Bronchial AsthmaPhase 3NCT00448435
Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
A Phase 3 study testing GW815SF HFA MDI and salmeterol and fluticasone propionate in people with Bronchial Asthma, run by GlaxoSmithKline at 8 sites in Japan.
Trial summary
To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with 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 HFA MDI and salmeterol and fluticasone propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 8 sitesJapan
- Study dates
- Apr 2007to Jan 2008
- 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 1 and if she agrees to undergo pregnancy testing at the protocol-specified timings and to take contraceptive measures without fail.
- Written informed consent must be obtained from a 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 100μg/day or equivalent) for at least 4 weeks prior to Visit 1.
- Able to use a peak flow meter in a correct manner in the investigator's/subinvestigator's judgment.
- Able to use MDI and DPI in a correct manner (with the assistance of his/her caregiver as necessary) in the investigator's/subinvestigator's judgment.
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- Inclusion Criteria for Entry in Treatment Period 1 A subject will be randomized to one of the two treatment groups only if he/she has completed the run-in period and meets all the following criteria.
- Has a mean of morning PEF measurements in the last 7 days of the run-in period (excluding the first day of Treatment Period 1) ≤90% of his/her best PEF measurement .
- Was able to perform entry in the asthma diary and PEF measurements in a correct manner in the investigator's/subinvestigator's judgment.
- Able to use MDI and DPI in a correct manner (with the assistance of his/her caregiver as necessary) in the investigator's/subinvestigator's judgment.
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.
- Enrolment of a subject completing the run-in period into Treatment Period 1 will not be allowed if any of the following applies:
- 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.
- Enrolment of a subject completing the washout period into Treatment Period 2 will not be allowed if any of the following applies:
- Admitted to the hospital due to asthma exacerbation during the washout period.
- Had upper or lower respiratory tract infection during the 2 weeks just before Visit 4.
- Used prohibited drugs during the 2 weeks just before Visit 4.
- Is not eligible for entry in Treatment Period 2 in the investigator's/subinvestigator's judgment.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
GSK Investigational Site
Chiba, 260-0001
GSK Investigational Site
Kanagawa, 245-0018
GSK Investigational Site
Saitama, 360-0018
GSK Investigational Site
Saitama, 360-0812
GSK Investigational Site
Tokyo, 154-0002
GSK Investigational Site
Tokyo, 154-0017
GSK Investigational Site
Tokyo, 158-0083
GSK Investigational Site
Tokyo, 158-0097
About this study
Official title: A Study to Compare GW815SF HFA MDI With Concomitant Treatment With Salmeterol Xinafoate DPI Plus Fluticasone Propionate DPI and to Assess Long-term Safety of GW815SF HFA MDI
To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma.
To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.
- Conditions
- Bronchial Asthma
- Being tested
- GW815SF HFA MDI, salmeterol and fluticasone propionate
- Keywords
- Salmeterol, Fluticasone propionate, 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 HFA MDIDrug
Also called salmeterol/fluticasone propionate combination
salmeterol and fluticasone propionate combination
salmeterol and fluticasone propionateDrug
salmeterol + fluticasone propionate
| Study group | Role | What they receive |
|---|---|---|
| SLM+FP First | Active comparator | SLM(salmeterol) 25mcg + FP(fluticasone propionate) 50mcg twice daily in first intervention period and SFC(salmeterol/fluticasone propionate) 25/50mcg twice daily in second intervention period and (after washout period). Receives: Drug: GW815SF HFA MDI; Drug: salmeterol and fluticasone propionate |
| SFC First | Active comparator | SFC (Salmeterol/Fluticasone propionate combination) 25/50mcg twice daily in first intervention period and SLM (Salmeterol) 25mcg + FP (Fluticasone Propionate) 50mcg twice daily in second intervention period (after washout period). Receives: Drug: GW815SF HFA MDI; Drug: salmeterol and fluticasone propionate |
| SFC | Experimental | SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period). Receives: Drug: GW815SF HFA MDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period [Weeks 1-4/Weeks 7-10]).
Measured: Crossover Period Weeks 1-4, and 7-10
Secondary outcomes (13)
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.
Measured: Crossover Period Weeks 1-4, 7-10
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.
Measured: Crossover Period weeks 1-4, 7-10
Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.
Measured: Crossover Period weeks 1-4, 7-10
Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.
