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Completed

NCT Number: NCT00441675

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

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).

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Key information

Conditions

Asthma Bronchial Diseases Bronchial Hyperreactivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Alkmaar, Netherlands

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About this study

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")

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Symptom Score

Procedure

Symptom Score

Symptom Score and PD20

Procedure

Symptom Score and PD20

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. • 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

  3. 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

  4. • 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

  5. Quality of Life (Juniper questionnaire)

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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.

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 1, 2007
Registry last updated
Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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