Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Recruitment hospital [5] 0 0
GSK Investigational Site - Redcliffe
Recruitment hospital [6] 0 0
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
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4066 - Auchenflower
Recruitment postcode(s) [5] 0 0
4020 - Redcliffe
Recruitment postcode(s) [6] 0 0
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
District of Columbia
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Louisiana
Country [15] 0 0
United States of America
State/province [15] 0 0
Maine
Country [16] 0 0
United States of America
State/province [16] 0 0
Maryland
Country [17] 0 0
United States of America
State/province [17] 0 0
Massachusetts
Country [18] 0 0
United States of America
State/province [18] 0 0
Michigan
Country [19] 0 0
United States of America
State/province [19] 0 0
Minnesota
Country [20] 0 0
United States of America
State/province [20] 0 0
Mississippi
Country [21] 0 0
United States of America
State/province [21] 0 0
Missouri
Country [22] 0 0
United States of America
State/province [22] 0 0
Montana
Country [23] 0 0
United States of America
State/province [23] 0 0
Nebraska
Country [24] 0 0
United States of America
State/province [24] 0 0
Nevada
Country [25] 0 0
United States of America
State/province [25] 0 0
New Jersey
Country [26] 0 0
United States of America
State/province [26] 0 0
New Mexico
Country [27] 0 0
United States of America
State/province [27] 0 0
New York
Country [28] 0 0
United States of America
State/province [28] 0 0
North Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
North Dakota
Country [30] 0 0
United States of America
State/province [30] 0 0
Ohio
Country [31] 0 0
United States of America
State/province [31] 0 0
Oklahoma
Country [32] 0 0
United States of America
State/province [32] 0 0
Oregon
Country [33] 0 0
United States of America
State/province [33] 0 0
Pennsylvania
Country [34] 0 0
United States of America
State/province [34] 0 0
Rhode Island
Country [35] 0 0
United States of America
State/province [35] 0 0
South Carolina
Country [36] 0 0
United States of America
State/province [36] 0 0
South Dakota
Country [37] 0 0
United States of America
State/province [37] 0 0
Tennessee
Country [38] 0 0
United States of America
State/province [38] 0 0
Texas
Country [39] 0 0
United States of America
State/province [39] 0 0
Utah
Country [40] 0 0
United States of America
State/province [40] 0 0
Vermont
Country [41] 0 0
United States of America
State/province [41] 0 0
Virginia
Country [42] 0 0
United States of America
State/province [42] 0 0
Washington
Country [43] 0 0
United States of America
State/province [43] 0 0
West Virginia
Country [44] 0 0
United States of America
State/province [44] 0 0
Wisconsin
Country [45] 0 0
Argentina
State/province [45] 0 0
Buenos Aires
Country [46] 0 0
Argentina
State/province [46] 0 0
Entre Ríos
Country [47] 0 0
Argentina
State/province [47] 0 0
Santa Fe
Country [48] 0 0
Argentina
State/province [48] 0 0
Tucumán
Country [49] 0 0
Argentina
State/province [49] 0 0
Ciudad Autónoma de Buenos Aires
Country [50] 0 0
Argentina
