Last updated: 11/04/2018 11:19:38
A Long Term Prospective Follow Up Study For The CATO Study (SAS30018/SER9702)
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Case-Only
Primary completion date:
Not applicable
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
- 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
- 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
Inclusion and exclusion 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)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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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