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Trial registered on ANZCTR


Registration number
ACTRN12605000465651
Ethics application status
Approved
Date submitted
14/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A 13 month, randomised, double-blind, parallel-group comparison of the efficacy of Seretide (fluticasone propionate/salmeterol combination Accuhaler) and Flixotide (fluticasone propionate Accuhaler) when down-titrating the inhaled corticosteroid dose in asthmatic adults who have previously received Seretide 500/50 ug twice daily for at least 4 weeks.
Scientific title
A 13 month, randomised, double-blind, parallel-group comparison of the efficacy of Seretide (fluticasone propionate/salmeterol combination Accuhaler) and Flixotide (fluticasone propionate Accuhaler) when down-titrating the inhaled corticosteroid dose in asthmatic adults who have previously received Seretide 500/50 ug twice daily for at least 4 weeks.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 584 0
Condition category
Condition code
Respiratory 656 656 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible subjects enter a run-in phase and receive open label Seretide Accuhaler 500/50 ug twice daily for 4 weeks. An Electronic Diary Card (EDC) is used twice daily to capture spirometry measurements (PEF & FEV1), asthma symptoms and medication use. Subjects who do not suffer an exacerbation and demonstrate satisfactory use of their EDC will be randomised to receive either flucticasone proprionate (FP) 500 ug twice daily alone or in combination with salmeterol (Seretide) for 8 weeks.

Four weeks after randomisation, subjects will return to the clinic (Visit 3) for assessment of their level of asthma control, using the Total Asthma Score (TAS).The TAS is based on asthma symptoms, frequency of Ventolin (salbutamol) use and electronic spirometric monitoring over 4 weeks preceeding a visit. Subjects will then enter the down titration phase of the study and visit the clinic every 8 weeks for 11 months (Visits 4-9). At each visit their eligibility for a step down to a lower dose of FP will be assessed using the TAS. Subjects will be eligible for a dose reduction if their TAS is stable or lower than at the previous visit. Subjects who complete week 52 will be considered to have completed the study.
Intervention code [1] 608 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 781 0
To demonstrate that Seretide allows greater down-titration of the dose of inhaled corticosteriod (ICS) without loss of asthma control compared to FP alone
Timepoint [1] 781 0
Assessed via the average daily FP dose (ug/day) from week 0 to completion/withdrawal including study and exacerbation medication.
Secondary outcome [1] 1581 0
Optimal asthma control and TAS
Timepoint [1] 1581 0
Secondary outcome [2] 1582 0
The number of asthma-free days
Timepoint [2] 1582 0
Secondary outcome [3] 1583 0
Average morning and evening PEF and FEV1
Timepoint [3] 1583 0
Secondary outcome [4] 1584 0
PEF variation (min%max)
Timepoint [4] 1584 0
Assessed at each visit.
Secondary outcome [5] 1585 0
ACQ and AQLQ scores.
Timepoint [5] 1585 0
Changes from baseline.
Secondary outcome [6] 1586 0
Dose reduction failure.
Timepoint [6] 1586 0
Secondary outcome [7] 1587 0
Markers of airway inflammation.
Timepoint [7] 1587 0

Eligibility
Key inclusion criteria
Clinical diagnosis of asthma according to the American Thoracic Society for at least 6 months prior to enrolment; prior treatment with Seretide, either by Accuhaler or by MDI (with or without spacer), at a dose of 500/50 ug bd or 250/25 ug 2 inhalations bd, for a minimum of 4 weeks prior to enrolment; willing and able to comply with thetherapy and EDC requirements.Inclusion criteria for randomisation and entry into the down-titration period:Demonstrated ability to comply with the EDC requirements during run-in, plus evidence of adequate unsupervised spirometric technique; no moderate or severe exacerbation(s) in the past 4 weeks.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current smokers,subjects with a smoking history of >10 pack years or subjects who have given up smoking within 4 weeks prior to Visit 1; use of oral/parenteral or depot corticosteroids within 3 months prior to Visit 1; an acute asthma exacerbation requiring hospital admission within 3 months prior to Visit 1; a respiratory tract infection within the four weeks prior to Visit 1; other significant chronic respiratory disease; evidence of extrathoracic airway obstruction demonstrated by a plateau on the inspiratory flow volume loop at Visit 1; pregnant or lactating women.

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)
Concealed randomisation with sequential allocation of treatment numbers and allocation of pre-filled numbered packs.Treatment packs will be provided at each Dose Level for each Treatment Number. The treatment dose at each visit will be prescribed by dose level thus maintaining the blinding of the randomisation assignment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Treatment and pack schedules are computer generated random permuted blocks using SAS version 8.
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
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] 725 0
Self funded/Unfunded
Name [1] 725 0
Address [1] 725 0
Country [1] 725 0
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline Australia Pty Ltd
Address
Country
United Kingdom
Secondary sponsor category [1] 601 0
None
Name [1] 601 0
Nil
Address [1] 601 0
Country [1] 601 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1922 0
Royal Prince Alfred Hospital
Ethics committee address [1] 1922 0
Ethics committee country [1] 1922 0
Australia
Date submitted for ethics approval [1] 1922 0
Approval date [1] 1922 0
Ethics approval number [1] 1922 0
Ethics committee name [2] 1923 0
John Hunter Hospital
Ethics committee address [2] 1923 0
Ethics committee country [2] 1923 0
Australia
Date submitted for ethics approval [2] 1923 0
Approval date [2] 1923 0
Ethics approval number [2] 1923 0
Ethics committee name [3] 1924 0
Concord Repatriation General Hospital
Ethics committee address [3] 1924 0
Ethics committee country [3] 1924 0
Australia
Date submitted for ethics approval [3] 1924 0
Approval date [3] 1924 0
Ethics approval number [3] 1924 0

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

Contacts
Principal investigator
Name 36240 0
Address 36240 0
Country 36240 0
Phone 36240 0
Fax 36240 0
Email 36240 0
Contact person for public queries
Name 9797 0
Dr Helen Reddel
Address 9797 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9797 0
Australia
Phone 9797 0
+61 2 95157026
Fax 9797 0
+61 2 95506115
Email 9797 0
hkr@med.usyd.edu.au
Contact person for scientific queries
Name 725 0
Dr Helen Reddel
Address 725 0
Woolcock Institute of Medical Research
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 725 0
Australia
Phone 725 0
+61 2 95157026
Fax 725 0
+61 2 95506115
Email 725 0
hkr@med.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary