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Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma
This study has been completed.
First Received: March 14, 2007   Last Updated: October 15, 2008   History of Changes
Sponsored by: GlaxoSmithKline
Information provided by: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00448435
  Purpose

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.


Condition Intervention Phase
Bronchial Asthma
Drug: salmeterol/fluticasone propionate
Drug: GW815SF HFA MDI
Drug: salmeterol and fluticasone propionate
Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Change from baseline in mean morning PEF during the 4-week treatment period

Secondary Outcome Measures:
  • Efficacy: Morning and evening PEF, Diurnal variation in PEF, Asthma symptoms, Rescue medication Safety: Adverse events, Clinical laboratory tests, Physical examinations, 12-lead ECG, Oropharyngeal test
  • Efficacy: 1. Morning PEF (excluding the primary endpoint) 2. Percent morning PEF to predicted normal 3. Percent morning PEF to personal best
  • 4. Evening PEF 5. Percent diurnal PEF variations 6. Percentages of symptom free nights and days
  • 7. Percentages of nighttime or daytime symptom free subjects 8. Nighttime and daytime asthma symptom scores 9. Percentage of rescue medication free days
  • 10. Percentage of subjects with no rescue medication use 11. Rescue medication use (number of use)
  • Safety: 1. Adverse events (AEs) 2. Clinical laboratory tests (hematology, clinical chemistry) 3. Physical examinations (blood pressure, pulse rate)
  • 4. 12-lead ECG 5. Oropharyngeal test (only if oral fungus infection is suspected)

Estimated Enrollment: 45
Study Start Date: April 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448435

Locations
Japan
GSK Investigational Site
Kanagawa, Japan, 245-0018
GSK Investigational Site
Chiba, Japan, 260-0001
GSK Investigational Site
Saitama, Japan, 360-0018
GSK Investigational Site
Saitama, Japan, 360-0812
GSK Investigational Site
Tokyo, Japan, 158-0083
GSK Investigational Site
Tokyo, Japan, 154-0017
GSK Investigational Site
Tokyo, Japan, 158-0057
GSK Investigational Site
Tokyo, Japan, 154-0002
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GSK ( Study Director )
Study ID Numbers: 110099
Study First Received: March 14, 2007
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00448435     History of Changes
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Salmeterol
Fluticasone propionate
Salmeterol/Fluticasone propionate combination
Pediatric bronchial asthma

Study placed in the following topic categories:
Anti-Inflammatory Agents
Neurotransmitter Agents
Salmeterol
Bronchial Diseases
Adrenergic Agents
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Asthma
Anti-Allergic Agents
Adrenergic Agonists
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Fluticasone
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

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

ClinicalTrials.gov processed this record on July 02, 2009