AsthmaPhase 4NCT00197106
Treatment Of Symptomatic Asthma In Children
A Phase 4 study testing Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg and fluticasone propionate 2 x 100 mcg in people with Asthma, run by GlaxoSmithKline at 18 sites in Netherlands.
Trial summary
This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Asthma
- What is being tested?
- Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg and fluticasone propionate 2 x 100 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 18 sitesNetherlands
- Study dates
- Jun 2005to Oct 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male or female subjects aged 6-12 years (inclusive)
- A female is eligible to enter and participate in the study if she is:
- of non-child-bearing potential; OR of child-bearing potential, but not lactating and pregnant. She declares that it is not probable that she will become pregnant during the study (a pregnancy test can be performed at the investigators discretion)
- Subjects with a documented history of asthma for at least 6 months
- Subjects with a documented history of BHR within 12 months prior to inclusion or BHR on visit 1 (PD20 methacholine < 150 mcg or an equivalence for histamine)
- Subjects who have received BDP, budesonide up to 100-200 mcg bd or fluticasone propionate at a dose of up to 125 mcg bd for at least 4 weeks before the start of the run-in period.
Show all 13Show fewer
- Subjects who are able to use a electronic peakflow /FEV1 meter (PIKO-1)
- Subjects who have a normal length SD score between -2SD and +2SD
- Subjects who are able to use a Diskus inhaler
- Subjects who are able to perform reproducible lung function tests at visit 1 (variation FEV1 < 5% between the two best measurements)
- Subjects and their guardians, who have given written informed consent to participate in the study
- Subjects or their parent/ guardian who are able to understand and complete a DRC. The DRC may be completed by a parent/guardian if the subject is unable to do this him/ herself
- Subjects able to use Ventolin on an 'as required for symptoms' basis
Who cannot join
- Subjects who have been hospitalised for their asthma within 4 weeks of visit 1
- Subjects who had an acute upper respiratory tract infection within 2 weeks or a lower respiratory tract infection within 4 weeks prior to visit 1
- Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to visit 1
- Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
- Subjects with a disorder that affects growth (e.g. Turner's syndrome)
- Subjects who have received any investigational drugs within 4 weeks of visit 1
Show all 10Show fewer
- Subjects with a known or suspected hypersensitivity to inhaled steroids, β2-agonists or lactose
- Subjects who use any medication that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
- Subjects who concurrently participate in another clinical study
- Subjects who have previously been randomised in this trial
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Netherlands18 sites
GSK Investigational Site
Almere Stad, 1315 RA
GSK Investigational Site
Amsterdam, 1105 AZ
GSK Investigational Site
Arnhem, 6815 AD
GSK Investigational Site
Breda, 4819 EV
GSK Investigational Site
Eindhoven, 5623 EJ
GSK Investigational Site
Enschede, 7511JX
GSK Investigational Site
Gouda, 2803 HG
GSK Investigational Site
Groningen, 9713 GZ
GSK Investigational Site
Helmond, 5707 HA
GSK Investigational Site
Hoorn, 1624 NP
GSK Investigational Site
Leeuwarden, 8934 AD
GSK Investigational Site
Maastricht, 6229 HX
GSK Investigational Site
Nijmegen, 6532 SZ
GSK Investigational Site
Sittard, 6131 BK
GSK Investigational Site
The Hague, 2566 MJ
GSK Investigational Site
Utrecht, 3584 CX
GSK Investigational Site
Veldhoven, 5504 DB
GSK Investigational Site
Zwolle, 8025 AB
About this study
Official title: A Multicentre, Randomised, Double-blind, Parallel Group Study to Compare the Efficacy and Safety of Salmeterol/Fluticasone Propionate Combination Product (Seretide®) 50/100 mcg With Fluticasone Propionate (Flixotide® ) 200 mcg, Both Delivered Twice Daily Via the DISKUS Inhaler, in the Treatment of Children Aged 6-12 Years With Symptomatic Asthma
This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.
Read the detailed description
A multicentre, randomised, double blind, parallel group study to compare the efficacy and safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100mcg with Fluticasone propionate (Flixotide®) 200mcg, both delivered twice daily via the DISKUS inhaler, in the treatment of children aged 6-12 years with symptomatic asthma.
