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

Study Overview
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Brief Summary
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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).

Detailed Description
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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)

Official Title
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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.

Conditions
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Asthma

Intervention / Treatment
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* Procedure: Symptom Score
* Procedure: Symptom Score and PD20


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Salmeterol/Fluticasone<br>Previous Salmeterol/Fluticasone treatment | Procedure: Symptom Score<br>* Symptom Score<br>Procedure: Symptom Score and PD20<br>* Symptom Score and PD20<br>|
| Fluticasone<br>Previous Fluticasone propionate treatment | Procedure: Symptom Score<br>* Symptom Score<br>Procedure: Symptom Score and PD20<br>* Symptom Score and PD20<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescents, Asthma, long-term follow-up, symptoms, bronchial hyperresponsiveness