State/province [50] 0 0
La Plata
Country [51] 0 0
Argentina
State/province [51] 0 0
Lanús
Country [52] 0 0
Argentina
State/province [52] 0 0
Mendoza
Country [53] 0 0
Argentina
State/province [53] 0 0
Rosario
Country [54] 0 0
Austria
State/province [54] 0 0
Feldkirch
Country [55] 0 0
Austria
State/province [55] 0 0
Salzburg
Country [56] 0 0
Austria
State/province [56] 0 0
Vienna
Country [57] 0 0
Austria
State/province [57] 0 0
Wels
Country [58] 0 0
Austria
State/province [58] 0 0
Wien
Country [59] 0 0
Belgium
State/province [59] 0 0
Brussels
Country [60] 0 0
Belgium
State/province [60] 0 0
Bruxelles
Country [61] 0 0
Belgium
State/province [61] 0 0
Hamois (Natoye)
Country [62] 0 0
Belgium
State/province [62] 0 0
Jambes
Country [63] 0 0
Belgium
State/province [63] 0 0
Leuven
Country [64] 0 0
Belgium
State/province [64] 0 0
Montigny-Le-Tilleul
Country [65] 0 0
Bulgaria
State/province [65] 0 0
Blagoevgrad
Country [66] 0 0
Bulgaria
State/province [66] 0 0
Pazardjik
Country [67] 0 0
Bulgaria
State/province [67] 0 0
Plovdiv
Country [68] 0 0
Bulgaria
State/province [68] 0 0
Sliven
Country [69] 0 0
Bulgaria
State/province [69] 0 0
Sofia
Country [70] 0 0
Bulgaria
State/province [70] 0 0
Troyan
Country [71] 0 0
Bulgaria
State/province [71] 0 0
Varna
Country [72] 0 0
Bulgaria
State/province [72] 0 0
Veliko Tarnovo
Country [73] 0 0
Bulgaria
State/province [73] 0 0
Vidin
Country [74] 0 0
Canada
State/province [74] 0 0
Alberta
Country [75] 0 0
Canada
State/province [75] 0 0
British Columbia
Country [76] 0 0
Canada
State/province [76] 0 0
Ontario
Country [77] 0 0
Chile
State/province [77] 0 0
Región De La Araucania
Country [78] 0 0
Chile
State/province [78] 0 0
Valparaíso
Country [79] 0 0
Chile
State/province [79] 0 0
Santiago
Country [80] 0 0
Chile
State/province [80] 0 0
Valdivia
Country [81] 0 0
Chile
State/province [81] 0 0
Viña del Mar
Country [82] 0 0
Colombia
State/province [82] 0 0
Bogota
Country [83] 0 0
Colombia
State/province [83] 0 0
Bucaramanga
Country [84] 0 0
Croatia
State/province [84] 0 0
Cakovec
Country [85] 0 0
Croatia
State/province [85] 0 0
Senj
Country [86] 0 0
Croatia
State/province [86] 0 0
Zadar
Country [87] 0 0
Croatia
State/province [87] 0 0
Zagreb
Country [88] 0 0
Czechia
State/province [88] 0 0
Havlickuv brod
Country [89] 0 0
Czechia
State/province [89] 0 0
Hlucin
Country [90] 0 0
Czechia
State/province [90] 0 0
Jaromer
Country [91] 0 0
Czechia
State/province [91] 0 0
Kyjov
Country [92] 0 0
Czechia
State/province [92] 0 0
Plzen
Country [93] 0 0
Czechia
State/province [93] 0 0
Praha 13
Country [94] 0 0
Czechia
State/province [94] 0 0
Praha 1
Country [95] 0 0
Czechia
State/province [95] 0 0
Praha 4
Country [96] 0 0
Czechia
State/province [96] 0 0
Praha 6
Country [97] 0 0
Czechia
State/province [97] 0 0
Svitavy
Country [98] 0 0
Czechia
State/province [98] 0 0
Tremosna
Country [99] 0 0
Denmark
State/province [99] 0 0
Copenhagen
Country [100] 0 0
Denmark
State/province [100] 0 0
Rosklide
Country [101] 0 0
Germany
State/province [101] 0 0
Baden-Wuerttemberg
Country [102] 0 0
Germany
State/province [102] 0 0
Bayern
Country [103] 0 0
Germany
State/province [103] 0 0
