AsthmaPhase 3NCT00328718
Pediatric ADVAIR DISKUS Versus Oral Montelukast Chewable Tablets
A Phase 3 study testing montelukast (5mg QD) and Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) in people with Asthma, run by GlaxoSmithKline at 26 sites in 7 countries.
Trial summary
This study is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment [Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5… Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Asthma
- What is being tested?
- montelukast (5mg QD) and Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)
- How many people
- 526 participants
- Where
- 26 sitesin 7 countries
- Study dates
- Oct 2005to Apr 2007
- 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of asthma for at least 6 months (per American Thoracic Society [ATS] definition).
- Best forced expiratory volume in one second (FEV1) between 55% and 80% of predicted normal.
- More than or 12% FEV1 reversibility following inhalation of salbutamol.
- Must also be symptomatic on short-acting beta-agonists.
- Must not have used inhaled corticosteroids over the previous month or LTRAs (Leukotriene antagonists)over the previous 2 weeks.
Who cannot join
- Hospital admission for asthma within 3 months prior to Visit 1.
- Sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within two weeks immediately preceding Screening Visit 1.
- Oral or parenteral steroid therapy in the last 12 weeks, or more than 3 courses in the last 6 months.
Trial locations and contacts
26 sites in 7 countries.
26 sites in 7 countries
Mexico7 sites
GSK Investigational Site
Chihuahua City, Chihuahua, 31020
GSK Investigational Site
Guadalajara, Jalisco, 44340
GSK Investigational Site
México, 04530
GSK Investigational Site
México, 6720
GSK Investigational Site
Mexico City, 03020
GSK Investigational Site
Mexico City, 14080
GSK Investigational Site
Monterrey, Nuevo León, 64460
Turkey (Türkiye)7 sites
GSK Investigational Site
Adana, 1330
GSK Investigational Site
Ankara, 6100
GSK Investigational Site
Antalya, 7070
GSK Investigational Site
Bursa, 16059
GSK Investigational Site
Istanbul, 34303
GSK Investigational Site
Istanbul, 34668
GSK Investigational Site
Izmir, 35100
Argentina3 sites
GSK Investigational Site
Buenos Aires, C1121ABE
GSK Investigational Site
Capital Federal-Buenos Aires, C1424BSF
GSK Investigational Site
Santa Fe, Santa Fe Province, 3000
Colombia3 sites
GSK Investigational Site
Bogotá, 11001000
GSK Investigational Site
Cali, 76001000
GSK Investigational Site
Medellín, 05001000
Venezuela3 sites
GSK Investigational Site
Caracas, 1010
GSK Investigational Site
Caracas, 1060
GSK Investigational Site
Caracas, 1080
Peru2 sites
GSK Investigational Site
Lima, Lima Province, Lima 1
GSK Investigational Site
Lima, Lima Province, Lima 27
About this study
Official title: Randomised, Double-blind, Double-dummy, Parallel-group, Comparative Study of Salmeterol/FP 50/100mcg bd Inhalation Powder Via Diskus With Oral Montelukast (5mg QD) Chewable Tablets in Children 6-14 Years
This study is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment [Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)] on lung function, asthma control, Health Outcomes including the child's quality of life as measured by Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver's quality of life as measured by Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) at selected centers where a valid translation is available.
Read the detailed description
Pediatric Asthma Clinical Effectiveness study (PEACE). A Randomized, Double-Blind, Double Dummy, Parallel Group comparative clinical study of Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) via DISKUS† with Oral montelukast (5mg QD) Chewable Tablets in Children 6-14 years of Age with Persistent Asthma
- Conditions
- Asthma
- Being tested
- montelukast (5mg QD), Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)
- Keywords
- Persistent Asthma, pediatric asthmatic, asthma control
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
montelukast (5mg QD)Drug
Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)Drug
Also called montelukast (5mg QD)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.
