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

March 15, 2012 updated by: GlaxoSmithKline

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • GSK Investigational Site
      • Almere, Netherlands, 1315 RA
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1105 AZ
        • GSK Investigational Site
      • Amsterdam, Netherlands, 1081 HV
        • GSK Investigational Site
      • Breda, Netherlands, 4819 EV
        • GSK Investigational Site
      • Den Haag, Netherlands, 2566 MJ
        • GSK Investigational Site
      • Groningen, Netherlands, 9713 GZ
        • GSK Investigational Site
      • Hilversum, Netherlands, 1213 VX
        • GSK Investigational Site
      • Leiden, Netherlands, 2333 ZA
        • GSK Investigational Site
      • Maastricht, Netherlands, 6229 HX
        • GSK Investigational Site
      • Rotterdam, Netherlands, 3015 GJ
        • GSK Investigational Site
      • Sittard, Netherlands, 6131 BK
        • GSK Investigational Site
      • Utrecht, Netherlands, 3584 EA
        • GSK Investigational Site
      • Veldhoven, Netherlands, 5504 DB
        • GSK Investigational Site
      • Zwolle, Netherlands, 8025 AB
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Salmeterol/Fluticasone
Previous Salmeterol/Fluticasone treatment
Procedure: Symptom Score
Symptom Score
Procedure: Symptom Score and PD20
Symptom Score and PD20
Fluticasone
Previous Fluticasone propionate treatment
Procedure: Symptom Score
Symptom Score
Procedure: Symptom Score and PD20
Symptom Score and PD20

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of the mean annual in FEV1 (% predicted) between randomisation (CATO visit 2) and the current visit 2 between both treatment arms.
Time Frame: 6 years
6 years

Secondary Outcome Measures

Outcome Measure
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
Time Frame: 6 years
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
Time Frame: 6 years
6 years
Growth rate between randomisation and current visit 2 (expressed as SD-scores)•frequency of asthma exacerbations between randomisation and current visit 2
Time Frame: 6 years
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)
Time Frame: 6 years
6 years
Quality of Life (Juniper questionnaire)
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

February 28, 2007

First Submitted That Met QC Criteria

February 28, 2007

First Posted (Estimate)

March 1, 2007

Study Record Updates

Last Update Posted (Estimate)

March 19, 2012

Last Update Submitted That Met QC Criteria

March 15, 2012

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAS107541

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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