Last updated: 07/17/2024 15:44:10

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.AUSTRI

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GSK study ID
115359
See study documents
Clinicaltrials.gov ID
NCT01475721
See results summary
EudraCT ID
2011-001644-29
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Allocation:
Randomized
Primary outcomes:

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)

Timeframe: From Day 1 up to 26 weeks

Number of participants experiencing at least one asthma exacerbation

Timeframe: From Day 1 up to 26 weeks

Secondary outcomes:

Number of participants experiencing at least one asthma related hospitalization , endotracheal intubation and death

Timeframe: From Day 1 up to 26 weeks

Number of participant withdrawals from study treatment due to asthma exacerbation

Timeframe: From Day 1 up to 26 weeks

Mean rescue medication (albuterol/salbutamol) use as puffs per 24 hours

Timeframe: From Day 1 up to 26 weeks

Interventions:
  • Drug: ADVAIR 100/50mcg
  • Drug: ADVAIR 250/50mcg
  • Drug: ADVAIR 500/50mcg
  • Drug: FLOVENT 100mcg
  • Drug: FLOVENT 250mcg
  • Drug: FLOVENT 500mcg
    • Enrollment:
    11751
    Primary completion date:
    2015-23-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Stempel D, Raphiou I, Kral, K, Yeakey A, Emmett A, Prazma C, Buaron K, Pascoe S.Serious Asthma Events with Fluticasone plus Salmeterol versus Fluticasone Alone.N Engl J Med.2016;374:1822-1830.
    Stanley Szefler, Ibrahim Raphiou, Robert S. Zeiger, David Stempel, Kenneth Kral, Steven Pascoe.Seasonal variation in asthma exacerbations in the AUSTRI and VESTRI studies .ERJ Open Res.2019;5:1-4 DOI: 10.1183/23120541.00153-2018
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Parexel
    Study date(s)
    November 2011 to June 2015
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Provided consent to participate in the study
    • Male or female, 12 years of age and older
    • 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
    Inclusion and exclusion criteria
    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
    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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    ALOR SETAR, Malaysia, 05460
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Aguascalientes, Ags, Aguascalientes, Mexico, 20127
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albuquerque, New Mexico, United States, 87131
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Anaheim, California, United States, 92801
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Anaheim, California, United States, 92804
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ann Arbor, Michigan, United States, 48106
    Status
    Study Complete
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    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2015-23-06
    Actual study completion date
    2015-23-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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