Last updated: 11/03/2018 10:53:25
Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Adjusted Mean Change from Baseline in Morning PEF (Peak Expiratory Flow) during the 4-week Treatment Periods
Timeframe: Crossover Period Weeks 1-4, and 7-10
Secondary outcomes:
Adjusted Mean Change from Baseline in Percent Predicted Morning PEF(%) during the 4-week Treatment Periods
Timeframe: Crossover Period Weeks 1-4, 7-10
Adjusted Mean Change from Baseline in Percent Personal Best Morning PEF(%) during the 4-week Treatment Periods
Timeframe: Crossover Period weeks 1-4, 7-10
Adjusted Mean Change from Baseline in Evening PEF during the 4-week Treatment Periods
Timeframe: Crossover Period weeks 1-4, 7-10
Adjusted Mean Change from Baseline of Circadian Variation in Morning PEF(%) during the 4-week Treatment Periods
Timeframe: Crossover Period Weeks 1-4, 7-10
Percentage of Subjects with Symptom-Free Nights & Days
Timeframe: Crossover Period Week 1-4, 7-10
Percentage of Subjects with Rescue Medication-Free Nights and Days
Timeframe: Crossover Period Weeks 1-4, 7-10
Adjusted Mean Change from Baseline in Morning PEF during the 20-week Extension Treatment Period
Timeframe: Extension Period Weeks 11-30
Adjusted Mean Change from Baseline in Percent Predicted Morning PEF(%) during the 20-Week Extension Treatment Period
Timeframe: Extension Period weeks 11-30
Adjusted Mean Change from Baseline in Percent Personal Best Morning PEF(%) during the 20-week Extension Treatment Period
Timeframe: Extension Period weeks 11-30
Adjusted Mean Change from Baseline in Evening PEF during the 20-week Extension Treatment Period
Timeframe: Extension Period weeks 11-30
Adjusted Mean Change from Baseline of Circadian Variation in PEF(%) during the 20-Week Extension Treatment Period
Timeframe: Extension Period weeks 11-30
Percentage of Subjects with Symptom-Free Nights & Days after 20 Weeks of Treatment
Timeframe: Extension Period Weeks 11-30
Percentage of Subjects with Rescue Medication-Free Nights & Days after 20 Weeks of Treatment
Timeframe: Extension Period Weeks 11-30
Interventions:
Enrollment:
51
Primary completion date:
2008-19-01
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Bronchial Asthma
Product
fluticasone propionate, salmeterol
Collaborators
Not applicable
Study date(s)
April 2007 to January 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
5 - 14 years
Accepts healthy volunteers
No
- Inclusion criteria:
- Inclusion Criteria for Entry in Run-in Period
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion criteria:
- Inclusion Criteria for Entry in Run-in Period 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. 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. 1. 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 . 2. Was able to perform entry in the asthma diary and PEF measurements in a correct manner in the investigator's/subinvestigator's judgment. 3. 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. Exclusion criteria:
- Exclusion Criteria for Entry in Run-in Period 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.
- 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. Exclusion Criteria for Entry in Treatment Period 1 Enrolment of a subject completing the run-in period into Treatment Period 1 will not be allowed if any of the following applies: 1. Admitted to the hospital due to asthma exacerbation during the run-in period. 2. Had upper or lower respiratory tract infection during the 2 weeks just before Visit 2. 3. Used prohibited drugs during the 2 weeks just before Visit 2. 4. Is not eligible for the study in the investigator's/subinvestigator's judgment. Exclusion Criteria for Entry in Treatment Period 2 Enrolment of a subject completing the washout period into Treatment Period 2 will not be allowed if any of the following applies: 1. Admitted to the hospital due to asthma exacerbation during the washout period. 2. Had upper or lower respiratory tract infection during the 2 weeks just before Visit 4. 3. Used prohibited drugs during the 2 weeks just before Visit 4. 4. Is not eligible for entry in Treatment Period 2 in the investigator's/subinvestigator's judgment.
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2008-19-01
Actual study completion date
2008-19-01
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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