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Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents

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

Condition(s) targeted: Asthma

Intervention: Fluticasone propionate (Drug); Fluticasone furoate (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: GlaxoSmithKline

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

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.

Clinical Details

Official 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.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean Change From Baseline in Clinic Visit Trough Evening (Pre-bronchodilator and Pre-dose) Forced Expiratory Volume in One Second (FEV1) at the End of the 24 Week Treatment Period

Secondary outcome:

Change From Baseline in the Percentage of Rescue-free 24-hour (hr) Periods at the End of the 24-week Treatment Period

Mean Change From Baseline in Daily Trough Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period

Mean Change From Baseline in Daily Morning (AM) PEF Averaged Over the First 12 Weeks and 24 Weeks of the 24-week Treatment Period

Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods at the End of the 24-week Treatment Period

Change From Baseline in the Total Asthma Quality of Life Questionnaire (AQLQ) (+12) Score at Week 12 and Week 24

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.

Eligibility

Minimum age: 12 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed informed consent

- Outpatient at least 12 years of age

- Both genders; females of child bearing potential must be willing to use approved

birth control method

- Pre-bronchodilator FEV1 of 40-90% predicted

- Reversibility FEV1 of at least 12% and 200mLs

- Current asthma therapy that includes an inhaled corticosteroid for at least 4 weeks

prior to first visit Exclusion Criteria:

- History of life threatening asthma

- Respiratory infection or candidiasis

- Asthma exacerbation within 6 months prior to first visit

- Concurrent respiratory disease or other disease that would confound study

participation or affect subject safety

- Allergies to study drugs, study drug excipients, medications related to study drugs

- Taking another investigational medication or medication prohibited for use during

this study

Locations and Contacts

GSK Investigational Site, Gozée 6534, Belgium

GSK Investigational Site, Halen 3544, Belgium

GSK Investigational Site, Hamois (Natoye) 5360, Belgium

GSK Investigational Site, Tremelo 3120, Belgium

GSK Investigational Site, Berlin 12157, Germany

GSK Investigational Site, Berlin 12043, Germany

GSK Investigational Site, Berlin 10367, Germany

GSK Investigational Site, Debica 39-200, Poland

GSK Investigational Site, Kielce 25-751, Poland

GSK Investigational Site, Lodz 93-513, Poland

GSK Investigational Site, Lomza 18-400, Poland

GSK Investigational Site, Sopot 81-741, Poland

GSK Investigational Site, Szczecin 71-124, Poland

GSK Investigational Site, Bucharest 020125, Romania

GSK Investigational Site, Bucharest 050526, Romania

GSK Investigational Site, Bucharest 050042, Romania

GSK Investigational Site, Bucharest 022102, Romania

GSK Investigational Site, Bucuresti 041914, Romania

GSK Investigational Site, Iasi 700115, Romania

GSK Investigational Site, Birmingham, Alabama 35209, United States

GSK Investigational Site, Montgomery, Alabama 36106, United States

GSK Investigational Site, Green Valley, Arizona 85614, United States

GSK Investigational Site, Little Rock, Arkansas 72205, United States

GSK Investigational Site, Ruedersdorf, Brandenburg 15562, Germany

GSK Investigational Site, Schwedt, Brandenburg 16303, Germany

GSK Investigational Site, Bakerfield, California 93301, United States

GSK Investigational Site, Encinitas, California 92024, United States

GSK Investigational Site, Fresno, California 93720, United States

GSK Investigational Site, Huntington Beach, California 92647, United States

GSK Investigational Site, Long Beach, California 90808, United States

GSK Investigational Site, Long Beach, California 90813, United States

GSK Investigational Site, Newport Beach, California 92663, United States

GSK Investigational Site, Orange, California 92868, United States

GSK Investigational Site, Riverside, California 92506, United States

GSK Investigational Site, Rolling Hills Estates, California 90274, United States

GSK Investigational Site, San Diego, California 92128, United States

GSK Investigational Site, San Diego, California 92103-8415, United States

GSK Investigational Site, San Diego, California 92120, United States

GSK Investigational Site, San Diego, California 92123, United States

GSK Investigational Site, San Jose, California 95117, United States

GSK Investigational Site, Cutler Bay, Florida 33189, United States

GSK Investigational Site, Edgewater, Florida 32132, United States

GSK Investigational Site, Miami, Florida 33185, United States

GSK Investigational Site, Miami, Florida 33155, United States

GSK Investigational Site, Orlando, Florida 32806, United States

GSK Investigational Site, Albany, Georgia 31707, United States

GSK Investigational Site, Columbus, Georgia 31904, United States

GSK Investigational Site, Eschwege, Hessen 37269, Germany

GSK Investigational Site, Shiloh, Illinois 62269, United States

GSK Investigational Site, Lenexa, Kansas 66215, United States

GSK Investigational Site, Owensboro, Kentucky 42301, United States

GSK Investigational Site, Metairie, Louisiana 70006, United States

GSK Investigational Site, Sunset, Louisiana 70584, United States

GSK Investigational Site, Baltimore, Maryland 21236, United States

GSK Investigational Site, Columbia, Missouri 65203, United States

GSK Investigational Site, St. Louis, Missouri 63141, United States

GSK Investigational Site, Bellevue, Nebraska 68123-4303, United States

GSK Investigational Site, Las Vegas, Nevada 89119, United States

GSK Investigational Site, Hannover, Niedersachsen 30173, Germany

GSK Investigational Site, Essen, Nordrhein-Westfalen 45359, Germany

GSK Investigational Site, Shelby, North Carolina 28152, United States

GSK Investigational Site, Canton, Ohio 44718, United States

GSK Investigational Site, Dayton, Ohio 45459, United States

GSK Investigational Site, Franklin, Ohio 45005, United States

GSK Investigational Site, Oklahoma City, Oklahoma 73103, United States

GSK Investigational Site, Medford, Oregon 97504, United States

GSK Investigational Site, Collegeville, Pennsylvania 19426, United States

GSK Investigational Site, Pittsburgh, Pennsylvania 15241, United States

GSK Investigational Site, Magdeburg, Sachsen-Anhalt 39112, Germany

GSK Investigational Site, Greenville, South Carolina 29607, United States

GSK Investigational Site, Orangeburg, South Carolina 29118, United States

GSK Investigational Site, Austin, Texas 78750, United States

GSK Investigational Site, Dallas, Texas 75225, United States

GSK Investigational Site, Houston, Texas 77054, United States

GSK Investigational Site, Kerrville, Texas 78028, United States

GSK Investigational Site, San Antonio, Texas 78224, United States

GSK Investigational Site, San Antonio, Texas 78229, United States

GSK Investigational Site, San Antonio, Texas 78251, United States

GSK Investigational Site, Waco, Texas 76712, United States

GSK Investigational Site, Erfurt, Thueringen 99084, Germany

GSK Investigational Site, Schmoelln, Thueringen 04626, Germany

GSK Investigational Site, Richmond, Virginia 23225, United States

Additional Information

Starting date: June 2010
Last updated: January 30, 2014

Page last updated: August 23, 2015

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