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
Completed
Completed
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:
Drug: GW815SF HFA MDI
Drug: salmeterol and fluticasone propionate
Enrollment:
51
Observational study model:
Not applicable
Primary completion date:
2008-19-01
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 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:
- Exclusion Criteria for Entry in Run-in Period
- A patient who applies any of the following criteria is not eligible for the study:
Inclusion and exclusion 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
Completed
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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