A Long Term Prospective Follow Up Study For The CATO Study (SAS30018/SER9702) - Full Text View

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00441675

Purpose

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).

Condition
Asthma

Study Type:	Observational
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®) Based on PD20 Methacholine and Symptoms or Based on Symptoms Only ("Children Asthma Therapy Optimal")

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Fluticasone

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Secondary Outcome Measures:

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
• Quality of life (Juniper) at current visit 2 • Growth rate between randomisation and current visit 2 (expressed as SD-scores)
• 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)

Estimated Enrollment:	180
Study Start Date:	January 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441675

Locations

Netherlands
GSK Clinical Trials Call Center
S GRAVENHAGE, Netherlands, 2566ER
GSK Clinical Trials Call Center
ROTTERDAM, Netherlands, 3015GJ
GSK Clinical Trials Call Center
SITTARD, Netherlands, 6131BK
GSK Clinical Trials Call Center
ZWOLLE, Netherlands, 8011JW
GSK Clinical Trials Call Center
VELDHOVEN, Netherlands, 5504DB
GSK Clinical Trials Call Center
BREDA, Netherlands, 4818CK
GSK Clinical Trials Call Center
GRONINGEN, Netherlands, 9713GZ
GSK Clinical Trials Call Center
HILVERSUM, Netherlands, 1213VX
GSK Clinical Trials Call Center
ALMERE, Netherlands, 1315RA
GSK Clinical Trials Call Center
AMSTERDAM ZUIDOOST, Netherlands, 1105AZ
GSK Clinical Trials Call Center
AMSTERDAM, Netherlands, 1081HV
GSK Clinical Trials Call Center
MAASTRICHT, Netherlands, 6229HX
GSK Clinical Trials Call Center
LEIDEN, Netherlands, 2333ZA
GSK Clinical Trials Call Center
ALKMAAR, Netherlands, 1815JD

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Study ID Numbers:	SAS107541, CATO-follow up
Study First Received:	February 28, 2007
Last Updated:	February 28, 2008
ClinicalTrials.gov Identifier:	NCT00441675 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:

Adolescents
long-term follow-up
Asthma
bronchial hyperresponsiveness
symptoms

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Physiological Effects of Drugs
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Pharmacologic Actions
Lung Diseases, Obstructive
Hypersensitivity

Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 09, 2010