DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: Symptom Score (Procedure); Symptom Score and PD20 (Procedure)

Phase: N/A

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

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).

Clinical Details

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.

Study design: Observational Model: Case-Only

Primary outcome: Comparison of the mean annual in FEV1 (% predicted) between randomisation (CATO visit 2) and the current visit 2 between both treatment arms.

Secondary outcome:

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

• Percentage asthma symptom free days during 6 weeks of this extension study • Bronchial hyperresponsiveness, determined with PD20 methacholine between randomisation and current visit 2

Growth rate between randomisation and current visit 2 (expressed as SD-scores)•frequency of asthma exacerbations between randomisation and current visit 2

• 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)

Quality of Life (Juniper questionnaire)

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")

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

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)

Locations and Contacts

GSK Investigational Site, Alkmaar 1815 JD, Netherlands

GSK Investigational Site, Almere 1315 RA, Netherlands

GSK Investigational Site, Amsterdam 1081 HV, Netherlands

GSK Investigational Site, Amsterdam 1105 AZ, Netherlands

GSK Investigational Site, Breda 4819 EV, Netherlands

GSK Investigational Site, Den Haag 2566 MJ, Netherlands

GSK Investigational Site, Groningen 9713 GZ, Netherlands

GSK Investigational Site, Hilversum 1213 VX, Netherlands

GSK Investigational Site, Leiden 2333 ZA, Netherlands

GSK Investigational Site, Maastricht 6229 HX, Netherlands

GSK Investigational Site, Rotterdam 3015 GJ, Netherlands

GSK Investigational Site, Sittard 6131 BK, Netherlands

GSK Investigational Site, Utrecht 3584 EA, Netherlands

GSK Investigational Site, Veldhoven 5504 DB, Netherlands

GSK Investigational Site, Zwolle 8025 AB, Netherlands

Additional Information

Starting date: January 2007
Last updated: March 15, 2012

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017