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Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
This study has been completed.
Study NCT00448435   Information provided by GlaxoSmithKline
First Received: March 14, 2007   Last Updated: October 30, 2009   History of Changes

March 14, 2007
October 30, 2009
April 2007
January 2008   (final data collection date for 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 ] [ Designated as safety issue: No ]
Change from baseline in mean morning PEF during the 4-week treatment period
Complete list of historical versions of study NCT00448435 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods [ Time Frame: Crossover Period weeks 1-4, 7-10 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Symptom-Free Nights & Days [ Time Frame: Crossover Period Week 1-4, 7-10 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Rescue Medication-Free Nights and Days [ Time Frame: Crossover Period Weeks 1-4, 7-10 ] [ Designated as safety issue: No ]
  • Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period [ Time Frame: Extension Period Weeks 11-30 ] [ Designated as safety issue: No ]
  • Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period [ Time Frame: Extension Period weeks 11-30 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period [ Time Frame: Extension Period weeks 11-30 ] [ Designated as safety issue: No ]
  • Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period [ Time Frame: Extension Period weeks 11-30 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment [ Time Frame: Extension Period Weeks 11-30 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment [ Time Frame: Extension Period Weeks 11-30 ] [ Designated as safety issue: No ]
  • Efficacy:
  • Morning and evening PEF, Diurnal variation in PEF, Asthma symptoms, Rescue medication
  • Safety:
  • Adverse events, Clinical laboratory tests, Physical examinations, 12-lead ECG, Oropharyngeal test
 
Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
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.

 
Phase III
Interventional
Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study
Bronchial Asthma
  • Drug: GW815SF HFA MDI
  • Drug: salmeterol and fluticasone propionate
  • 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).
  • 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).
  • Experimental: SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
51
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
5 Years to 14 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00448435
Study Director, GSK
110099
GlaxoSmithKline
 
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP