Last updated: 11/04/2018 11:06:49

Results Of Patient Rated Asthma Control Test In Comparison To Diary Card Data

GSK study ID
SAM 106538
See study documents
Clinicaltrials.gov ID
NCT00363480
See results summary
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: Asthma control assessment via ACT and DRC in Asthmatics treated with Seretide (50/250) over 12 weeks
Trial description: The majority of asthma patients are not well controlled, despite the availability of asthma medication that could effectively treat the disease. In this study uncontrolled patients who are steroid-naive or on low dose inhaled corticosteroids will be treated with Seretide (salmeterol/fluticasone combination, SFC) 50/250 µg twice daily. The asthma control test (ACT) will be used to detect differences in the level of asthma control during treatment. The study aims to show a correlation between improvements of ACT und the level of asthma control which will be reached by the patients.
The aim of the study is to show that most of symptomatic asthma patients can reach 'well controlled asthma' with SFC. We get information about ACT in daily practice and physicians are trained to use the asthma control test as a screening tool and for follow up of asthma management. Correlations are expected between the improvements in ACT, Quality of Life and asthma control according to the Gaining Optimal Asthma controL (GOAL) criteria.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Percentage of well controlled participants as per gaining optimal asthma control (GOAL) criteria after 12 week compared to percentage of participants with asthma control test (ACT) score of 20-25 for Week 9 to Week 12

Timeframe: Week 9 to Week 12

Secondary outcomes:

Change from Baseline in percentage of participants with ACT score of 20-25 at Week 12

Timeframe: Baseline (Visit 3) and Week 12

Change from Baseline in mean ACT score at Visit 6

Timeframe: Baseline (Viait 3) and Week 12

Number of participants with well controlled and totally controlled asthma at Week 12

Timeframe: Week 12

Change from Baseline in quality of life using the asthma quality of life questionnaire (AQLQ)

Timeframe: Baseline (Visit 3) up to Week 12

Correlation of change in AQLQ score and change in ACT score

Timeframe: Week 12

Change from Baseline in Forced expiratory volume (FEV1) to Week 12

Timeframe: Baseline (Visit 3) up to Week 12

Change from Baseline in mean morning percent predicted peak expiratory flow (PEF) at Week 12

Timeframe: Baseline (Visit 3) and Week 12

Change from Baseline in mean 24-hour symptom score at Week 12

Timeframe: Baseline (Visit 3) and Week 12

Change from Baseline in number of additional usage of salbutamol at Week 12

Timeframe: Baseline (Visit 3) and week 12

Percent change from Baseline in number of nights with no nocturnal awakening at Week 12

Timeframe: Baseline (Visit 3) and week 12

Number of participants with emergency visits due to asthma

Timeframe: Up to week 12

Number of participants with adverse events (AE) leading to a change in asthma treatment

Timeframe: Up to Week 12

Assessment of tolerability by number of participants with at least one treatment emergent serious and, non-serious AE

Timeframe: Up to Week 12

Assessment of tolerability by change from baseline of Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Timeframe: Baseline (Visit 3) up to Week 12

Assessment of tolerability by change from baseline of Pulse Rate

Timeframe: Baseline (Visit 3) up to Week 12

Number of Participants with occurrence of (near-) incidents associated with peak flow measurements

Timeframe: Up to Week 12

Interventions:
  • Drug: Salmeterol/Fluticasone 50/250 mcg
  • Drug: Salbutamol 100 mcg
  • Device: DISKUS™ powder inhalers
    • Enrollment:
    221
    Primary completion date:
    2007-14-09
    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)
    May 2006 to September 2007
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Diagnosis of asthma
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Diagnosis of asthma
    • Reversibility >12% after inhalation of 200 µg Salbutamol
    • willingness and ability to complete daily record card on daily basis and to measure morning PEF on daily basis
    • 80% compliance in diary card completion asthma control status: Uncontrolled based on the GOAL criteria Exclusion criteria:
    • Change of asthma medication during the last 4 weeks
    • Asthma exacerbation characterized by use of oral corticoids during the last 3 months Pretreatment with inhaled corticosteroids more than 500 mcg Beclometasondipropionat or equivalent per day or other controller therapy during the last 3 months
    • upper or lower respiratory tract infection during the RUN-IN period moderate or severe asthma exacerbation during the RUN-IN period
    • Non compliance with use of Discus, PEF-meter and incomplete diary card data

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Wuerzburg, Bayern, Germany, 97070
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Hamburg, Hamburg, Germany, 22767
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Muenchen, Bayern, Germany, 80335
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Berlin, Berlin, Germany, 12165
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Kassel, Hessen, Germany, 34117
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Geesthacht, Schleswig-Holstein, Germany, 21502
    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

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2007-14-09
    Actual study completion date
    2007-14-09

    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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