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Home > Protocol Summaries: Compounds > fluticasone furoate > Protocol Summary for 112059

Protocol Summary for 112059

Protocol Summary
Protocol Id: 112059
Secondary Ids:
  • n/a
Title: A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.
Phase: phase 3
Acronym: n/a
FDA Regulated Intervention?: Yes
Section 801 Clinical Trial?: Yes
Delayed Posting: No
IND/IDE Protocol?: yes
IND/IDE Grantor: CDER
IND/IDE Number: 70297
IND/IDE Serial Number: 0126
Has Expanded Access?: no
Study Type: Interventional
Oversight Authority:
  • United States: Food and Drug Administration
  • Poland: URZ.D REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH,CEBK
  • United States: Food and Drug Administartion
  • Belgium: SPF Sante publique
  • Germany: Bundesinstitut für Arzneimittel und Medizinprodukte
  • Romania: Agentia Nationala a Medicamentului
Collaborators:
Brief Summary: A randomised, double-blind, double-dummy, placebo controlled (with rescue medication), multicenter study to evaluate the efficacy and safety of Fluticasone Furoate inhalation powder in the treatment of persistent asthma in adults and adolescents.
Detailed Description: This is a multi-center, randomized, double-blind, double-dummy, parallel-group study to compare the efficacy and safety of Fluticasone Furoate Inhalation Powder 100mcg once daily and Fluticasone Propionate Inhalation Powder 250mcg twice daily with Placebo. Subjects will participate in the study for up to a maximum of 29 weeks (including screening, treatment and follow-up contact). The primary endpoint consists of change from baseline in clinic visit trough (pre-bronchodilator and pre-dose) FEV1 at the end of the 24 week treatment period. The nominated powered secondary endpoint is the change from baseline in the percentage of rescue-free 24 hour periods during the 24-week treatment period. Safety assessments include adverse events, oropharyngeal examinations, clinical chemistry and urine cortisol excretion. For subjects who have consented for pharmacogenetics, a blood sample will also be taken for pharmacogenetic analysis.
Record Verification Date: September 2012
Status: Completed
Why Study Stopped:
Study Start Date: June 2010
Study Completion Date: January 2012
Study Completion Date Type: Actual
Primary Completion Date: January 2012
Primary Completion Date Type: Actual
Primary Purpose: treatment
Allocation: Randomized
Masking: Double Blind
Masked Subject: yes
Masked Caregiver: yes
Masked Investigator: yes
Masked Assessor: yes
Study Design (Assignment): Parallel Assignment
Study Classification (Endpoint): Safety/Efficacy Study
Primary Outcomes:
  • Change from baseline in clinic trough (pre-bronchodilator and pre-dose) FEV1 At the end of the 24 week treatment period
Secondary Outcomes:
  • Change from baseline in total AQLQ (+12) score At end of 12 weeks and the full 24 week treatment period
  • Mean change from baseline in daily AM PEF Averaged over the 24 week treatment period
  • Change from baseline in percentage of symptom free 24 hour periods At the end of the 24 week treatment period
  • Mean change from baseline in daily trough (pre-dose and pre-rescue bronchodilator) PM PEF Averaged over the 24 week treatment period
  • Change in the percentage of rescue free 24 hour periods At the end of the 24 week treatment period
Conditions:
  • Asthma
Keywords:
  • fluticasone propionate
  • Fluticasone furoate
Eligibility Criteria: Click to view inclusion/exclusion criteria
Gender: Both
Minimum Age: 12 Year
Maximum Age:
Enrollment: 350
Enrollment Type: Actual
Healthy Volunteers?: none
Central Contact: Call Center
Central Contact Phone: 877-379-3718
Central Contact Email: GSKClinicalSupportHD@gsk.com
Backup Central Contact:
Backup Central Contact Phone:
Backup Central Contact Email:
Overall Study Official: GSK Clinical Trials
Overall Study Official Affiliation: GlaxoSmithKline
Overall Study Official Role: Study Director
Responsible Party Name/Official Title: Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization: GSK Clinical Disclosure
Location and Contact Information: Click to view location information