Clinical Assessment Of GW815SF Salmeterol/Fluticasone Propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-

Bronchial Asthma Clinical Trial

Official title:

Clinical Assessment of GW815SF Salmeterol/Fluticasone Propionate (HFA MDI) in Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00449046
• Other study ID #: 110101
• Status: Completed
• Phase: Phase 3
• First received: March 16, 2007
• Last updated: April 16, 2015
• Start date: March 2007
• Est. completion date: November 2007

Study information

• Verified date: April 2015
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This study evaluates the long-term (24-week) safety and efficacy of GW815SF Salmeterol/fluticasone propionate(HFA MDI) 50/100mcg(administered as 2 inhalations of 25/50mcg) bid in pediatric patients with bronchial asthma.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• 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 and if she agrees to undergo pregnancy testing at the protocol-specified timings and to take contraceptive measures without fail during the study period.

• Written informed consent must be obtained from the 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 100-200µg/day or equivalent) for at least 4 weeks prior to Visit 1.

• Is suitable, in the investigator's/subinvestigator's judgment, for treatment with GW815SF HFA MDI 25/50µg (administered as 2 inhalations of 25/50µg) bid.

• Able to use a peak flow meter in a correct manner in the investigator's/subinvestigator's judgment.

• Able to use MDI 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 A subject will be considered eligible for inclusion in the treatment period only if he/she has completed the run-in period and meets the following criterion.

1. Has been able, in the investigator's/subinvestigator's judgment, to make entries in the asthma diary and measure PEF, as directed, during the run-in period.

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

A subject who applies to any of the following criteria is not eligible for the study:

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Bronchial Asthma

Intervention

Drug:
• GW815SF Salmeterol/Fluticasone propionate(HFA MDI)

Locations

Country	Name	City	State
Japan	GSK Clinical Trials Call Center	Funabashi, Chiba
Japan	GSK Clinical Trials Call Center	Setagaya, Tokyo
Japan	GSK Clinical Trials Call Center	Takasaki, Gunma

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Most Frequent Adverse Events - On Therapy	Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.	Baseline to Week 24	No
Primary	Serious Adverse Events (SAEs) - On Therapy	Number of participants considered by the investigator to be related to study medication.; Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination were included. Frequency threshold of reported SAE's is 0%(100% reported)	Baseline to Week 24	No
Secondary	Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24	PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.	Baseline and during Weeks 1-24	No
Secondary	Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24	Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.	Baseline and during Weeks 1-24	No
Secondary	Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24	The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.	Baseline and during Weeks 1-24	No
Secondary	Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24	Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.	Baseline and during Weeks 1-24	No
Secondary	Number of Participants With Symptom-Free Nights and Days		Baseline and Week 24	No
Secondary	Number of Participants With Rescue Medication-Free Nights and Days	Rescue free means without the use of other medication.	Baseline and Week 24	No