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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.
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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
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Secondary ID [1]
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115359
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Universal Trial Number (UTN)
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Trial acronym
AUSTRI
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Asthma
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Condition category
Condition code
Respiratory
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0
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Asthma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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)
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Assessment method [1]
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Composite endpoint was defined as clinically relevant endpoint that is constructed from combinations of other clinically relevant endpoints of serious asthma outcomes (i.e., asthma-related hospitalization, asthma-related endotracheal intubation, or asthma-related death). Hospitalization was defined as an inpatient stay or a =24-hour stay in an observation area in an emergency department or other equivalent facility. Probability of having event was summarized with Kaplan-Meier estimates.Hazard ratio, confidence interval, and p-value are from a stratified Cox proportional hazard model, using randomization stratum as the stratification factor. The 95% CI provided in the table is actually the 95.
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Timepoint [1]
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From Day 1 up to 26 weeks
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Primary outcome [2]
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Number of Participants Experiencing at Least One Asthma Exacerbation
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Assessment method [2]
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An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
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Timepoint [2]
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From Day 1 up to 26 weeks
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Secondary outcome [1]
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Number of Participants Experiencing at Least One Asthma Related Hospitalization , Endotracheal Intubation and Death
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Assessment method [1]
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Hospitalization was defined as an inpatient stay or a =24-hour stay in an observation area in an emergency department or other equivalent facility.
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Timepoint [1]
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From Day 1 up to 26 weeks
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Secondary outcome [2]
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Number of Participant Withdrawals From Study Treatment Due to Asthma Exacerbation
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Assessment method [2]
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An asthma exacerbation is defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least three days or an inpatient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
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Timepoint [2]
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From Day 1 up to 26 weeks
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Secondary outcome [3]
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Mean Rescue Medication (Albuterol/Salbutamol) Use as Puffs Per 24 Hours
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Assessment method [3]
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Rescue medication included albuterol/salbutamol used to treat acute asthma were reported as puffs per 24 hours over a period of 6 months.
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Timepoint [3]
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From Day 1 up to 26 weeks
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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
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Minimum age
12
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/11/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
23/06/2015
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Sample size
Target
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Accrual to date
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Final
11751
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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GSK Investigational Site - Broadmeadow
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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
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5042 - Bedford Park
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3168 - Clayton
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6008 - Subiaco
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3052 - Parkville
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Germany
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State/province [109]
0
0
Sachsen-Anhalt
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Sachsen
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Schleswig-Holstein
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Berlin
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Hamburg
Query!
Country [114]
0
0
Hungary
Query!
State/province [114]
0
0
Baja
Query!
Country [115]
0
0
Hungary
Query!
State/province [115]
0
0
Balassagyarmat
Query!
Country [116]
0
0
Hungary
Query!
State/province [116]
0
0
Budapest
Query!
Country [117]
0
0
Hungary
Query!
State/province [117]
0
0
Debrecen
Query!
Country [118]
0
0
Hungary
Query!
State/province [118]
0
0
Kaposvár
Query!
Country [119]
0
0
Hungary
Query!
State/province [119]
0
0
Komló
Query!
Country [120]
0
0
Hungary
Query!
State/province [120]
0
0
Mosonmagyaróvár
Query!
Country [121]
0
0
Hungary
Query!
State/province [121]
0
0
Nagykanizsa
Query!
Country [122]
0
0
Hungary
Query!
State/province [122]
0
0
Rackeve
Query!
Country [123]
0
0
Hungary
Query!
State/province [123]
0
0
Siófok
Query!
Country [124]
0
0
Hungary
Query!
State/province [124]
0
0
Szolnok
Query!
Country [125]
0
0
Indonesia
Query!
State/province [125]
0
0
Denpasar
Query!
Country [126]
0
0
Indonesia
Query!
State/province [126]
0
0
Depok Timur
Query!
Country [127]
0
0
Indonesia
Query!
State/province [127]
0
0
Jakarta
Query!
Country [128]
0
0
Indonesia
Query!
State/province [128]
0
0
Malang
Query!
Country [129]
0
0
Indonesia
Query!
State/province [129]
0
0
Medan
Query!
Country [130]
0
0
Indonesia
Query!
State/province [130]
0
0
Palembang
Query!
Country [131]
0
0
Indonesia
Query!