Brandenburg
Country [104] 0 0
Germany
State/province [104] 0 0
Hessen
Country [105] 0 0
Germany
State/province [105] 0 0
Niedersachsen
Country [106] 0 0
Germany
State/province [106] 0 0
Nordrhein-Westfalen
Country [107] 0 0
Germany
State/province [107] 0 0
Rheinland-Pfalz
Country [108] 0 0
Germany
State/province [108] 0 0
Saarland
Country [109] 0 0
Germany
State/province [109] 0 0
Sachsen-Anhalt
Country [110] 0 0
Germany
State/province [110] 0 0
Sachsen
Country [111] 0 0
Germany
State/province [111] 0 0
Schleswig-Holstein
Country [112] 0 0
Germany
State/province [112] 0 0
Berlin
Country [113] 0 0
Germany
State/province [113] 0 0
Hamburg
Country [114] 0 0
Hungary
State/province [114] 0 0
Baja
Country [115] 0 0
Hungary
State/province [115] 0 0
Balassagyarmat
Country [116] 0 0
Hungary
State/province [116] 0 0
Budapest
Country [117] 0 0
Hungary
State/province [117] 0 0
Debrecen
Country [118] 0 0
Hungary
State/province [118] 0 0
Kaposvár
Country [119] 0 0
Hungary
State/province [119] 0 0
Komló
Country [120] 0 0
Hungary
State/province [120] 0 0
Mosonmagyaróvár
Country [121] 0 0
Hungary
State/province [121] 0 0
Nagykanizsa
Country [122] 0 0
Hungary
State/province [122] 0 0
Rackeve
Country [123] 0 0
Hungary
State/province [123] 0 0
Siófok
Country [124] 0 0
Hungary
State/province [124] 0 0
Szolnok
Country [125] 0 0
Indonesia
State/province [125] 0 0
Denpasar
Country [126] 0 0
Indonesia
State/province [126] 0 0
Depok Timur
Country [127] 0 0
Indonesia
State/province [127] 0 0
Jakarta
Country [128] 0 0
Indonesia
State/province [128] 0 0
Malang
Country [129] 0 0
Indonesia
State/province [129] 0 0
Medan
Country [130] 0 0
Indonesia
State/province [130] 0 0
Palembang
Country [131] 0 0
Indonesia
State/province [131] 0 0
Semarang
Country [132] 0 0
Indonesia
State/province [132] 0 0
Surakarta
Country [133] 0 0
Italy
State/province [133] 0 0
Emilia-Romagna
Country [134] 0 0
Italy
State/province [134] 0 0
Lazio
Country [135] 0 0
Italy
State/province [135] 0 0
Liguria
Country [136] 0 0
Italy
State/province [136] 0 0
Lombardia
Country [137] 0 0
Italy
State/province [137] 0 0
Sicilia
Country [138] 0 0
Italy
State/province [138] 0 0
Toscana
Country [139] 0 0
Italy
State/province [139] 0 0
Brescia
Country [140] 0 0
Italy
State/province [140] 0 0
Messina
Country [141] 0 0
Italy
State/province [141] 0 0
Milano
Country [142] 0 0
Italy
State/province [142] 0 0
Monza
Country [143] 0 0
Italy
State/province [143] 0 0
Roma
Country [144] 0 0
Italy
State/province [144] 0 0
Sesto San Giovanni
Country [145] 0 0
Korea, Republic of
State/province [145] 0 0
Bucheon-si,
Country [146] 0 0
Korea, Republic of
State/province [146] 0 0
Bucheon
Country [147] 0 0
Korea, Republic of
State/province [147] 0 0
Busan
Country [148] 0 0
Korea, Republic of
State/province [148] 0 0
Chuncheon
Country [149] 0 0
Korea, Republic of
State/province [149] 0 0
Gwangju
Country [150] 0 0
Korea, Republic of
State/province [150] 0 0
Incheon
Country [151] 0 0
Korea, Republic of
State/province [151] 0 0
Seoul
Country [152] 0 0
Latvia
State/province [152] 0 0
Kuldiga
Country [153] 0 0
Latvia
State/province [153] 0 0