Measured: Crossover Period Weeks 1-4, 7-10
Percentage of Subjects With Symptom-Free Nights & Days
Percentage of subjects with Symptom Free Nights \& Days after 4 weeks of Treatment
Measured: Crossover Period Week 1-4, 7-10
Percentage of Subjects With Rescue Medication-Free Nights and Days
Percentage of subjects with Rescue Medication Free Nights \& Days after 4 weeks of Treatment
Measured: Crossover Period Weeks 1-4, 7-10
Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period
Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30).
Measured: Extension Period Weeks 11-30
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period
Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).
Measured: Extension Period weeks 11-30
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period
Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).
Measured: Extension Period weeks 11-30
Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period
Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).
Measured: Extension Period weeks 11-30
Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period
Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).
Measured: Extension Period weeks 11-30
Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment
Percentage of subjects with Symptom Free Nights \& Days after 20 weeks of Treatment (at week 30).
Measured: Extension Period Weeks 11-30
Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment
Percentage of subjects with Rescue Medication Free Nights \& Days after 20 weeks of Treatment (at week 30).
Measured: Extension Period Weeks 11-30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionJan 2008
- Study completionJan 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.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448435
- Sponsor's protocol ID
- 110099
- Status last verified
- Jun 2010
- First submitted
- 14 Mar 2007
- Last updated
- 8 Jun 2010
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Compare GW815SF HFA MDI With Concomitant Treatment With Salmeterol Xinafoate DPI Plus Fluticasone Propionate DPI and to Assess Long-term Safety of GW815SF HFA MDI
- ClinicalTrials.gov ID
- NCT00448435
- Acronym / sponsor ID
- 110099
- Conditions
- Bronchial Asthma
- Keywords
- Salmeterol, Fluticasone propionate, Salmeterol/Fluticasone propionate combination, Pediatric bronchial asthma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 16 Mar 2007 (estimated)
- Results
- Posted 11 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma.
To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SLM+FP First | Active comparator | Drug: GW815SF HFA MDI, Drug: salmeterol and fluticasone propionateSLM(salmeterol) 25mcg + FP(fluticasone propionate) 50mcg twice daily in first intervention period and SFC(salmeterol/fluticasone propionate) 25/50mcg twice daily in second intervention period and (after washout period). |
| SFC First | Active comparator | Drug: GW815SF HFA MDI, Drug: salmeterol and fluticasone propionateSFC (Salmeterol/Fluticasone propionate combination) 25/50mcg twice daily in first intervention period and SLM (Salmeterol) 25mcg + FP (Fluticasone Propionate) 50mcg twice daily in second intervention period (after washout period). |
| SFC | Experimental | Drug: GW815SF HFA MDISFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period). |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 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 1 and if she agrees to undergo pregnancy testing at the protocol-specified timings and to take contraceptive measures without fail.
- Written informed consent must be obtained from a 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 100μg/day or equivalent) for at least 4 weeks prior to Visit 1.
- Able to use a peak flow meter in a correct manner in the investigator's/subinvestigator's judgment.
Key exclusion criteria (20 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 HFA MDIAlso: salmeterol/fluticasone propionate combinationsalmeterol and fluticasone propionate combination | Drug | SFC, SFC First, SLM+FP First |
| salmeterol and fluticasone propionatesalmeterol + fluticasone propionate | Drug | SFC First, SLM+FP First |
Primary outcome
Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods
Time frame: Crossover Period Weeks 1-4, and 7-10
Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period [Weeks 1-4/Weeks 7-10]).
13 secondary outcomes
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods
Time frame: Crossover Period Weeks 1-4, 7-10
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods
Time frame: Crossover Period weeks 1-4, 7-10
Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods
Time frame: Crossover Period weeks 1-4, 7-10
Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods
Time frame: Crossover Period Weeks 1-4, 7-10
Percentage of Subjects With Symptom-Free Nights & Days
Time frame: Crossover Period Week 1-4, 7-10
Percentage of Subjects With Rescue Medication-Free Nights and Days
Time frame: Crossover Period Weeks 1-4, 7-10
Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period
Time frame: Extension Period Weeks 11-30
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period
Time frame: Extension Period weeks 11-30
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period
Time frame: Extension Period weeks 11-30
Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period
Time frame: Extension Period weeks 11-30
Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period
Time frame: Extension Period weeks 11-30
Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment
Time frame: Extension Period Weeks 11-30
Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment
Time frame: Extension Period Weeks 11-30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2010.
- 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 study director
GlaxoSmithKline
8 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 HFA MDI and salmeterol and fluticasone propionate in people with Bronchial Asthma, run by GlaxoSmithKline at 8 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 10 inclusion and 20 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 8 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 11 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?
Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods (time frame: Crossover Period Weeks 1-4, and 7-10). 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 8 Jun 2010.