Secondary outcomes (1)
Changes from baseline to endpoint of:morning pre-dose FEV1 (Forced expiratory volume) symptom free 24 hour-periods rescue medication-free 24 hour-periods mean evening PEFR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startOct 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 526 participants
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
- NCT00328718
- Sponsor's protocol ID
- SAM103848
- Status last verified
- Jan 2017
- First submitted
- 19 May 2006
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Maspero J, Guerra F, Cuevas F, Gutierrez JP, Soto-Ramos M, Anderton S, Mechali D, Chan R, Pedersen S. Efficacy and tolerability of salmeterol/fluticasone propionate versus montelukast in childhood asthma: A prospective, randomized, double-blind, double-dummy, parallel-group study. Clin Ther. 2008 Aug;30(8):1492-504. doi: 10.1016/j.clinthera.2008.07.018.
PubMed 18803991
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Double-dummy, Parallel-group, Comparative Study of Salmeterol/FP 50/100mcg bd Inhalation Powder Via Diskus With Oral Montelukast (5mg QD) Chewable Tablets in Children 6-14 Years
- ClinicalTrials.gov ID
- NCT00328718
- Acronym / sponsor ID
- SAM103848
- Conditions
- Asthma
- Keywords
- Persistent Asthma, pediatric asthmatic, asthma control
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 526 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2005 (actual)
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 22 May 2006 (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 is being conducted to demonstrate the superior clinical effectiveness of Salmeterol/Fluticasone Propionate compared to montelukast in the management of persistent asthma in children aged 6-14 years, and to assess the effect of each treatment [Salmeterol/Fluticasone Propionate (50/100 mcg) and montelukast (5 mg)] on lung function, asthma control, Health Outcomes including the child's quality of life as measured by Paediatric Asthma Quality of Life Questionnaire (PAQLQ) and the caregiver's quality of life as measured by Paediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ) at selected centers where a valid translation is available.
Detailed description
Pediatric Asthma Clinical Effectiveness study (PEACE). A Randomized, Double-Blind, Double Dummy, Parallel Group comparative clinical study of Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) via DISKUS† with Oral montelukast (5mg QD) Chewable Tablets in Children 6-14 years of Age with Persistent Asthma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis of asthma for at least 6 months (per American Thoracic Society [ATS] definition).
- Best forced expiratory volume in one second (FEV1) between 55% and 80% of predicted normal.
- More than or 12% FEV1 reversibility following inhalation of salbutamol.
- Must also be symptomatic on short-acting beta-agonists.
- Must not have used inhaled corticosteroids over the previous month or LTRAs (Leukotriene antagonists)over the previous 2 weeks.
Key exclusion criteria (3 listed)
- Hospital admission for asthma within 3 months prior to Visit 1.
- Sinus, middle ear, oropharyngeal, upper or lower respiratory tract infections within two weeks immediately preceding Screening Visit 1.
- Oral or parenteral steroid therapy in the last 12 weeks, or more than 3 courses in the last 6 months.
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 |
|---|---|---|
| montelukast (5mg QD) | Drug | – |
| Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID)Also: montelukast (5mg QD) | Drug | – |
Primary outcome
Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.
1 secondary outcome
Changes from baseline to endpoint of:morning pre-dose FEV1 (Forced expiratory volume) symptom free 24 hour-periods rescue medication-free 24 hour-periods mean evening PEFR
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 20 Jan 2017.
- Background: PubMed 18803991Maspero J, Guerra F, Cuevas F, Gutierrez JP, Soto-Ramos M, Anderton S, Mechali D, Chan R, Pedersen S. Efficacy and tolerability of salmeterol/fluticasone propionate versus montelukast in childhood asthma: A prospective, randomized, double-blind, double-dummy, parallel-group study. Clin Ther. 2008 Aug;30(8):1492-504. doi: 10.1016/j.clinthera.2008.07.018.
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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
26 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing montelukast (5mg QD) and Salmeterol/Fluticasone propionate Inhalation Powder (50/100mcg BID) in people with Asthma, run by GlaxoSmithKline at 26 sites in 7 countries.
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 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 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Mexico, Turkey (Türkiye), Argentina, Colombia, Venezuela and 2 more countries. 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?
Change from baseline in mean morning PEFR (Peak Expiratory Flow Rate) at endpoint.. 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 NCT00328718, 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 20 Jan 2017.