- Conditions
- Asthma
- Being tested
- Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg, fluticasone propionate 2 x 100 mcg
- Keywords
- salmeterol/fluticasone combination, Asthma, bronchial hyperresponsiveness, Children, symptom control
- 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 Diskus® inhaler 50/100 mcgDrug
comparator
fluticasone propionate 2 x 100 mcgDrug
Also called Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg
comparator
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg | Active comparator | Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg Receives: Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg |
| fluticasone propionate 2 x 100 mcg | Other | fluticasone propionate 2 x 100 mcg Receives: Drug: fluticasone propionate 2 x 100 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period
Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary.
Measured: Last 10 weeks of the treatment period (Weeks 16-26)
Secondary outcomes (14)
Percentage of Symptom-free Days During the Entire Treatment Period
Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary
Measured: Baseline to Week 26
Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26
Change from Baseline was calculated as the Week 26 value minus the Baseline value. The percentage predicted FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath and is corrected for the FEV1 value corresponding with the same age.
Measured: Baseline and Week 26
Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26
Change from Baseline was calculated as the Week 26 value minus the Baseline value. Forced vital capacity is defined as the maximum volume of air that can be forcibly expired from the lungs and is calculated by use of spirometry. The spirometry test is performed by using a device called a spirometer, which measures the amount of air one can blow out maximally. Generally, the participant is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible. The test is normally repeated three times to ensure reproducibility.
Measured: Baseline and Week 26
Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26
Change from Baseline was calculated as the Week 26 value minus the Baseline value. MEF 50 is defined as maximum expiratory flow rate at 50% of vital capacity. Vital capacity is the maximum amount of air that a person can expel from the lungs after first filling the lungs to their maximum extent. Midexpiratory flow was calculated by use of spirometry. The test is normally repeated at least three times in order to ensure reproducibility.
Measured: Baseline and Week 26
Geometric Means of Nitric Oxide (NO) at Week 26
Geometric mean values of NO at week 26 were compared using ANCOVA with adjustment for baseline value of NO, age, gender and center. Analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables.
Measured: Baseline and Week 26
Percent Change From Baseline in RINT Measurements at Week 26
Change from Baseline was calculated as the Week 26 value minus the Baseline value. Interrupter respiratory resistance (RINT) measurements were calculated by a combined analysis for relation between change from baseline and occurrence of the endpoint. RINT is a technique that is used for evaluating lung function in poorly collaborating patients (e.g., small children). The measurement is performed during tidal breathing (normal breathing) instead of during maximal expiration, as is done by a spirometry test.
Measured: Baseline and Week 26
Number of Asthma Exacerbations Per Treatment Group at Week 26
An exacerbation is defined as a worsening of the asthma complaints (commonly referred to as an asthma attack) and is reported by the participant experiencing the event. An exacerbation was verified by the use of asthma rescue medication.
Measured: Week 26
Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26
PD20 was calculated by using increasing dosages of methacholine. The dosage that caused a 20% fall in FEV1 was used for analysis. The presented data are ratios (month 6/Baseline) of geometric mean PD20 values.
Measured: Baseline and Week 26
Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres
Bronchial hyperresponsiveness with PD20 AMP in selected centres was not analyzed, as this outcome measure was removed in a protocol amendment.
Measured: 26 weeks
Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)
Daily FEV1 and PEF via the electronic pea kflow/FEV1 meter (PIKO-1) was not assessed because data from the peak flow meters could not be used for analysis.
Measured: 26 weeks
Frequency of Asthma Exacerbations (Discriminated on Severity)
The frequency of asthma exacerbations (discriminated on severity) was not analyzed because of the low overall frequency.
Measured: 26 weeks
Cumulative Number of Symptom-free Weeks Until the End of Treatment
This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.
Measured: 26 weeks
Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks'
This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.
Measured: 26 weeks
Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week'
This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 176 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
- NCT00197106
- Sponsor's protocol ID
- SAM101667
- Status last verified
- Apr 2012
- First submitted
- 9 Sep 2005
- Last updated
- 14 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Vaessen-Verberne AA, van den Berg NJ, van Nierop JC, Brackel HJ, Gerrits GP, Hop WC, Duiverman EJ; COMBO Study Group. Combination therapy salmeterol/fluticasone versus doubling dose of fluticasone in children with asthma. Am J Respir Crit Care Med. 2010 Nov 15;182(10):1221-7. doi: 10.1164/rccm.201002-0193OC. Epub 2010 Jul 9.