State/province [131]
0
0
Semarang
Query!
Country [132]
0
0
Indonesia
Query!
State/province [132]
0
0
Surakarta
Query!
Country [133]
0
0
Italy
Query!
State/province [133]
0
0
Emilia-Romagna
Query!
Country [134]
0
0
Italy
Query!
State/province [134]
0
0
Lazio
Query!
Country [135]
0
0
Italy
Query!
State/province [135]
0
0
Liguria
Query!
Country [136]
0
0
Italy
Query!
State/province [136]
0
0
Lombardia
Query!
Country [137]
0
0
Italy
Query!
State/province [137]
0
0
Sicilia
Query!
Country [138]
0
0
Italy
Query!
State/province [138]
0
0
Toscana
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
Brescia
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Messina
Query!
Country [141]
0
0
Italy
Query!
State/province [141]
0
0
Milano
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Monza
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Roma
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Sesto San Giovanni
Query!
Country [145]
0
0
Korea, Republic of
Query!
State/province [145]
0
0
Bucheon-si,
Query!
Country [146]
0
0
Korea, Republic of
Query!
State/province [146]
0
0
Bucheon
Query!
Country [147]
0
0
Korea, Republic of
Query!
State/province [147]
0
0
Busan
Query!
Country [148]
0
0
Korea, Republic of
Query!
State/province [148]
0
0
Chuncheon
Query!
Country [149]
0
0
Korea, Republic of
Query!
State/province [149]
0
0
Gwangju
Query!
Country [150]
0
0
Korea, Republic of
Query!
State/province [150]
0
0
Incheon
Query!
Country [151]
0
0
Korea, Republic of
Query!
State/province [151]
0
0
Seoul
Query!
Country [152]
0
0
Latvia
Query!
State/province [152]
0
0
Kuldiga
Query!
Country [153]
0
0
Latvia
Query!
State/province [153]
0
0
Riga
Query!
Country [154]
0
0
Latvia
Query!
State/province [154]
0
0
Tukums
Query!
Country [155]
0
0
Lithuania
Query!
State/province [155]
0
0
Kaunas
Query!
Country [156]
0
0
Lithuania
Query!
State/province [156]
0
0
Klaipeda
Query!
Country [157]
0
0
Lithuania
Query!
State/province [157]
0
0
Siauliai
Query!
Country [158]
0
0
Lithuania
Query!
State/province [158]
0
0
Utena
Query!
Country [159]
0
0
Lithuania
Query!
State/province [159]
0
0
Vilnius
Query!
Country [160]
0
0
Malaysia
Query!
State/province [160]
0
0
Alor Setar
Query!
Country [161]
0
0
Malaysia
Query!
State/province [161]
0
0
Kota Bharu
Query!
Country [162]
0
0
Malaysia
Query!
State/province [162]
0
0
Kuala Pilah
Query!
Country [163]
0
0
Malaysia
Query!
State/province [163]
0
0
Selangor
Query!
Country [164]
0
0
Malaysia
Query!
State/province [164]
0
0
Sungai Buloh
Query!
Country [165]
0
0
Mexico
Query!
State/province [165]
0
0
Aguascalientes
Query!
Country [166]
0
0
Mexico
Query!
State/province [166]
0
0
Jalisco
Query!
Country [167]
0
0
Mexico
Query!
State/province [167]
0
0
Chihuahua
Query!
Country [168]
0
0
Mexico
Query!
State/province [168]
0
0
Huixquilucan
Query!
Country [169]
0
0
Mexico
Query!
State/province [169]
0
0
Monterrey
Query!
Country [170]
0
0
Mexico
Query!
State/province [170]
0
0
Zapopan
Query!
Country [171]
0
0
Peru
Query!
State/province [171]
0
0
Lima
Query!
Country [172]
0
0
Peru
Query!
State/province [172]
0
0
San Borja, Lima
Query!
Country [173]
0
0
Philippines
Query!
State/province [173]
0
0
Dasmariñas, Cavite
Query!
Country [174]
0
0
Philippines
Query!
State/province [174]
0
0
Davao
Query!
Country [175]
0
0
Philippines
Query!
State/province [175]
0
0
Las Pinas
Query!
Country [176]
0
0
Philippines
Query!
