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

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Asthma

Treatments

Procedure: Symptom Score and PD20

Procedure: Symptom Score

Study type

Observational

Funder types

Industry

Identifiers

NCT00441675

SAS107541

Details and patient eligibility

About

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).

Full 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")

Enrollment

137 patients

Sex

All

Volunteers

No Healthy Volunteers

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)