PubMed 20622031
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Parallel Group Study to Compare the Efficacy and Safety of Salmeterol/Fluticasone Propionate Combination Product (Seretide®) 50/100 mcg With Fluticasone Propionate (Flixotide® ) 200 mcg, Both Delivered Twice Daily Via the DISKUS Inhaler, in the Treatment of Children Aged 6-12 Years With Symptomatic Asthma
- ClinicalTrials.gov ID
- NCT00197106
- Acronym / sponsor ID
- SAM101667
- Conditions
- Asthma
- Keywords
- salmeterol/fluticasone combination, Asthma, bronchial hyperresponsiveness, Children, symptom control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Posted 14 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.
Detailed description
A multicentre, randomised, double blind, parallel group study to compare the efficacy and safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100mcg with Fluticasone propionate (Flixotide®) 200mcg, both delivered twice daily via the DISKUS inhaler, in the treatment of children aged 6-12 years with symptomatic asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg | Active comparator | Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcgSalmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg |
| fluticasone propionate 2 x 100 mcg | Other | Drug: fluticasone propionate 2 x 100 mcgfluticasone propionate 2 x 100 mcg |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Male or female subjects aged 6-12 years (inclusive)
- A female is eligible to enter and participate in the study if she is:
- of non-child-bearing potential; OR of child-bearing potential, but not lactating and pregnant. She declares that it is not probable that she will become pregnant during the study (a pregnancy test can be performed at the investigators discretion)
- Subjects with a documented history of asthma for at least 6 months
- Subjects with a documented history of BHR within 12 months prior to inclusion or BHR on visit 1 (PD20 methacholine < 150 mcg or an equivalence for histamine)
Key exclusion criteria (10 listed)
- Subjects who have been hospitalised for their asthma within 4 weeks of visit 1
- Subjects who had an acute upper respiratory tract infection within 2 weeks or a lower respiratory tract infection within 4 weeks prior to visit 1
- Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to visit 1
- Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
- Subjects with a disorder that affects growth (e.g. Turner's syndrome)
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 Diskus® inhaler 50/100 mcgcomparator | Drug | Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg |
| fluticasone propionate 2 x 100 mcgAlso: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcgcomparator | Drug | fluticasone propionate 2 x 100 mcg |
Primary outcome
Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period
Time frame: Last 10 weeks of the treatment period (Weeks 16-26)
Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant's diary.
14 secondary outcomes
Percentage of Symptom-free Days During the Entire Treatment Period
Time frame: Baseline to Week 26
Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26
Time frame: Baseline and Week 26
Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26
Time frame: Baseline and Week 26
Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26
Time frame: Baseline and Week 26
Geometric Means of Nitric Oxide (NO) at Week 26
Time frame: Baseline and Week 26
Percent Change From Baseline in RINT Measurements at Week 26
Time frame: Baseline and Week 26
Number of Asthma Exacerbations Per Treatment Group at Week 26
Time frame: Week 26
Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26
Time frame: Baseline and Week 26
Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres
Time frame: 26 weeks
Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)
Time frame: 26 weeks
Frequency of Asthma Exacerbations (Discriminated on Severity)
Time frame: 26 weeks
Cumulative Number of Symptom-free Weeks Until the End of Treatment
Time frame: 26 weeks
Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks'
Time frame: 26 weeks
Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week'
Time frame: 26 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20622031Vaessen-Verberne AA, van den Berg NJ, van Nierop JC, Brackel HJ, Gerrits GP, Hop WC, Duiverman EJ; COMBO Study Group. Combination therapy salmeterol/fluticasone versus doubling dose of fluticasone in children with asthma. Am J Respir Crit Care Med. 2010 Nov 15;182(10):1221-7. doi: 10.1164/rccm.201002-0193OC. Epub 2010 Jul 9.
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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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg and fluticasone propionate 2 x 100 mcg in people with Asthma, run by GlaxoSmithKline at 18 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 13 inclusion and 10 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 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period (time frame: Last 10 weeks of the treatment period (Weeks 16-26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00197106, which also lists 1 linked publication.
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 14 Mar 2017.