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Trial record 34 of 319 for:    FLUTICASONE AND SALMETEROL

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

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ClinicalTrials.gov Identifier: NCT00448435
Recruitment Status : Completed
First Posted : March 16, 2007
Results First Posted : August 11, 2009
Last Update Posted : June 8, 2010
Sponsor:
Information provided by:
GlaxoSmithKline

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.


Condition or disease Intervention/treatment Phase
Bronchial Asthma Drug: GW815SF HFA MDI Drug: salmeterol and fluticasone propionate Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : April 2007
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Active Comparator: SLM+FP First
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
salmeterol and fluticasone propionate combination
Other Name: salmeterol/fluticasone propionate combination

Drug: salmeterol and fluticasone propionate
salmeterol + fluticasone propionate

Active Comparator: SFC First
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
salmeterol and fluticasone propionate combination
Other Name: salmeterol/fluticasone propionate combination

Drug: salmeterol and fluticasone propionate
salmeterol + fluticasone propionate

Experimental: SFC
SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).
Drug: GW815SF HFA MDI
salmeterol and fluticasone propionate combination
Other Name: salmeterol/fluticasone propionate combination




Primary Outcome Measures :
  1. Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods [ Time Frame: Crossover Period Weeks 1-4, and 7-10 ]
    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]).


Secondary Outcome Measures :
  1. Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods [ Time Frame: Crossover Period Weeks 1-4, 7-10 ]
    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.

  2. Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods [ Time Frame: Crossover Period weeks 1-4, 7-10 ]
    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.

  3. Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods [ Time Frame: Crossover Period weeks 1-4, 7-10 ]
    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.

  4. Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods [ Time Frame: Crossover Period Weeks 1-4, 7-10 ]
    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.

  5. Percentage of Subjects With Symptom-Free Nights & Days [ Time Frame: Crossover Period Week 1-4, 7-10 ]
    Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment

  6. Percentage of Subjects With Rescue Medication-Free Nights and Days [ Time Frame: Crossover Period Weeks 1-4, 7-10 ]
    Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment

  7. Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period [ Time Frame: Extension Period Weeks 11-30 ]
    Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30).

  8. Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period [ Time Frame: Extension Period weeks 11-30 ]
    Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).

  9. Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period [ Time Frame: Extension Period weeks 11-30 ]
    Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).

  10. Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period [ Time Frame: Extension Period weeks 11-30 ]
    Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).

  11. Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period [ Time Frame: Extension Period weeks 11-30 ]
    Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).

  12. Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment [ Time Frame: Extension Period Weeks 11-30 ]
    Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30).

  13. Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment [ Time Frame: Extension Period Weeks 11-30 ]
    Percentage of subjects with Rescue Medication Free Nights & Days after 20 weeks of Treatment (at week 30).



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448435


Locations
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Japan
GSK Investigational Site
Chiba, Japan, 260-0001
GSK Investigational Site
Kanagawa, Japan, 245-0018
GSK Investigational Site
Saitama, Japan, 360-0018
GSK Investigational Site
Saitama, Japan, 360-0812
GSK Investigational Site
Tokyo, Japan, 154-0002
GSK Investigational Site
Tokyo, Japan, 154-0017
GSK Investigational Site
Tokyo, Japan, 158-0083
GSK Investigational Site
Tokyo, Japan, 158-0097
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00448435     History of Changes
Other Study ID Numbers: 110099
First Posted: March 16, 2007    Key Record Dates
Results First Posted: August 11, 2009
Last Update Posted: June 8, 2010
Last Verified: June 2010
Keywords provided by GlaxoSmithKline:
Salmeterol
Fluticasone propionate
Salmeterol/Fluticasone propionate combination
Pediatric bronchial asthma
Additional relevant MeSH terms:
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Fluticasone
Salmeterol Xinafoate
Fluticasone-Salmeterol Drug Combination
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists