Last updated: 11/04/2018 11:19:38

A Long Term Prospective Follow Up Study For The CATO Study (SAS30018/SER9702)

GSK study ID
SAS107541
See study documents
Clinicaltrials.gov ID
NCT00441675
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 long term follow up study for a comparison of stepwise treatment of asthmatic children with Salmeterol/Fluticasone propionate combination product (SERETIDE®) and/or Fluticasone propionate (FLIXOTIDE (TM)) based on PD20 methacholine and symptoms or based on symptoms only.
Trial description: The CATO population is a very well documented population during two years. During this study patients were treated according to the CATO algorithm, after that patient were treated according to the Dutch national (GINA derived) guidelines up to 6 years of follow-up. The purpose of this prospective follow-up study is to understand the long-term effects of treatment. Therefore the measurements done at baseline (CATO part 1) are repeated after 6 years in this CATO-population (CATO follow-up).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Comparison of the mean annual in FEV1 (% predicted) between randomisation (CATO visit 2) and the current visit 2 between both treatment arms.

Timeframe: 6 years

Secondary outcomes:

Comparison of both treatment arms (BHR strategy versus reference strategy):• Lung function FVC and PEFR measured in the clinic between randomisation ( and current visit 2 expressed as the mean annual change of % predicted

Timeframe: 6 years

• Percentage asthma symptom free days during 6 weeks of this extension study • Bronchial hyperresponsiveness, determined with PD20 methacholine between randomisation and current visit 2

Timeframe: 6 years

Growth rate between randomisation and current visit 2 (expressed as SD-scores)•frequency of asthma exacerbations between randomisation and current visit 2

Timeframe: 6 years

• Height at current visit 1 or at last measurement at which subject has reached their final height.• Cumulative ICS doses between randomisation and current visit 2 (if this can be achieved with sufficient reliability)

Timeframe: 6 years

Quality of Life (Juniper questionnaire)

Timeframe: 6 weeks

Interventions:
  • Procedure/surgery: Symptom Score
  • Procedure/surgery: Symptom Score and PD20
    • Enrollment:
    137
    Primary completion date:
    Not applicable
    Observational study model:
    Case-Only
    Time perspective:
    Other
    Clinical publications:
    Not applicable
    Medical condition
    Asthma
    Product
    fluticasone propionate, salmeterol
    Collaborators
    Not applicable
    Study date(s)
    January 2007 to October 2007
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable+ years
    Accepts healthy volunteers
    No
    • Inclusion criteria:
    • Any subject who has given informed consent to participate in the CATO study, and has met all the criteria required for randomisation into the clinical study may take part in this follow up study
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion criteria:
    • Any subject who has given informed consent to participate in the CATO study, and has met all the criteria required for randomisation into the clinical study may take part in this follow up study
    • Under the age of 18 years Subjects and both parent(s)/guardian(s) who have given written informed consent to participate in the study
    • Subjects from 18 years and older who have given written informed consent to participate in the study Exclusion criteria:
    • Experienced an acute asthma exacerbation requiring emergency room treatment within 4 weeks or hospitalisation within 4 weeks of visit 1
    • Any use of oral/parenteral or depot corticosteroid within 4 weeks of visit 1
    • Subjects who are pregnant (a pregnancy test can be performed at the investigator’s discretion)

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    ZWOLLE, Netherlands, 8025 AB
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    AMSTERDAM, Netherlands, 1081 HV
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    HILVERSUM, Netherlands, 1213 VX
    Status
    Study Complete
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    Location
    GSK Investigational Site
    UTRECHT, Netherlands, 3584 EA
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    MAASTRICHT, Netherlands, 6229 HX
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    ALMERE, Netherlands, 1315 RA
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 15 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
    2007-03-10

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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