Riga
Country [154] 0 0
Latvia
State/province [154] 0 0
Tukums
Country [155] 0 0
Lithuania
State/province [155] 0 0
Kaunas
Country [156] 0 0
Lithuania
State/province [156] 0 0
Klaipeda
Country [157] 0 0
Lithuania
State/province [157] 0 0
Siauliai
Country [158] 0 0
Lithuania
State/province [158] 0 0
Utena
Country [159] 0 0
Lithuania
State/province [159] 0 0
Vilnius
Country [160] 0 0
Malaysia
State/province [160] 0 0
Alor Setar
Country [161] 0 0
Malaysia
State/province [161] 0 0
Kota Bharu
Country [162] 0 0
Malaysia
State/province [162] 0 0
Kuala Pilah
Country [163] 0 0
Malaysia
State/province [163] 0 0
Selangor
Country [164] 0 0
Malaysia
State/province [164] 0 0
Sungai Buloh
Country [165] 0 0
Mexico
State/province [165] 0 0
Aguascalientes
Country [166] 0 0
Mexico
State/province [166] 0 0
Jalisco
Country [167] 0 0
Mexico
State/province [167] 0 0
Chihuahua
Country [168] 0 0
Mexico
State/province [168] 0 0
Huixquilucan
Country [169] 0 0
Mexico
State/province [169] 0 0
Monterrey
Country [170] 0 0
Mexico
State/province [170] 0 0
Zapopan
Country [171] 0 0
Peru
State/province [171] 0 0
Lima
Country [172] 0 0
Peru
State/province [172] 0 0
San Borja, Lima
Country [173] 0 0
Philippines
State/province [173] 0 0
Dasmariñas, Cavite
Country [174] 0 0
Philippines
State/province [174] 0 0
Davao
Country [175] 0 0
Philippines
State/province [175] 0 0
Las Pinas
Country [176] 0 0
Philippines
State/province [176] 0 0
Los Banos
Country [177] 0 0
Philippines
State/province [177] 0 0
Pulilan
Country [178] 0 0
Philippines
State/province [178] 0 0
Quezon City
Country [179] 0 0
Poland
State/province [179] 0 0
Bielsko-Biala
Country [180] 0 0
Poland
State/province [180] 0 0
Brzesko
Country [181] 0 0
Poland
State/province [181] 0 0
Bydgoszcz
Country [182] 0 0
Poland
State/province [182] 0 0
Bystra
Country [183] 0 0
Poland
State/province [183] 0 0
Cieszyn
Country [184] 0 0
Poland
State/province [184] 0 0
Debica
Country [185] 0 0
Poland
State/province [185] 0 0
Elblag
Country [186] 0 0
Poland
State/province [186] 0 0
Gdanska
Country [187] 0 0
Poland
State/province [187] 0 0
Gdansk
Country [188] 0 0
Poland
State/province [188] 0 0
Glucholazy
Country [189] 0 0
Poland
State/province [189] 0 0
Jelenia Gora
Country [190] 0 0
Poland
State/province [190] 0 0
Krakow
Country [191] 0 0
Poland
State/province [191] 0 0
Libiaz
Country [192] 0 0
Poland
State/province [192] 0 0
Lodz
Country [193] 0 0
Poland
State/province [193] 0 0
Lubin
Country [194] 0 0
Poland
State/province [194] 0 0
Lublin
Country [195] 0 0
Poland
State/province [195] 0 0
Olsztyn
Country [196] 0 0
Poland
State/province [196] 0 0
Poznan
Country [197] 0 0
Poland
State/province [197] 0 0
Radomsko
Country [198] 0 0
Poland
State/province [198] 0 0
Ruda Slaska
Country [199] 0 0
Poland
State/province [199] 0 0
Rudka
Country [200] 0 0
Poland
State/province [200] 0 0
Rzeszow
Country [201] 0 0
Poland
State/province [201] 0 0
Sandomierz
Country [202] 0 0
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
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/ct2/show/NCT01475721
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01475721