A Long Term Prospective Follow Up Study For The CATO Study (SAS30018/SER9702)
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Symptom Score (Procedure); Symptom Score and PD20 (Procedure)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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).
Clinical Details
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.
Study design: Observational Model: Case-Only
Primary outcome: Comparison of the mean annual in FEV1 (% predicted) between randomisation (CATO visit 2) and the current visit 2 between both treatment arms.
Secondary outcome: 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• Percentage asthma symptom free days during 6 weeks of this extension study • Bronchial hyperresponsiveness, determined with PD20 methacholine between randomisation and current visit 2 Growth rate between randomisation and current visit 2 (expressed as SD-scores)•frequency of asthma exacerbations between randomisation and current visit 2 • 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) Quality of Life (Juniper questionnaire)
Detailed description:
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®) based on PD20 methacholine and symptoms or based on symptoms only
("Children Asthma Therapy Optimal")
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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)
Locations and Contacts
GSK Investigational Site, Alkmaar 1815 JD, Netherlands
GSK Investigational Site, Almere 1315 RA, Netherlands
GSK Investigational Site, Amsterdam 1081 HV, Netherlands
GSK Investigational Site, Amsterdam 1105 AZ, Netherlands
GSK Investigational Site, Breda 4819 EV, Netherlands
GSK Investigational Site, Den Haag 2566 MJ, Netherlands
GSK Investigational Site, Groningen 9713 GZ, Netherlands
GSK Investigational Site, Hilversum 1213 VX, Netherlands
GSK Investigational Site, Leiden 2333 ZA, Netherlands
GSK Investigational Site, Maastricht 6229 HX, Netherlands
GSK Investigational Site, Rotterdam 3015 GJ, Netherlands
GSK Investigational Site, Sittard 6131 BK, Netherlands
GSK Investigational Site, Utrecht 3584 EA, Netherlands
GSK Investigational Site, Veldhoven 5504 DB, Netherlands
GSK Investigational Site, Zwolle 8025 AB, Netherlands
Additional Information
Starting date: January 2007
Last updated: March 15, 2012
|