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

Completed

• Conditions: Asthma
• Interventions: Procedure: Symptom Score; Procedure: Symptom Score and PD20

• Registration Number: NCT00441675
• Lead Sponsor: GlaxoSmithKline

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).

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")

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-02-28
• Study First Submitted QC: 2007-02-28
• Study First Posted: 2007-03-01
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2011-06
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Salmeterol/Fluticasone	Symptom Score	Previous Salmeterol/Fluticasone treatment
Salmeterol/Fluticasone	Symptom Score and PD20	Previous Salmeterol/Fluticasone treatment
Fluticasone	Symptom Score	Previous Fluticasone propionate treatment
Fluticasone	Symptom Score and PD20	Previous Fluticasone propionate treatment

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

GSK Investigational Site; 🇳🇱 Zwolle, Netherlands