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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

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
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GSK Investigational Site - Westmead
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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
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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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Poland
State/province [202] 0 0
Sopot
Country [203] 0 0
Poland
State/province [203] 0 0
Szczecin
Country [204] 0 0
Poland
State/province [204] 0 0
Warszawa
Country [205] 0 0
Poland
State/province [205] 0 0
Wodzislaw Slaski
Country [206] 0 0
Poland
State/province [206] 0 0
Wolomin
Country [207] 0 0
Poland
State/province [207] 0 0
Wroclaw
Country [208] 0 0
Poland
State/province [208] 0 0
Zabrze
Country [209] 0 0
Poland
State/province [209] 0 0
Zgierz
Country [210] 0 0
Romania
State/province [210] 0 0
Brasov
Country [211] 0 0
Romania
State/province [211] 0 0
Cluj-Napoca
Country [212] 0 0
Romania
State/province [212] 0 0
Sibiu
Country [213] 0 0
Russian Federation
State/province [213] 0 0
Chelyabinsk
Country [214] 0 0
Russian Federation
State/province [214] 0 0
Kemerovo
Country [215] 0 0
Russian Federation
State/province [215] 0 0
Kirov
Country [216] 0 0
Russian Federation
State/province [216] 0 0
Krasnodar
Country [217] 0 0
Russian Federation
State/province [217] 0 0
Krasnoyarsk
Country [218] 0 0
Russian Federation
State/province [218] 0 0
Moscow
Country [219] 0 0
Russian Federation
State/province [219] 0 0
Novgorod
Country [220] 0 0
Russian Federation
State/province [220] 0 0
Novosibirsk
Country [221] 0 0
Russian Federation
State/province [221] 0 0
Orenburg
Country [222] 0 0
Russian Federation
State/province [222] 0 0
Pyatigorsk
Country [223] 0 0
Russian Federation
State/province [223] 0 0
Rostov-on-Don
Country [224] 0 0
Russian Federation
State/province [224] 0 0
Ryazan
Country [225] 0 0
Russian Federation
State/province [225] 0 0
Saint Petersburg
Country [226] 0 0
Russian Federation
State/province [226] 0 0
Saint-Petersburg
Country [227] 0 0
Russian Federation
State/province [227] 0 0
Saratov
Country [228] 0 0
Russian Federation
State/province [228] 0 0
St. Petersburg
Country [229] 0 0
Russian Federation
State/province [229] 0 0
Tomsk
Country [230] 0 0
Russian Federation
State/province [230] 0 0
Voronezh
Country [231] 0 0
Russian Federation
State/province [231] 0 0
Yaroslavl
Country [232] 0 0
Serbia
State/province [232] 0 0
Belgrade
Country [233] 0 0
Slovakia
State/province [233] 0 0
Kosice
Country [234] 0 0
Slovakia
State/province [234] 0 0
Kralovsky Chlmec
Country [235] 0 0
Slovakia
State/province [235] 0 0
Levice
Country [236] 0 0
Slovakia
State/province [236] 0 0
Martin
Country [237] 0 0
Slovakia
State/province [237] 0 0
Sturovo
Country [238] 0 0
Slovakia
State/province [238] 0 0
Trnava
Country [239] 0 0
South Africa
State/province [239] 0 0
Eastern Cape
Country [240] 0 0
South Africa
State/province [240] 0 0
Gauteng
Country [241] 0 0
South Africa
State/province [241] 0 0
Bellville
Country [242] 0 0
South Africa
State/province [242] 0 0
Benoni
Country [243] 0 0
South Africa
State/province [243] 0 0
Cape Town
Country [244] 0 0
South Africa
State/province [244] 0 0
Claremont
Country [245] 0 0
South Africa
State/province [245] 0 0
Die Wilgers
Country [246] 0 0
South Africa
State/province [246] 0 0
Durban
Country [247] 0 0
South Africa
State/province [247] 0 0
Gatesville
Country [248] 0 0
South Africa
State/province [248] 0 0
Middelburg
Country [249] 0 0
South Africa
State/province [249] 0 0
Pretoria
Country [250] 0 0
South Africa
State/province [250] 0 0
Somerset West
Country [251] 0 0
South Africa
State/province [251] 0 0
Soweto
Country [252] 0 0
South Africa
State/province [252] 0 0
Thabazimbi
Country [253] 0 0
South Africa
State/province [253] 0 0
Welkom
Country [254] 0 0
