Last updated: 11/04/2018 04:29:18

A Comparative Study To Determine If Motivating Asthma Education (Compliance Enhancement) Has An Effect On Asthma Control

GSK study ID
ACE104325
See study documents
Clinicaltrials.gov ID
NCT00351143
EudraCT ID
Not applicable
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: A randomized, open label comparative study to determine the proportion of asthma patients on SERETIDE Diskus 50/250 mcg b.i.d. achieving Total Control when given medication and compliance enhancement training compared to those receiving medication only
Trial description: This study will investigate whether study subjects with previously uncontrolled asthma treated with SERETIDE Diskus 50/250 CCI18781+GR33343 mcg twice a day can attain a level of Total Control of their condition and whether adherence to treatment can be enhanced by teaching the subjects. Two groups of equal size with identical medical treatment will be compared with each other, the test group receiving three training modules during study visits and the control group regular study visits only.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

number of subjects who achieved Total asthma Control: Period 2

Timeframe: Up to Week 24

Secondary outcomes:

Number of subjects who achieved Total Control with salmeterol/fluticasone propionate 50/250 g b.i.d. fixed dosing: Period 2

Timeframe: Up to Week 12

Time to first individual week with Total Control

Timeframe: Up to Week 24

Morning peak expiratory flow (PEF)

Timeframe: Up to Week 24

Forced expiratory volume in one second (FEV1)

Timeframe: Up to Week 24

Asthma symptom score

Timeframe: Up to Week 24

Number of subjects using rescue medication

Timeframe: Up to Week 24

Number of nights with awakening due to asthma

Timeframe: Up to Week 24

Asthma severity score

Timeframe: Up to Week 24

Number of subjects with adverse events (AEs)

Timeframe: Up to Week 24

AQLQ score

Timeframe: Up to Week 24

Interventions:
  • Drug: salmeterol/fluticasone propionate 50/250 µg + 3 training sessions of compliance enhancement training
  • Drug: salmeterol/fluticasone propionate 50/250 µg
    • Enrollment:
    274
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    July 2005 to June 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosed with persistent asthma.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Diagnosed with persistent asthma.
    • Not treated with the combination of a ICS (inhaled corticosteroid)and a LABA (long-acting beta-agonist).
    • Female subjects must not be fertile or must use effective contraception.
    • Subject must be able to comply with the use of the questionnaires in the local language. Exclusion criteria:
    • Known or suspected Chronic Obstructive Pulmonary Disease.
    • Pregnant or lactating.
    • Participating investigator, employee of an investigator, or family member of any of the aforementioned.
    • Smoking history: Pack-years > 10 years.
    • Have known clinical or laboratory evidence of a serious uncontrolled systemic disease.
    • Known hypersensitivity to any substance contained in investigational product or as-needed medication.
    • Treatment with oral corticosteroid within 2 months prior to the screening visit.
    • Upper or lower respiratory tract infection (microbiologically verified) within 1 month prior to screening visit.
    • Acute asthma exacerbation requiring hospitalisation or emergency room treatment within 3 months prior to the screening visit.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Pregassona, Switzerland, 6963
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Thun, Switzerland, 3600
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Wigoltingen, Switzerland, 8556
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Basel, Switzerland, 4054
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Aarhus C, Denmark, DK-8000
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Klosters, Switzerland, 7250
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 32 Results

    Study documents

    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

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2007-13-06

    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

    Additional information
    Not applicable
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