A Long Term Prospective Follow Up Study For The CATO Study (SAS30018/SER9702)
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.
1 other identifier
observational
137
1 country
15
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2007
Shorter than P25 for all trials
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMarch 19, 2012
June 1, 2011
9 months
February 28, 2007
March 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of the mean annual in FEV1 (% predicted) between randomisation (CATO visit 2) and the current visit 2 between both treatment arms.
6 years
Secondary Outcomes (5)
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
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
6 years
Growth rate between randomisation and current visit 2 (expressed as SD-scores)•frequency of asthma exacerbations between randomisation and current visit 2
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)
6 years
Quality of Life (Juniper questionnaire)
6 weeks
Study Arms (2)
Salmeterol/Fluticasone
Previous Salmeterol/Fluticasone treatment
Fluticasone
Previous Fluticasone propionate treatment
Interventions
Eligibility Criteria
All patients randomized in the CATO study (SAS30018) (total of 210) were asked to participate in the follow up study. Any subject who gave informed consent to participate in the CATO study, and met all the criteria required for randomisation into the clinical study took part in this follow up study.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (15)
GSK Investigational Site
Alkmaar, 1815 JD, Netherlands
GSK Investigational Site
Almere Stad, 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
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
The Hague, 2566 MJ, Netherlands
GSK Investigational Site
Utrecht, 3584 EA, Netherlands
GSK Investigational Site
Veldhoven, 5504 DB, Netherlands
GSK Investigational Site
Zwolle, 8025 AB, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2007
First Posted
March 1, 2007
Study Start
January 1, 2007
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
March 19, 2012
Record last verified: 2011-06