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

Asthma Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441675
• Other study ID #: SAS107541
• Status: Completed
• Phase: N/A
• First received: February 28, 2007
• Last updated: March 15, 2012
• Start date: January 2007
• Est. completion date: October 2007

Study information

• Verified date: June 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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).

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")

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Asthma

Intervention

Procedure:
• Symptom Score
Symptom Score
• Symptom Score and PD20
Symptom Score and PD20

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Alkmaar
Netherlands	GSK Investigational Site	Almere
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Breda
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Groningen
Netherlands	GSK Investigational Site	Hilversum
Netherlands	GSK Investigational Site	Leiden
Netherlands	GSK Investigational Site	Maastricht
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Sittard
Netherlands	GSK Investigational Site	Utrecht
Netherlands	GSK Investigational Site	Veldhoven
Netherlands	GSK Investigational Site	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the mean annual in FEV1 (% predicted) between randomisation (CATO visit 2) and the current visit 2 between both treatment arms.		6 years	No
Secondary	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	No
Secondary	• 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	No
Secondary	Growth rate between randomisation and current visit 2 (expressed as SD-scores)•frequency of asthma exacerbations between randomisation and current visit 2		6 years	No
Secondary	• 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	No
Secondary	Quality of Life (Juniper questionnaire)		6 weeks	No