AsthmaPhase 3NCT00158834
Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications
A Phase 3 study testing Salmeterol/Fluticasone propionate combination product and Fluticasone propionate in people with Asthma, run by GlaxoSmithKline at 16 sites in Netherlands.
Trial summary
This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when… Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Asthma
- What is being tested?
- Salmeterol/Fluticasone propionate combination product and Fluticasone propionate
- How many people
- 200 participants
- Where
- 16 sitesNetherlands
- Study dates
- Nov 1999to not given
- Phase
- Phase 3
- 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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with a documented history of asthma.
- Using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start.
- Must be able to perform reproducible lung function tests.
- Must have a positive RAST or skin prick test.
- During the treatment period, the patient has to be hyperreactive (defined as PD20 methacholine < 150 mcg) and/or have a cumulative symptom score of 14 based on the daily record card filled in during the last 2 weeks of the run-in period.
Who cannot join
- History of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit 1.
- Admitted to hospital due to a respiratory disease 4 weeks prior to visit 1.
- Received oral corticosteroids within 4 weeks prior to visit 1.
- Existence of any disorder that affects growth.
- Clinical or laboratory evidence of a serious systemic disease, or suspected hypersensitivity to corticosteroids, lactose or short/long acting B2-agonists.
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Netherlands16 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, 4818 CK
GSK Investigational Site
Eindhoven, 5623 EJ
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 GD
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, 8011 JW
About this study
Official title: 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)
This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (PD20 methacholine).
- Conditions
- Asthma
- Being tested
- Salmeterol/Fluticasone propionate combination product, Fluticasone propionate
- Keywords
- Children, Asthma, bronchial hyperresponsiveness, symptoms
- 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.
Salmeterol/Fluticasone propionate combination productDrug
Fluticasone propionateDrug
Also called Salmeterol/Fluticasone propionate combination product
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma symptom free days during the last 12 weeks of the treatment period.
Secondary outcomes (1)
Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startNov 1999
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 200 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158834
- Sponsor's protocol ID
- SAS30018
- Other IDs
- SER9702/CATO
- Status last verified
- Oct 2008
- First submitted
- 8 Sep 2005
- Last updated
- 13 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00158834
- Acronym / sponsor ID
- SAS30018
- Conditions
- Asthma
- Keywords
- Children, Asthma, bronchial hyperresponsiveness, symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 1999
- First posted
- 12 Sep 2005 (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.
This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (PD20 methacholine).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children with a documented history of asthma.
- Using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start.
- Must be able to perform reproducible lung function tests.
- Must have a positive RAST or skin prick test.
- During the treatment period, the patient has to be hyperreactive (defined as PD20 methacholine < 150 mcg) and/or have a cumulative symptom score of 14 based on the daily record card filled in during the last 2 weeks of the run-in period.
Key exclusion criteria (5 listed)
- History of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit 1.
- Admitted to hospital due to a respiratory disease 4 weeks prior to visit 1.
- Received oral corticosteroids within 4 weeks prior to visit 1.
- Existence of any disorder that affects growth.
- Clinical or laboratory evidence of a serious systemic disease, or suspected hypersensitivity to corticosteroids, lactose or short/long acting B2-agonists.
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 |
|---|---|---|
| Salmeterol/Fluticasone propionate combination product | Drug | – |
| Fluticasone propionateAlso: Salmeterol/Fluticasone propionate combination product | Drug | – |
Primary outcome
Asthma symptom free days during the last 12 weeks of the treatment period.
1 secondary outcome
Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study.
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 13 Oct 2008.
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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, MD study director
GlaxoSmithKline
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Salmeterol/Fluticasone propionate combination product and Fluticasone propionate in people with Asthma, run by GlaxoSmithKline at 16 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 5 inclusion and 5 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 13 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Asthma symptom free days during the last 12 weeks of the treatment period.. 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 13 Oct 2008.