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

NCT00449046 | Completed Phase 3 Results

• 1 other identifier: 110101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Bronchial Asthma

Keywords

salmeterol/fluticasone propionate combination; pediatric bronchial asthma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (6)

• Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24

  Baseline and during Weeks 1-24

• Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24

  Baseline and during Weeks 1-24

• Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24

  Baseline and during Weeks 1-24

• Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24

  Baseline and during Weeks 1-24

• Number of Participants With Symptom-Free Nights and Days

  Baseline and Week 24

Interventions

GW815SF Salmeterol/Fluticasone propionate(HFA MDI) DRUG

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• \. 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.

You may not qualify if:

• 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.
• A subject who applies to any of the following criteria is not eligible for the study:
• Admitted to the hospital due to asthma exacerbation during the run-in period.
• Had upper or lower respiratory tract infection during the 2 weeks just before Visit 2.
• Used prohibited drugs during the 2 weeks just before Visit 2.
• Is not eligible for the study in the investigator's/subinvestigator's judgment.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Clinical Trials Call Center

Funabashi, Chiba, 273, Japan

Location

GSK Clinical Trials Call Center

Setagaya, Tokyo, 157, Japan

Location

GSK Clinical Trials Call Center

Takasaki, Gunma, 370, Japan

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials, MD

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 16, 2007
• First Posted: March 19, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 6, 2015
• Results First Posted: August 4, 2009

Record last verified: 2015-04

Locations

JP (3)