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Trial record 47 of 320 for:    FLUTICASONE AND SALMETEROL

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

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ClinicalTrials.gov Identifier: NCT00449046
Recruitment Status : Completed
First Posted : March 19, 2007
Results First Posted : August 4, 2009
Last Update Posted : May 6, 2015
Sponsor:
Information provided by:
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE March 16, 2007
First Posted Date  ICMJE March 19, 2007
Results First Submitted Date  ICMJE November 21, 2008
Results First Posted Date  ICMJE August 4, 2009
Last Update Posted Date May 6, 2015
Study Start Date  ICMJE March 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2015)
  • Most Frequent Adverse Events - On Therapy [ Time Frame: Baseline to Week 24 ]
    Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead electrocardiogram (ECG), Oropharyngeal examination were included.
  • Serious Adverse Events (SAEs) - On Therapy [ Time Frame: Baseline to Week 24 ]
    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)
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2007)
Safety: Adverse events, Clinical laboratory tests, Adrenocortical function test, Physical examinations, 12-lead ECG, Oropharyngeal examination
Change History Complete list of historical versions of study NCT00449046 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2015)
  • Change From Baseline in Morning Peak Expiratory Flow (PEF) During Weeks 1-24 [ Time Frame: Baseline and during Weeks 1-24 ]
    PEF taken daily and average used for week 1-24 value. The peak expiratory flow rate measures how fast a person can (exhale) air. Then, compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
  • Change From Baseline in Percent Predicted Morning Peak Expiratory Flow (PEF) During Weeks 1-24 [ Time Frame: Baseline and during Weeks 1-24 ]
    Percent Predicted Morning Peak Expiratory flow were the percent of patients that were predicted to have their Peak expiratory flow in the morning.
  • Change From Baseline in Evening Peak Expiratory Flow (PEF) During Weeks 1-24 [ Time Frame: Baseline and during Weeks 1-24 ]
    The peak expiratory flow rate measures how fast a person can (exhale) air. Then compares it to normal flow rates to predict obstruction and disease. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
  • Change From Baseline in Circadian Variation in Peak Expiratory Flow (PEF) During Weeks 1-24 [ Time Frame: Baseline and during Weeks 1-24 ]
    Circadian Variation means the various changes in a day. The peak expiratory flow rate measures how fast a person can (exhale) air using a mini-Wright peak flow meter. The average PEF for a child or adolescent whose height is 43" is 147 L/min, whose height is 66" is 454 L/min.
  • Number of Participants With Symptom-Free Nights and Days [ Time Frame: Baseline and Week 24 ]
  • Number of Participants With Rescue Medication-Free Nights and Days [ Time Frame: Baseline and Week 24 ]
    Rescue free means without the use of other medication.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2007)
Efficacy: Morning and evening PEF, Diurnal variation in PEF, Asthma symptoms, Rescue medication
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Assessment Of GW815SF Salmeterol/Fluticasone Propionate(HFA MDI) In Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-
Official Title  ICMJE Clinical Assessment of GW815SF Salmeterol/Fluticasone Propionate (HFA MDI) in Pediatric Patients With Bronchial Asthma -A Long Term (24-week) Study-
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bronchial Asthma
Intervention  ICMJE Drug: GW815SF Salmeterol/Fluticasone propionate(HFA MDI)
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2009)
40
Original Enrollment  ICMJE
 (submitted: March 16, 2007)
35
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date November 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00449046
Other Study ID Numbers  ICMJE 110101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP