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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00449046
First received: March 16, 2007
Last updated: June 18, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Bronchial Asthma
Drug: GW815SF Salmeterol/Fluticasone propionate(HFA MDI)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Assessment of GW815SF Salmeterol/Fluticasone Propionate (HFA MDI) in Pediatric Patients With Bronchial Asthma -A Long Term (24-Week) Study-

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Most Frequent Adverse Events - On Therapy [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Serious Adverse Events (SAEs) - On Therapy [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24 [ Time Frame: Baseline and during Weeks 1-24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24 [ Time Frame: Baseline and during Weeks 1-24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24 [ Time Frame: Baseline and during Weeks 1-24 ] [ Designated as safety issue: No ]
  • Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24 [ Time Frame: Baseline and during Weeks 1-24 ] [ Designated as safety issue: No ]
  • Number of Participants With Symptom-Free Nights and Days [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]
  • Number of Participants With Rescue Medication-Free Nights and Days [ Time Frame: Baseline and Week 24 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: March 2007
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   5 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449046

Locations
Japan
GSK Clinical Trials Call Center
Funabashi, Chiba, Japan, 273
GSK Clinical Trials Call Center
Setagaya, Tokyo, Japan, 157
GSK Clinical Trials Call Center
Takasaki, Gunma, Japan, 370
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00449046     History of Changes
Other Study ID Numbers: 110101
Study First Received: March 16, 2007
Results First Received: November 21, 2008
Last Updated: June 18, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
salmeterol/fluticasone propionate combination
pediatric bronchial asthma

Additional relevant MeSH terms:
Asthma
Anti-Asthmatic Agents
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Fluticasone
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Allergic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014