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

NCT ID: NCT00441675

Last Updated: 2012-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

137 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-01-31

Study Completion Date

2007-10-31

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).

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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")

Conditions

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Asthma

Study Design

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Observational Model Type

CASE_ONLY

Study Groups

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Salmeterol/Fluticasone

Previous Salmeterol/Fluticasone treatment

Symptom Score

Intervention Type PROCEDURE

Symptom Score

Symptom Score and PD20

Intervention Type PROCEDURE

Symptom Score and PD20

Fluticasone

Previous Fluticasone propionate treatment

Symptom Score

Intervention Type PROCEDURE

Symptom Score

Symptom Score and PD20

Intervention Type PROCEDURE

Symptom Score and PD20

Interventions

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Symptom Score

Symptom Score

Intervention Type PROCEDURE

Symptom Score and PD20

Symptom Score and PD20

Intervention Type PROCEDURE

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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Alkmaar, , Netherlands

Site Status

GSK Investigational Site

Almere Stad, , Netherlands

Site Status

GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

Breda, , Netherlands

Site Status

GSK Investigational Site

Groningen, , Netherlands

Site Status

GSK Investigational Site

Hilversum, , Netherlands

Site Status

GSK Investigational Site

Leiden, , Netherlands

Site Status

GSK Investigational Site

Maastricht, , Netherlands

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

GSK Investigational Site

Sittard, , Netherlands

Site Status

GSK Investigational Site

The Hague, , Netherlands

Site Status

GSK Investigational Site

Utrecht, , Netherlands

Site Status

GSK Investigational Site

Veldhoven, , Netherlands

Site Status

GSK Investigational Site

Zwolle, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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SAS107541

Identifier Type: -

Identifier Source: org_study_id

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