State/province [176]
0
0
Los Banos
Query!
Country [177]
0
0
Philippines
Query!
State/province [177]
0
0
Pulilan
Query!
Country [178]
0
0
Philippines
Query!
State/province [178]
0
0
Quezon City
Query!
Country [179]
0
0
Poland
Query!
State/province [179]
0
0
Bielsko-Biala
Query!
Country [180]
0
0
Poland
Query!
State/province [180]
0
0
Brzesko
Query!
Country [181]
0
0
Poland
Query!
State/province [181]
0
0
Bydgoszcz
Query!
Country [182]
0
0
Poland
Query!
State/province [182]
0
0
Bystra
Query!
Country [183]
0
0
Poland
Query!
State/province [183]
0
0
Cieszyn
Query!
Country [184]
0
0
Poland
Query!
State/province [184]
0
0
Debica
Query!
Country [185]
0
0
Poland
Query!
State/province [185]
0
0
Elblag
Query!
Country [186]
0
0
Poland
Query!
State/province [186]
0
0
Gdanska
Query!
Country [187]
0
0
Poland
Query!
State/province [187]
0
0
Gdansk
Query!
Country [188]
0
0
Poland
Query!
State/province [188]
0
0
Glucholazy
Query!
Country [189]
0
0
Poland
Query!
State/province [189]
0
0
Jelenia Gora
Query!
Country [190]
0
0
Poland
Query!
State/province [190]
0
0
Krakow
Query!
Country [191]
0
0
Poland
Query!
State/province [191]
0
0
Libiaz
Query!
Country [192]
0
0
Poland
Query!
State/province [192]
0
0
Lodz
Query!
Country [193]
0
0
Poland
Query!
State/province [193]
0
0
Lubin
Query!
Country [194]
0
0
Poland
Query!
State/province [194]
0
0
Lublin
Query!
Country [195]
0
0
Poland
Query!
State/province [195]
0
0
Olsztyn
Query!
Country [196]
0
0
Poland
Query!
State/province [196]
0
0
Poznan
Query!
Country [197]
0
0
Poland
Query!
State/province [197]
0
0
Radomsko
Query!
Country [198]
0
0
Poland
Query!
State/province [198]
0
0
Ruda Slaska
Query!
Country [199]
0
0
Poland
Query!
State/province [199]
0
0
Rudka
Query!
Country [200]
0
0
Poland
Query!
State/province [200]
0
0
Rzeszow
Query!
Country [201]
0
0
Poland
Query!
State/province [201]
0
0
Sandomierz
Query!
Country [202]
0
0
Poland
Query!
State/province [202]
0
0
Sopot
Query!
Country [203]
0
0
Poland
Query!
State/province [203]
0
0
Szczecin
Query!
Country [204]
0
0
Poland
Query!
State/province [204]
0
0
Warszawa
Query!
Country [205]
0
0
Poland
Query!
State/province [205]
0
0
Wodzislaw Slaski
Query!
Country [206]
0
0
Poland
Query!
State/province [206]
0
0
Wolomin
Query!
Country [207]
0
0
Poland
Query!
State/province [207]
0
0
Wroclaw
Query!
Country [208]
0
0
Poland
Query!
State/province [208]
0
0
Zabrze
Query!
Country [209]
0
0
Poland
Query!
State/province [209]
0
0
Zgierz
Query!
Country [210]
0
0
Romania
Query!
State/province [210]
0
0
Brasov
Query!
Country [211]
0
0
Romania
Query!
State/province [211]
0
0
Cluj-Napoca
Query!
Country [212]
0
0
Romania
Query!
State/province [212]
0
0
Sibiu
Query!
Country [213]
0
0
Russian Federation
Query!
State/province [213]
0
0
Chelyabinsk
Query!
Country [214]
0
0
Russian Federation
Query!
State/province [214]
0
0
Kemerovo
Query!
Country [215]
0
0
Russian Federation
Query!
State/province [215]
0
0
Kirov
Query!
Country [216]
0
0
Russian Federation
Query!
State/province [216]
0
0
Krasnodar
Query!
Country [217]
0
0
Russian Federation
Query!
State/province [217]
0
0
Krasnoyarsk
Query!
Country [218]
0
0
Russian Federation
Query!
State/province [218]
0
0
Moscow
Query!
