Bronchial AsthmaPhase 3NCT00449046
Clinical Assessment Of GW815SF Salmeterol/Fluticasone Propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-
A Phase 3 study testing GW815SF Salmeterol/Fluticasone propionate(HFA MDI) in people with Bronchial Asthma, run by GlaxoSmithKline at 3 sites in Japan.
Trial summary
This study evaluates the long-term (24-week) safety and efficacy of GW815SF Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of 25/50mcg) bid in pediatric patients with bronchial asthma. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Bronchial Asthma
- What is being tested?
- GW815SF Salmeterol/Fluticasone propionate(HFA MDI)
- How many people
- 40 participants
- Where
- 3 sitesJapan
- Study dates
- Mar 2007to Nov 2007
- Phase
- Phase 3
- 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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A pediatric patient already diagnosed as having bronchial asthma who meets all of the following criteria is eligible for the study:
- Male or female patients aged ≥5 and ≤14 years. Enrolment of a female patient of childbearing potential is allowed only if she is tested negative in the pregnancy testing at the start of treatment period and if she agrees to undergo pregnancy testing at the protocol-specified timings and to take contraceptive measures without fail during the study period.
- Written informed consent must be obtained from the legally acceptable representative of the subject. Consent of the subject him/herself should also be obtained, wherever possible, after giving an explanation in an as easy to understand as possible manner.
- An outpatient who has been treated with ICS (FP 100-200μg/day or equivalent) for at least 4 weeks prior to Visit 1.
- Is suitable, in the investigator's/subinvestigator's judgment, for treatment with GW815SF HFA MDI 25/50μg (administered as 2 inhalations of 25/50μg) bid.
- Able to use a peak flow meter in a correct manner in the investigator's/subinvestigator's judgment.
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- Able to use MDI in a correct manner (with the assistance of his/her caregiver as necessary) in the investigator's/subinvestigator's judgment.
- Inclusion Criteria for Entry in Treatment Period A subject will be considered eligible for inclusion in the treatment period only if he/she has completed the run-in period and meets the following criterion.
- 1. Has been able, in the investigator's/subinvestigator's judgment, to make entries in the asthma diary and measure PEF, as directed, during the run-in period.
Who cannot join
- A patient who applies any of the following criteria is not eligible for the study:
- Admitted to the hospital due to asthma exacerbation within 8 weeks prior to Visit 1.
- Used systemic steroid within 4 weeks prior to Visit 1.
- Received antibacterials or antivirals for treatment of upper or lower respiratory tract infection within 2 weeks prior to Visit 1.
- Has a safety problem in participation in the study because of a serious, uncontrolled systemic disease including nervous system disorder.
- Has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available.
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- Has or is suspected to have hypersensitivity to the investigational product, rescue medication or any ingredients of them.
- Is pregnant or lactating, may be pregnant, or plans for pregnancy during the study period.
- Has received the last dose in another clinical study within 2 months prior to this study.
- Is not eligible for the study in the investigator's/subinvestigator's judgment.
- A subject who applies to any of the following criteria is not eligible for the study:
- Admitted to the hospital due to asthma exacerbation during the run-in period.
- Had upper or lower respiratory tract infection during the 2 weeks just before Visit 2.
- Used prohibited drugs during the 2 weeks just before Visit 2.
- Is not eligible for the study in the investigator's/subinvestigator's judgment.
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
GSK Clinical Trials Call Center
Funabashi, Chiba, 273
GSK Clinical Trials Call Center
Setagaya, Tokyo, 157
GSK Clinical Trials Call Center
Takasaki, Gunma, 370
About this study
Official title: Clinical Assessment of GW815SF Salmeterol/Fluticasone Propionate (HFA MDI) in Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-
This study evaluates the long-term (24-week) safety and efficacy of GW815SF Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of 25/50mcg) bid in pediatric patients with bronchial asthma.
- Conditions
- Bronchial Asthma
- Being tested
- GW815SF Salmeterol/Fluticasone propionate(HFA MDI)
- Keywords
- salmeterol/fluticasone propionate combination, pediatric bronchial asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW815SF Salmeterol/Fluticasone propionate(HFA MDI)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Most Frequent Adverse Events - On Therapy
Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.
