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

NCT00448435 | Completed Phase 3 Results

• 1 other identifier: 110099
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Bronchial Asthma

Keywords

Salmeterol; Fluticasone propionate; Salmeterol/Fluticasone propionate combination; Pediatric bronchial asthma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods

  Crossover Period Weeks 1-4, 7-10

• Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods

  Crossover Period weeks 1-4, 7-10

• Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods

  Crossover Period weeks 1-4, 7-10

• Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods

  Crossover Period Weeks 1-4, 7-10

• Percentage of Subjects With Symptom-Free Nights & Days

  Crossover Period Week 1-4, 7-10

Study Arms (3)

SLM+FP First

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).

Drug: GW815SF HFA MDI; Drug: salmeterol and fluticasone propionate

SFC First

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).

Drug: GW815SF HFA MDI; Drug: salmeterol and fluticasone propionate

SFC

EXPERIMENTAL

SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).

Drug: GW815SF HFA MDI

Interventions

GW815SF HFA MDI DRUG

salmeterol and fluticasone propionate combination

Also known as: salmeterol/fluticasone propionate combination

SFC; SFC First; SLM+FP First

salmeterol and fluticasone propionate DRUG

salmeterol + fluticasone propionate

SFC First; SLM+FP First

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 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.
• 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 .
• Was able to perform entry in the asthma diary and PEF measurements 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.

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.
• Enrolment of a subject completing the run-in period into Treatment Period 1 will not be allowed if any of the following applies:
• 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 (8)

GSK Investigational Site

Chiba, 260-0001, Japan

Location

GSK Investigational Site

Kanagawa, 245-0018, Japan

Location

GSK Investigational Site

Saitama, 360-0018, Japan

Location

GSK Investigational Site

Saitama, 360-0812, Japan

Location

GSK Investigational Site

Tokyo, 154-0002, Japan

Location

GSK Investigational Site

Tokyo, 154-0017, Japan

Location

GSK Investigational Site

Tokyo, 158-0083, Japan

Location

GSK Investigational Site

Tokyo, 158-0097, Japan

Location

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Salmeterol Xinafoate; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Fluticasone; Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 14, 2007
• First Posted: March 16, 2007
• Study Start: April 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: June 8, 2010
• Results First Posted: August 11, 2009

Record last verified: 2010-06

Locations

JP (8)