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

Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bronchial Asthma

Intervention: GW815SF HFA MDI (Drug); salmeterol and fluticasone propionate (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

Official(s) and/or principal investigator(s):
GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline

Summary

To evaluate the efficacy and safety of GW815SF HFA MDI 25/50g 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25g 1 inhalation bid plus fluticasone propionate DPI 50g 1 inhalation bid in paediatric patients with asthma. To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50g 1 inhalation bid in paediatric patients with asthma.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods

Secondary outcome:

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

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

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

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

Percentage of Subjects With Symptom-Free Nights & Days

Percentage of Subjects With Rescue Medication-Free Nights and Days

Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period

Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period

Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period

Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period

Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period

Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment

Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment

Eligibility

Minimum age: 5 Years. Maximum age: 14 Years. Gender(s): Both.

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.

Locations and Contacts

GSK Investigational Site, Chiba 260-0001, Japan

GSK Investigational Site, Kanagawa 245-0018, Japan

GSK Investigational Site, Saitama 360-0018, Japan

GSK Investigational Site, Saitama 360-0812, Japan

GSK Investigational Site, Tokyo 154-0002, Japan

GSK Investigational Site, Tokyo 154-0017, Japan

GSK Investigational Site, Tokyo 158-0083, Japan

GSK Investigational Site, Tokyo 158-0097, Japan

Additional Information

Starting date: April 2007
Last updated: June 3, 2010

Page last updated: August 23, 2015

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