Measured: Baseline to Week 24
Serious Adverse Events (SAEs) - On Therapy
Number of participants considered by the investigator to be related to study medication.
Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)
Measured: Baseline to Week 24
Secondary outcomes (6)
Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24
PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Measured: Baseline and during Weeks 1-24
Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24
Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.
Measured: Baseline and during Weeks 1-24
Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24
The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Measured: Baseline and during Weeks 1-24
Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24
Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
Measured: Baseline and during Weeks 1-24
Number of Participants With Symptom-Free Nights and Days
Measured: Baseline and Week 24
Number of Participants With Rescue Medication-Free Nights and Days
Rescue free means without the use of other medication.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2007
- Study completionNov 2007
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.
- Other trials for Bronchial 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
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
- NCT00449046
- Sponsor's protocol ID
- 110101
- Status last verified
- Apr 2015
- First submitted
- 16 Mar 2007
- Last updated
- 6 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of GW815SF Salmeterol/Fluticasone Propionate (HFA MDI) in Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-
- ClinicalTrials.gov ID
- NCT00449046
- Acronym / sponsor ID
- 110101
- Conditions
- Bronchial Asthma
- Keywords
- salmeterol/fluticasone propionate combination, pediatric bronchial asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 19 Mar 2007 (estimated)
- Results
- Posted 4 Aug 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 evaluates the long-term (24-week) safety and efficacy of GW815SF Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of 25/50mcg) bid in pediatric patients with bronchial asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- A pediatric patient already diagnosed as having bronchial asthma who meets all of the following criteria is eligible for the study:
- Male or female patients aged ≥5 and ≤14 years. Enrolment of a female patient of childbearing potential is allowed only if she is tested negative in the pregnancy testing at the start of treatment period and if she agrees to undergo pregnancy testing at the protocol-specified timings and to take contraceptive measures without fail during the study period.
- Written informed consent must be obtained from the legally acceptable representative of the subject. Consent of the subject him/herself should also be obtained, wherever possible, after giving an explanation in an as easy to understand as possible manner.
- An outpatient who has been treated with ICS (FP 100-200μg/day or equivalent) for at least 4 weeks prior to Visit 1.
- Is suitable, in the investigator's/subinvestigator's judgment, for treatment with GW815SF HFA MDI 25/50μg (administered as 2 inhalations of 25/50μg) bid.
Key exclusion criteria (15 listed)
- Admitted to the hospital due to asthma exacerbation within 8 weeks prior to Visit 1.
- Used systemic steroid within 4 weeks prior to Visit 1.
- Received antibacterials or antivirals for treatment of upper or lower respiratory tract infection within 2 weeks prior to Visit 1.
- Has a safety problem in participation in the study because of a serious, uncontrolled systemic disease including nervous system disorder.
- Has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available.
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 |
|---|---|---|
| GW815SF Salmeterol/Fluticasone propionate(HFA MDI) | Drug | – |
Primary outcome
Most Frequent Adverse Events - On Therapy
Time frame: Baseline to Week 24
Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.
Serious Adverse Events (SAEs) - On Therapy
Time frame: Baseline to Week 24
Number of participants considered by the investigator to be related to study medication. Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)
6 secondary outcomes
Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24
Time frame: Baseline and during Weeks 1-24
Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24
Time frame: Baseline and during Weeks 1-24
Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24
Time frame: Baseline and during Weeks 1-24
Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24
Time frame: Baseline and during Weeks 1-24
Number of Participants With Symptom-Free Nights and Days
Time frame: Baseline and Week 24
Number of Participants With Rescue Medication-Free Nights and Days
Time frame: Baseline and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
3 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 GW815SF Salmeterol/Fluticasone propionate(HFA MDI) in people with Bronchial Asthma, run by GlaxoSmithKline at 3 sites in Japan.
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 9 inclusion and 15 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 6 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. 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?
Yes. Results are posted in the registry (first posted 4 Aug 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?
Most Frequent Adverse Events - On Therapy (time frame: Baseline to Week 24). The study lists 2 primary outcomes in all. 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 6 May 2015.