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	Intervention
Asthma	Procedure: Symptom Score Procedure: Symptom Score and PD20

Study Type:	Observational
Study Design:	Observational Model: Case-Only
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.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

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 [ Time Frame: 6 years ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
• 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 ] [ Designated as safety issue: No ]
Quality of Life (Juniper questionnaire) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	137
Study Start Date:	January 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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 Investigational Site
Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Almere, Netherlands, 1315 RA
GSK Investigational Site
Amsterdam, Netherlands, 1081 HV
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
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

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT00441675 History of Changes
Other Study ID Numbers:	SAS107541
Study First Received:	February 28, 2007
Last Updated:	June 16, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:

Adolescents
Asthma
long-term follow-up
bronchial hyperresponsiveness
symptoms

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on February 09, 2012