AsthmaNCT00441675
A Long Term Prospective Follow Up Study For The CATO Study (SAS30018/SER9702)
An observational study of Asthma, run by GlaxoSmithKline at 15 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma
- What is being tested?
- Symptom Score and Symptom Score and PD20
- Type of treatment
- Surgery or procedure
- How many people
- 137 participants
- Where
- 15 sitesNetherlands
- Study dates
- Jan 2007to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Netherlands15 sites
GSK Investigational Site
Alkmaar, 1815 JD
GSK Investigational Site
Almere Stad, 1315 RA
GSK Investigational Site
Amsterdam, 1081 HV
GSK Investigational Site
Amsterdam, 1105 AZ
GSK Investigational Site
Breda, 4819 EV
GSK Investigational Site
Groningen, 9713 GZ
GSK Investigational Site
Hilversum, 1213 VX
GSK Investigational Site
Leiden, 2333 ZA
GSK Investigational Site
Maastricht, 6229 HX
GSK Investigational Site
Rotterdam, 3015 GJ
GSK Investigational Site
Sittard, 6131 BK
GSK Investigational Site
The Hague, 2566 MJ
GSK Investigational Site
Utrecht, 3584 EA
GSK Investigational Site
Veldhoven, 5504 DB
GSK Investigational Site
Zwolle, 8025 AB
About this study
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.
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).
Read the 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")
- Conditions
- Asthma
- Being tested
- Symptom Score, Symptom Score and PD20
- Keywords
- Adolescents, Asthma, long-term follow-up, symptoms, bronchial hyperresponsiveness
- Medical subject headings
- Asthma, Bronchial Hyperreactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptom ScoreProcedure or surgery
Symptom Score
Symptom Score and PD20Procedure or surgery
Symptom Score and PD20
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol/Fluticasone | Previous Salmeterol/Fluticasone treatment Receives: Procedure: Symptom Score; Procedure: Symptom Score and PD20 | |
| Fluticasone | Previous Fluticasone propionate treatment Receives: Procedure: Symptom Score; Procedure: Symptom Score and PD20 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the mean annual in FEV1 (% predicted) between randomisation (CATO visit 2) and the current visit 2 between both treatment arms.
Measured: 6 years
Secondary outcomes (5)
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
Measured: 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
Measured: 6 years
Growth rate between randomisation and current visit 2 (expressed as SD-scores)•frequency of asthma exacerbations between randomisation and current visit 2
Measured: 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)
Measured: 6 years
Quality of Life (Juniper questionnaire)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study startJan 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00441675
- Sponsor's protocol ID
- SAS107541
- Status last verified
- Jun 2011
- First submitted
- 28 Feb 2007
- Last updated
- 19 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00441675
- Acronym / sponsor ID
- SAS107541
- Conditions
- Asthma
- Keywords
- Adolescents, Asthma, long-term follow-up, symptoms, bronchial hyperresponsiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case only
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salmeterol/Fluticasone | – | Procedure: Symptom Score, Procedure: Symptom Score and PD20Previous Salmeterol/Fluticasone treatment |
| Fluticasone | – | Procedure: Symptom Score, Procedure: Symptom Score and PD20Previous Fluticasone propionate treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptom ScoreSymptom Score | Procedure or surgery | Fluticasone, Salmeterol/Fluticasone |
| Symptom Score and PD20Symptom Score and PD20 | Procedure or surgery | Fluticasone, Salmeterol/Fluticasone |
Primary outcome
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
5 secondary outcomes
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
• 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
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
• 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
Quality of Life (Juniper questionnaire)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by GlaxoSmithKline at 15 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.