Country [219]
0
0
Russian Federation
Query!
State/province [219]
0
0
Novgorod
Query!
Country [220]
0
0
Russian Federation
Query!
State/province [220]
0
0
Novosibirsk
Query!
Country [221]
0
0
Russian Federation
Query!
State/province [221]
0
0
Orenburg
Query!
Country [222]
0
0
Russian Federation
Query!
State/province [222]
0
0
Pyatigorsk
Query!
Country [223]
0
0
Russian Federation
Query!
State/province [223]
0
0
Rostov-on-Don
Query!
Country [224]
0
0
Russian Federation
Query!
State/province [224]
0
0
Ryazan
Query!
Country [225]
0
0
Russian Federation
Query!
State/province [225]
0
0
Saint Petersburg
Query!
Country [226]
0
0
Russian Federation
Query!
State/province [226]
0
0
Saint-Petersburg
Query!
Country [227]
0
0
Russian Federation
Query!
State/province [227]
0
0
Saratov
Query!
Country [228]
0
0
Russian Federation
Query!
State/province [228]
0
0
St. Petersburg
Query!
Country [229]
0
0
Russian Federation
Query!
State/province [229]
0
0
Tomsk
Query!
Country [230]
0
0
Russian Federation
Query!
State/province [230]
0
0
Voronezh
Query!
Country [231]
0
0
Russian Federation
Query!
State/province [231]
0
0
Yaroslavl
Query!
Country [232]
0
0
Serbia
Query!
State/province [232]
0
0
Belgrade
Query!
Country [233]
0
0
Slovakia
Query!
State/province [233]
0
0
Kosice
Query!
Country [234]
0
0
Slovakia
Query!
State/province [234]
0
0
Kralovsky Chlmec
Query!
Country [235]
0
0
Slovakia
Query!
State/province [235]
0
0
Levice
Query!
Country [236]
0
0
Slovakia
Query!
State/province [236]
0
0
Martin
Query!
Country [237]
0
0
Slovakia
Query!
State/province [237]
0
0
Sturovo
Query!
Country [238]
0
0
Slovakia
Query!
State/province [238]
0
0
Trnava
Query!
Country [239]
0
0
South Africa
Query!
State/province [239]
0
0
Eastern Cape
Query!
Country [240]
0
0
South Africa
Query!
State/province [240]
0
0
Gauteng
Query!
Country [241]
0
0
South Africa
Query!
State/province [241]
0
0
Bellville
Query!
Country [242]
0
0
South Africa
Query!
State/province [242]
0
0
Benoni
Query!
Country [243]
0
0
South Africa
Query!
State/province [243]
0
0
Cape Town
Query!
Country [244]
0
0
South Africa
Query!
State/province [244]
0
0
Claremont
Query!
Country [245]
0
0
South Africa
Query!
State/province [245]
0
0
Die Wilgers
Query!
Country [246]
0
0
South Africa
Query!
State/province [246]
0
0
Durban
Query!
Country [247]
0
0
South Africa
Query!
State/province [247]
0
0
Gatesville
Query!
Country [248]
0
0
South Africa
Query!
State/province [248]
0
0
Middelburg
Query!
Country [249]
0
0
South Africa
Query!
State/province [249]
0
0
Pretoria
Query!
Country [250]
0
0
South Africa
Query!
State/province [250]
0
0
Somerset West
Query!
Country [251]
0
0
South Africa
Query!
State/province [251]
0
0
Soweto
Query!
Country [252]
0
0
South Africa
Query!
State/province [252]
0
0
Thabazimbi
Query!
Country [253]
0
0
South Africa
Query!
State/province [253]
0
0
Welkom
Query!
Country [254]
0
0
Spain
Query!
State/province [254]
0
0
Barcelona
Query!
Country [255]
0
0
Spain
Query!
State/province [255]
0
0
Basurto/Bilbao
Query!
Country [256]
0
0
Spain
Query!
State/province [256]
0
0
Burgos
Query!
Country [257]
0
0
Spain
Query!
State/province [257]
0
0
Canet De Mar - Barcelona
Query!
Country [258]
0
0
Spain
Query!
State/province [258]
0
0
Cádiz
Query!
Country [259]
0
0
Spain
Query!
State/province [259]
0
0
Elche
Query!
