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Trial registered on ANZCTR


Registration number
ACTRN12606000508572
Ethics application status
Approved
Date submitted
21/02/2006
Date registered
7/12/2006
Date last updated
24/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Does combination therapy increase adherence with inhaled corticosteroids and improve clinical outcomes in asthma?
Scientific title
Does therapy with an inhaled combination of fluticasone and salmeterol improve clinical outcomes and compliance with taking asthma medication in patients with asthma?
Secondary ID [1] 280249 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 1486 0
Condition category
Condition code
Respiratory 1581 1581 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised, single-blind, parallel group, single centre study. Patients will receive fluticasone propionate (FP) and salmeterol, either as combination inhaler therapy or as separate inhalers. Participants will be advised to take their metered dose inhalers (2 puffs) twice daily, resulting in a daily dose of 500µg FP and 100µg salmeterol with both regimens. Adherence will be assessed by covert adherence monitors incorporated into all inhaler devices used. Treatment will be twice daily for 24 weeks.
Intervention code [1] 908 0
Treatment: Drugs
Comparator / control treatment
Patients will receive fluticasone propionate (FP) and salmeterol as separate inhalers
Control group
Active

Outcomes
Primary outcome [1] 2184 0
1. Adherence, defined as the proportion of medication (fluticasone propionate and salmeterol either in combination or separatetly) taken as directed
Timepoint [1] 2184 0
In the final six week period of the study.
Primary outcome [2] 2185 0
2. Overuse of medication, defined as the mean number of extra doses taken per day
Timepoint [2] 2185 0
In the final six week period of the study.
Secondary outcome [1] 3812 0
1. Adherence: defined as (i) the proportion of medication taken as directed in the first, second and third six week periods of the study and (ii) the proportion of patients who took >50%, >80% or >90% of their mediation as prescribed.
Timepoint [1] 3812 0
6 weeks, 12 weeks and 18 weeks
Secondary outcome [2] 3813 0
2. Overuse: defined as (i) percentage of days in which an extra dose was taken in each six week period, (ii) maximum number of puffs taken in any one day in each six week period and (iii) number of times 'dose dumping' occurred in each six week period.
Timepoint [2] 3813 0
6 weeks, 12 weeks and 18 weeks

Eligibility
Key inclusion criteria
Doctor diagnosis of asthma, Currently prescribed inhaled corticosteroids (ICS), Steady dose of ICS for at least one month, No exacerbation in the previous month requiring a GP or hospital visit, No exacerbation in the run-in period.
Minimum age
16 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of clinically significant disease which may affect the outcome of the study, Currently prescribed combination therapy (inhaled corticosteroid and long acting beta agonist in combined inhaler), No known sensitivity to beta-agonists, salmeterol or any of its ingredients.

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)
Central randomisation by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The patients only are blinded.
Phase
Type of endpoint(s)
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 outside Australia
Country [1] 286 0
New Zealand
State/province [1] 286 0

Funding & Sponsors
Funding source category [1] 1727 0
Commercial sector/Industry
Name [1] 1727 0
GlaxoSmithKline
Address [1] 1727 0
GlaxoSmithKline UK Ltd.
Stockley Park West,
Uxbridge,
Middlesex,
UB11 1BT
Country [1] 1727 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
GlaxoSmithKline UK Ltd.
Stockley Park West,
Uxbridge,
Middlesex,
UB11 1BT
Country
United Kingdom
Secondary sponsor category [1] 1522 0
None
Name [1] 1522 0
None
Address [1] 1522 0
Country [1] 1522 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Asthma is a common condition which can cause significant disruptions to everyday life. There are many different drugs to treat asthma including inhaled corticosteroids (ICS) and long-acting beta-agonists (LABAs). A key problem in treating asthma is that patients sometimes do not take their medication as prescribed. This is commonly seen with ICS as they are not perceived to provide immediate relief. Combination ICS/LABA inhalers have been developed, which could be expected to improve a patient’s ability to adhere to their prescription as fewer doses and inhalers are needed, compared with separate inhaler medication. The purpose of this study is to assess whether a combined ICS/LABA inhaler (Seretide) has any effect on adherence to prescribed dose compared with single dose inhalers containing Flixotide (fluticasone propionate) and Serevent (salmeterol). The study will involve a treatment period of 24 weeks and patients will attend the clinic at 6 weekly intervals. Patients will be randomly allocated to receive treatment by either combination or separate inhalers.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36149 0
Address 36149 0
Country 36149 0
Phone 36149 0
Fax 36149 0
Email 36149 0
Contact person for public queries
Name 10097 0
Dr Kyle Perrin
Address 10097 0
Medical Research Institute of New Zealand
Level 3, 99 The Terrace
Wellington
Country 10097 0
New Zealand
Phone 10097 0
+64 (0)4 4729199
Fax 10097 0
+64 (0)4 4729224
Email 10097 0
Kyle.Perrin@ccdhb.org.nz
Contact person for scientific queries
Name 1025 0
Dr Kyle Perrin
Address 1025 0
Medical Research Institute of New Zealand
Level 3, 99 The Terrace
Wellington
Country 1025 0
New Zealand
Phone 1025 0
+64 (0)4 4729199
Fax 1025 0
+64 (0)4 4729224
Email 1025 0
Kyle.Perrin@ccdhb.org.nz

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