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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).
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")
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salmeterol/Fluticasone | Previous Salmeterol/Fluticasone treatment |
| |
| Fluticasone | Previous Fluticasone propionate treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symptom Score | Procedure | Symptom Score |
| |
| 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 |
| 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 |
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Inclusion criteria:
Exclusion criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Alkmaar | 1815 JD | Netherlands | |||
| GSK Investigational Site |
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| Symptom Score and PD20 |
| Procedure |
Symptom Score and PD20 |
|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D016535 | Bronchial Hyperreactivity |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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