extract plus Boswellia serrata. Three comparisons can be undertaken from this design - 1. sea cucumber extract alone versus placebo 2. the combination of sea cucumber extract with Boswellia serrata extract versus placebo 3. sea cucumber extract alone versus the combination of sea cucumber extract with Boswellia serrata extract.A sample size calculation, setting a and b at 0.05 and 0.8 respectively, was undertaken based on the variability of FEV1 in men (mean 3.5, SD 1.5) and setting d at 15% (0.7L) required 60 subjects in each arm. The study will aim to recruit 72 subjects in each arm. Total 216 subjects. Allowing for up to 15% drop-out should secure a minimum of 60 subjects in each arm.Randomisation and BlindingSubjects will be randomly allocated to one of the two treatments or placebo. Study subjects and investigators will not know the treatment assignment. Use of the double blind design will prevent ascertainment bias. The placebo will be identical in size, shape, colour and weight to the active counterparts. Both preparations will be odourless.Study SitesThe study will be carried out in four centres Lismore, Ballina, Casino and Brisbane. In Lismore the study will be based at the Teaching Clinic of the School of Natural and Complementary Medicine. The study will be based at local council facilities in Ballina and Casino. In Brisbane the study will be conducted at Greenslopes Private Hospital using the University of Queensland Department of Surgery clinic facilities. In NSW Lismore is the largest population centre and it is therefore considered that Lismore is likely to be the largest contributing centre to the study. Lismore will have four clinics per week on Monday, Tuesday, Wednesday and Thursday, Ballina two clinics on Monday and Wednesday, Casino two clinics on Tuesday and Thursday. Clinics will be held between 4pm and 8pm. In Brisbane, clinics will be held on Monday and Thursday between 4pm and 9pm.Safety MonitoringA full blood count, liver function test; and urea, creatinine and electrolytes will be taken at the start of the study, the mid-point of the study (week 8) and at the end of the study. At each follow up visit subjects will be carefully assessed for adverse events ie any new complaint or symptom that emerges during treatment with the study medication or any new complaint or pre-existing symptom that increases in frequency and/or intensity during treatment with the study medication.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36319 0
Address 36319 0
Country 36319 0
Phone 36319 0
Fax 36319 0
Email 36319 0
Contact person for public queries
Name 9432 0
Professor Stephen Myers
Address 9432 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 9432 0
Australia
Phone 9432 0
+61 2 66203403
Fax 9432 0
+61 2 66203307
Email 9432 0
smyers@scu.edu.au
Contact person for scientific queries
Name 360 0
Joan O'Connor
Address 360 0
Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480
Country 360 0
Australia
Phone 360 0
+61 2 66203649
Fax 360 0
+61 2 66203307
Email 360 0
joconnor@scu.edu.au