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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01475721




Registration number
NCT01475721
Ethics application status
Date submitted
17/11/2011
Date registered
21/11/2011
Date last updated
6/08/2018

Titles & IDs
Public title
SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.
Scientific title
SAS115359, a Safety and Efficacy Study of Inhaled Fluticasone Propionate/Salmeterol Combination Versus Inhaled Fluticasone Propionate in the Treatment of Adolescent and Adult Subjects With Asthma
Secondary ID [1] 0 0
115359
Universal Trial Number (UTN)
Trial acronym
AUSTRI
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ADVAIR 100/50mcg
Treatment: Drugs - ADVAIR 250/50mcg
Treatment: Drugs - ADVAIR 500/50mcg
Treatment: Drugs - FLOVENT 100mcg
Treatment: Drugs - FLOVENT 250mcg
Treatment: Drugs - FLOVENT 500mcg

Experimental: ADVAIR 100/50mcg - experimental drug

Experimental: ADVAIR 250/50mcg - experimental drug

Experimental: ADVAIR 500/50mcg - experimental drug

Active comparator: FLOVENT 100mcg - active comparator

Active comparator: FLOVENT 250mcg - active comparator

Active comparator: FLOVENT 500mcg - active comparator


Treatment: Drugs: ADVAIR 100/50mcg
fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months

Treatment: Drugs: ADVAIR 250/50mcg
fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months

Treatment: Drugs: ADVAIR 500/50mcg
fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months

Treatment: Drugs: FLOVENT 100mcg
fluticasone propionate (100) twice daily (AM and PM) for 6 months

Treatment: Drugs: FLOVENT 250mcg
fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months

Treatment: Drugs: FLOVENT 500mcg
fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing an Event in the Composite Safety Endpoint of Serious Asthma Outcomes ( Asthma-related Hospitalization, Asthma-related Endotracheal Intubation, or Asthma-related Death)
Timepoint [1] 0 0
From Day 1 up to 26 weeks
Primary outcome [2] 0 0
Number of Participants Experiencing at Least One Asthma Exacerbation
Timepoint [2] 0 0
From Day 1 up to 26 weeks
Secondary outcome [1] 0 0
Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death
Timepoint [1] 0 0
From Day 1 up to 26 weeks
Secondary outcome [2] 0 0
Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation
Timepoint [2] 0 0
From Day 1 up to 26 weeks
Secondary outcome [3] 0 0
Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours
Timepoint [3] 0 0
From Day 1 up to 26 weeks

Eligibility
Key inclusion criteria
* Provided consent to participate in the study
* Male or female, 12 years of age and older
* Clinical diagnosis of asthma for at least 1 year prior to the randomization
* Clinic PEF of greater than or equal to 50% of predicted normal value
* Subject must be appropriately using one of the treatments for asthma listed in the protocol
* Subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a DISKUS inhaler
* Subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization:
* requiring treatment with systemic corticosteroids
* an asthma-related hospitalization
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support
* Concurrent respiratory disease other than asthma
* Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
* Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
* Presence of a bacterial or viral respiratory infection that is not resolved at randomization
* An asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization
* More than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
* Subject must not meet unstable asthma severity criteria as listed in the protocol
* Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
* Pregnancy, breast-feeding or planned pregnancy during the study
* A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
23/06/2015
Sample size
Target
Accrual to date
Final
11751
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
GSK Investigational Site - Broadmeadow
Recruitment hospital [2] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [3] 0 0
GSK Investigational Site - Westmead
Recruitment hospital [4] 0 0
GSK Investigational Site - Auchenflower
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GSK Investigational Site - Redcliffe
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GSK Investigational Site - Woolloongabba
Recruitment hospital [7] 0 0
GSK Investigational Site - Bedford Park
Recruitment hospital [8] 0 0
GSK Investigational Site - Clayton
Recruitment hospital [9] 0 0
GSK Investigational Site - Subiaco
Recruitment hospital [10] 0 0
GSK Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2031 - Randwick
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2145 - Westmead
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4066 - Auchenflower
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4020 - Redcliffe
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4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5042 - Bedford Park
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
6008 - Subiaco
Recruitment postcode(s) [10] 0 0
3052 - Parkville
Recruitment outside Australia
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Stoke on Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Parexel
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess whether the risk of serious asthma-related events (asthma-related hospitalizations, endotracheal intubations, and deaths) in adolescents and adults (12 years of age and older) taking inhaled fluticasone propionate/salmeterol combination is the same as those taking inhaled fluticasone propionate alone.

ADVAIR™ and FLOVENT™ are trademarks of the GlaxoSmithKline Group of Companies.
Trial website
https://clinicaltrials.gov/study/NCT01475721
Trial related presentations / publications
Busse W, Stempel D, Aggarwal B, Boucot I, Forth R, Raphiou I, Rabe KF, Reddel HK. Insights from the AUSTRI study on reliever use before and after asthma exacerbations. J Allergy Clin Immunol Pract. 2022 Jul;10(7):1916-1918.e2. doi: 10.1016/j.jaip.2022.03.029. Epub 2022 Apr 9. No abstract available.
Stempel DA, Raphiou IH, Kral KM, Yeakey AM, Emmett AH, Prazma CM, Buaron KS, Pascoe SJ; AUSTRI Investigators. Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone. N Engl J Med. 2016 May 12;374(19):1822-30. doi: 10.1056/NEJMoa1511049. Epub 2016 Mar 6.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01475721