Country [260]
0
0
Spain
Query!
State/province [260]
0
0
Illescas-Toledo
Query!
Country [261]
0
0
Spain
Query!
State/province [261]
0
0
La Coruña
Query!
Country [262]
0
0
Spain
Query!
State/province [262]
0
0
Lleida
Query!
Country [263]
0
0
Spain
Query!
State/province [263]
0
0
Madrid
Query!
Country [264]
0
0
Spain
Query!
State/province [264]
0
0
Majadahonda (Madrid)
Query!
Country [265]
0
0
Spain
Query!
State/province [265]
0
0
Mataro
Query!
Country [266]
0
0
Spain
Query!
State/province [266]
0
0
Pozuelo De Alarcón/Madrid
Query!
Country [267]
0
0
Spain
Query!
State/province [267]
0
0
Sabadell (Barcelona)
Query!
Country [268]
0
0
Spain
Query!
State/province [268]
0
0
Sagunto/Valencia
Query!
Country [269]
0
0
Spain
Query!
State/province [269]
0
0
Sant Boi de Llobregat
Query!
Country [270]
0
0
Spain
Query!
State/province [270]
0
0
Santiago de Compostela
Query!
Country [271]
0
0
Spain
Query!
State/province [271]
0
0
Tarrasa, Barcelona
Query!
Country [272]
0
0
Spain
Query!
State/province [272]
0
0
Torrelavega
Query!
Country [273]
0
0
Spain
Query!
State/province [273]
0
0
Valencia
Query!
Country [274]
0
0
Spain
Query!
State/province [274]
0
0
Valladolid
Query!
Country [275]
0
0
Spain
Query!
State/province [275]
0
0
Vic (Barcelona)
Query!
Country [276]
0
0
Taiwan
Query!
State/province [276]
0
0
Kaohsiung
Query!
Country [277]
0
0
Taiwan
Query!
State/province [277]
0
0
Keelung
Query!
Country [278]
0
0
Taiwan
Query!
State/province [278]
0
0
Koahsiung
Query!
Country [279]
0
0
Taiwan
Query!
State/province [279]
0
0
Putzu
Query!
Country [280]
0
0
Taiwan
Query!
State/province [280]
0
0
Taipei
Query!
Country [281]
0
0
Ukraine
Query!
State/province [281]
0
0
Cherkassy
Query!
Country [282]
0
0
Ukraine
Query!
State/province [282]
0
0
Dnipropetrovsk
Query!
Country [283]
0
0
Ukraine
Query!
State/province [283]
0
0
Donetsk
Query!
Country [284]
0
0
Ukraine
Query!
State/province [284]
0
0
Ivano-Frankivsk
Query!
Country [285]
0
0
Ukraine
Query!
State/province [285]
0
0
Kharkiv
Query!
Country [286]
0
0
Ukraine
Query!
State/province [286]
0
0
Kiev
Query!
Country [287]
0
0
Ukraine
Query!
State/province [287]
0
0
Kryvyi Rih
Query!
Country [288]
0
0
Ukraine
Query!
State/province [288]
0
0
Kyiv
Query!
Country [289]
0
0
Ukraine
Query!
State/province [289]
0
0
Lviv
Query!
Country [290]
0
0
Ukraine
Query!
State/province [290]
0
0
Odesa
Query!
Country [291]
0
0
Ukraine
Query!
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Poltava
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Ukraine
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Simferopol
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Ukraine
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Sumy
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Ukraine
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Ternopil
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia
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Ukraine
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Zaporizhzhya
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Ukraine
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Zhytomyr
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United Kingdom
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Bedfordshire
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United Kingdom
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Glamorgan
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United Kingdom
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Greater Manchester
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United Kingdom
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Merseyside
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United Kingdom
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Somerset
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United Kingdom
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Sussex East
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United Kingdom
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Barry
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Bexhill-on-Sea
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Chertsey, Surrey
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United Kingdom
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Glasgow
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United Kingdom
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Kent
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United Kingdom
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Leicester
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United Kingdom
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London
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United Kingdom
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Penzance
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United Kingdom
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Stoke on Trent
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Commercial sector/industry
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Parexel
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01475721
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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.
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Public notes
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Contacts
Principal investigator
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GSK Clinical Trials
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GlaxoSmithKline
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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.
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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