Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma

Bronchial Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00448435
• Other study ID #: 110099
• Status: Completed
• Phase: Phase 3
• First received: March 14, 2007
• Last updated: June 3, 2010
• Start date: April 2007
• Est. completion date: January 2008

Study information

• Verified date: June 2010
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical 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.

To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 14 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• GW815SF HFA MDI
salmeterol and fluticasone propionate combination
• salmeterol and fluticasone propionate
salmeterol + fluticasone propionate

Locations

Country	Name	City	State
Japan	GSK Investigational Site	Chiba
Japan	GSK Investigational Site	Kanagawa
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Saitama
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo
Japan	GSK Investigational Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]).	Crossover Period Weeks 1-4, and 7-10	No
Secondary	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.	Crossover Period Weeks 1-4, 7-10	No
Secondary	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.	Crossover Period weeks 1-4, 7-10	No
Secondary	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.	Crossover Period weeks 1-4, 7-10	No
Secondary	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.	Crossover Period Weeks 1-4, 7-10	No
Secondary	Percentage of Subjects With Symptom-Free Nights & Days	Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment	Crossover Period Week 1-4, 7-10	No
Secondary	Percentage of Subjects With Rescue Medication-Free Nights and Days	Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment	Crossover Period Weeks 1-4, 7-10	No
Secondary	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).	Extension Period Weeks 11-30	No
Secondary	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).	Extension Period weeks 11-30	No
Secondary	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).	Extension Period weeks 11-30	No
Secondary	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).	Extension Period weeks 11-30	No
Secondary	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).	Extension Period weeks 11-30	No
Secondary	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).	Extension Period Weeks 11-30	No
Secondary	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).	Extension Period Weeks 11-30	No