Spain
State/province [254] 0 0
Barcelona
Country [255] 0 0
Spain
State/province [255] 0 0
Basurto/Bilbao
Country [256] 0 0
Spain
State/province [256] 0 0
Burgos
Country [257] 0 0
Spain
State/province [257] 0 0
Canet De Mar - Barcelona
Country [258] 0 0
Spain
State/province [258] 0 0
Cádiz
Country [259] 0 0
Spain
State/province [259] 0 0
Elche
Country [260] 0 0
Spain
State/province [260] 0 0
Illescas-Toledo
Country [261] 0 0
Spain
State/province [261] 0 0
La Coruña
Country [262] 0 0
Spain
State/province [262] 0 0
Lleida
Country [263] 0 0
Spain
State/province [263] 0 0
Madrid
Country [264] 0 0
Spain
State/province [264] 0 0
Majadahonda (Madrid)
Country [265] 0 0
Spain
State/province [265] 0 0
Mataro
Country [266] 0 0
Spain
State/province [266] 0 0
Pozuelo De Alarcón/Madrid
Country [267] 0 0
Spain
State/province [267] 0 0
Sabadell (Barcelona)
Country [268] 0 0
Spain
State/province [268] 0 0
Sagunto/Valencia
Country [269] 0 0
Spain
State/province [269] 0 0
Sant Boi de Llobregat
Country [270] 0 0
Spain
State/province [270] 0 0
Santiago de Compostela
Country [271] 0 0
Spain
State/province [271] 0 0
Tarrasa, Barcelona
Country [272] 0 0
Spain
State/province [272] 0 0
Torrelavega
Country [273] 0 0
Spain
State/province [273] 0 0
Valencia
Country [274] 0 0
Spain
State/province [274] 0 0
Valladolid
Country [275] 0 0
Spain
State/province [275] 0 0
Vic (Barcelona)
Country [276] 0 0
Taiwan
State/province [276] 0 0
Kaohsiung
Country [277] 0 0
Taiwan
State/province [277] 0 0
Keelung
Country [278] 0 0
Taiwan
State/province [278] 0 0
Koahsiung
Country [279] 0 0
Taiwan
State/province [279] 0 0
Putzu
Country [280] 0 0
Taiwan
State/province [280] 0 0
Taipei
Country [281] 0 0
Ukraine
State/province [281] 0 0
Cherkassy
Country [282] 0 0
Ukraine
State/province [282] 0 0
Dnipropetrovsk
Country [283] 0 0
Ukraine
State/province [283] 0 0
Donetsk
Country [284] 0 0
Ukraine
State/province [284] 0 0
Ivano-Frankivsk
Country [285] 0 0
Ukraine
State/province [285] 0 0
Kharkiv
Country [286] 0 0
Ukraine
State/province [286] 0 0
Kiev
Country [287] 0 0
Ukraine
State/province [287] 0 0
Kryvyi Rih
Country [288] 0 0
Ukraine
State/province [288] 0 0
Kyiv
Country [289] 0 0
Ukraine
State/province [289] 0 0
Lviv
Country [290] 0 0
Ukraine
State/province [290] 0 0
Odesa
Country [291] 0 0
Ukraine
State/province [291] 0 0
Poltava
Country [292] 0 0
Ukraine
State/province [292] 0 0
Simferopol
Country [293] 0 0
Ukraine
State/province [293] 0 0
Sumy
Country [294] 0 0
Ukraine
State/province [294] 0 0
Ternopil
Country [295] 0 0
Ukraine
State/province [295] 0 0
Vinnytsia
Country [296] 0 0
Ukraine
State/province [296] 0 0
Zaporizhzhia
Country [297] 0 0
Ukraine
State/province [297] 0 0
Zaporizhzhya
Country [298] 0 0
Ukraine
State/province [298] 0 0
Zhytomyr
Country [299] 0 0
United Kingdom
State/province [299] 0 0
Bedfordshire
Country [300] 0 0
United Kingdom
State/province [300] 0 0
Glamorgan
Country [301] 0 0
United Kingdom
State/province [301] 0 0
Greater Manchester
Country [302] 0 0
United Kingdom
State/province [302] 0 0
Merseyside
Country [303] 0 0
United Kingdom
State/province [303] 0 0
Somerset
Country [304] 0 0
United Kingdom
State/province [304] 0 0
Sussex East
Country [305] 0 0
United Kingdom
State/province [305] 0 0
Barry
Country [306] 0 0
United Kingdom
State/province [306] 0 0
Bexhill-on-Sea
Country [307] 0 0
United Kingdom
State/province [307] 0 0
Chertsey, Surrey
Country [308] 0 0
United Kingdom
State/province [308] 0 0
Glasgow
Country [309] 0 0
United Kingdom
State/province [309] 0 0
Kent
Country [310] 0 0
United Kingdom
State/province [310] 0 0
Leicester
Country [311] 0 0
United Kingdom
State/province [311] 0 0
London
Country [312] 0 0
United Kingdom
State/province [312] 0 0
Penzance
Country [313] 0 0
United Kingdom
State/province [313] 0 0
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
Trial website
Trial related presentations / publications
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01475721