ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

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

Condition category

Condition code

Respiratory

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]

Treatment: Other

Comparator / control treatment

Placebo

Control group

Placebo

Outcomes

Primary outcome [1]

FEV1 measured by spirometry

Timepoint [1]

Recorded weekly at clinics.

Primary outcome [2]

The FEV1 to FVC ratio

Timepoint [2]

Recorded weekly at clinics.

Secondary outcome [1]

Asthma symptom score

Timepoint [1]

Secondary outcome [2]

Quality of life scale

Timepoint [2]

Measured weekly

Secondary outcome [3]

Bronchodilators and any other medication including inhaled steroid usage

Timepoint [3]

Measured daily

Secondary outcome [4]

In addition daily peak flow measurements and symptoms will be recorded in the diary.

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/07/2000

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

216

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Fauldings Pty Ltd

Address [1]

Country [1]

Primary sponsor type

Commercial sector/Industry

Name

Fauldings Pty Ltd

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

none

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Cross university HUman Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Professor Stephen Myers

Address

Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480

Country

Australia

Phone

+61 2 66203403

Fax

+61 2 66203307

smyers@scu.edu.au

Contact person for scientific queries

Name

Joan O'Connor

Address

Australian Centre for Complementary Medicine Education and Research (ACCMER)
PO Box 157
Lismore NSW 2480

Country

Australia

Phone

+61 2 66203649

Fax

+61 2 66203307

joconnor@scu.edu.au

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.

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