Clinical trial NCT01018186: Fluticasone Furoate/GW642444 Inhalation Powder Long-Term Safety Study
Official title: A Randomized, Double-Blind, Double Dummy, Active Comparator, Parallel Group, Multicenter Study to Evaluate the Safety of Once-Daily Fluticasone Furoate/GW642444 Inhalation Powder for 52 Weeks in Adolescent and Adult Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2009-11-23
Enrollment: 503
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety of fluticasone furoate/GW642444


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of asthma
* Reversibility FEV1 of twelve percent or greater and two hundred milliliters and greater approximately ten to forty minutes following two to four inhalations of albuterol
* FEV1 greater than or equal to fifty percent of predicted
* Currently using moderate to high dose inhaled corticosteroid therapy

Exclusion Criteria:

* History of life threatening asthma
* Respiratory infection or oral candidiasis
* Asthma exacerbation
* Uncontrolled disease or clinical abnormality
* Allergies
* Taking another investigational medication or prohibited medication

Primary outcomes:
measure: Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period
timeFrame: From the start of study medication until Visit 11 (Week 52)/Early Withdrawal
measure: Number of Participants With Severe Asthma Exacerbations During the Treatment Period
timeFrame: From the start of study medication until Visit 11 (Week 52)/Early Withdrawal
measure: Change From Baseline in Albumin and Total Protein at Week 12, Week 28, and Week 52/Early Withdrawal
timeFrame: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
measure: Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyltransferase (GGT) at Week 12, Week 28, and Week 52/Early Withdrawal
timeFrame: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
measure: Change From Baseline in Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Creatinine at Week 12, Week 28, and Week 52/Early Withdrawal
timeFrame: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
measure: Change From Baseline in Chloride, Carbon Dioxide Content/Bicarbonate, Glucose, Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Week 12, Week 28, and Week 52/Early Withdrawal
timeFrame: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
measure: Change From Baseline in the Percentage of Basophils, Eosinophils, Hematocrit, Lymphocytes, Monocytes, and Segmented Neutrophils in the Blood at Week 12, Week 28, and Week 52/Early Withdrawal
timeFrame: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
measure: Change From Baseline in Eosinophil Count, Total Absolute Neutrophil Count (ANC), Platelet Count, and White Blood Cell (WBC) Count at Week 12, Week 28, and Week 52/Early Withdrawal
timeFrame: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
measure: Change From Baseline in Hematocrit at Week 12, Week 28, and Week 52/Early Withdrawal
timeFrame: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
measure: Change From Baseline in Hemoglobin at Week 12, Week 28, and Week 52/Early Withdrawal
timeFrame: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
measure: Number of Participants With the Indicated Shift From Baseline to High, Normal or no Change, and Low Post-Baseline Values for Urinary Cortisol Excretion
timeFrame: Baseline; Week 12, Week 28, and Week 52/Early Withdrawal
measure: Ratio of 24-hour Urinary Cortisol Excretion at Week 12 to Baseline
timeFrame: Baseline and Week 12
measure: Ratio of 24-hour Urinary Cortisol Excretion at Week 28 to Baseline
timeFrame: Baseline and Week 28
measure: Ratio of 24-hour Urinary Cortisol Excretion at Week 52 to Baseline
timeFrame: Baseline and Week 52
measure: Number of Participants With Evidence of Oral Candidiasis at Any Time Post-Baseline
timeFrame: From Baseline until Visit 11/Early Withdrawal (52 weeks)
measure: Maximum Change From Baseline in Systolic Blood Pressure (SBP) and Minimum Change From Baseline in Diastolic Blood Pressure (DBP)
timeFrame: From Baseline until Visit 11/Early Withdrawal (52 weeks)
measure: Maximum Change From Baseline in Pulse Rate
timeFrame: From Baseline until Visit 11/Early Withdrawal (52 weeks)
measure: Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Posterior Subcapsular Opacity (P) at Week 28 and Week 52
timeFrame: Baseline; Week 28, and Week 52
measure: Number of Participants With the Indicated Change From Baseline in Intraocular Pressure (IOP) at Week 28 and Week 52
timeFrame: Baseline; Week 28 and Week 52
measure: Change From Baseline in Horizontal Cup-to-disc Ratio at Week 28 and Week 52
timeFrame: Baseline; Week 28 and Week 52
measure: Number of Participants With the Indicated Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Cortical Opacity (C) at Week 28 and Week 52
timeFrame: Baseline; Week 28 and Week 52
measure: Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Color (NC) at Week 28 and Week 52
timeFrame: Baseline; Week 28 and Week 52
measure: Change From Baseline in Lens Opacities Classification System, Version III (LOCS III) Nuclear Opalescence (NO) at Week 28 and Week 52
timeFrame: Baseline; Week 28 and Week 52
measure: Change From Baseline in the Logarithm of the Minimum Angle of Resolution (LogMAR) Visual Acuity at Week 28 and Week 52
timeFrame: Baseline; Week 28 and Week 52
measure: Maximum Change From Baseline in the QT Interval Using Bazett's Correction (QTcB) and QT Interval Using Fridericia's Correction (QTcF)
timeFrame: Baseline; Week 2, Week 12, Week 28, and Week 52/Early Withdrawal
measure: Mean 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data
timeFrame: 0-24 hours at Screening, Day 1, Week 28, and Week 52
measure: Maximum 24 Hour Holter Heart Rate for Participants With at Least 16 Hours of Recorded Data
timeFrame: 0-24 hours at Screening, Day 1, Week 28, and Week 52
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United States
facility: GSK Investigational Site
state: Alabama
city: Huntington Beach
country: United States
facility: GSK Investigational Site
state: California
city: Mission Viejo
country: United States
facility: GSK Investigational Site
state: California
city: Rolling Hills Estates
country: United States
facility: GSK Investigational Site
state: California
city: Stockton
country: United States
facility: GSK Investigational Site
state: California
city: Bethesda
country: United States
facility: GSK Investigational Site
state: Maryland
city: Bellevue
country: United States
facility: GSK Investigational Site
state: Nebraska
city: Skillman
country: United States
facility: GSK Investigational Site
state: New Jersey
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: GSK Investigational Site
state: Oklahoma
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Dallas
country: United States
facility: GSK Investigational Site
state: Texas
city: El Paso
country: United States
facility: GSK Investigational Site
state: Texas
city: San Antonio
country: United States
facility: GSK Investigational Site
state: Texas
city: Waco
country: United States
facility: GSK Investigational Site
state: Texas
city: South Burlington
country: United States
facility: GSK Investigational Site
state: Vermont
city: Greenfield
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Mannheim
country: Germany
facility: GSK Investigational Site
state: Baden-Wuerttemberg
city: Bad Woerrishofen
country: Germany
facility: GSK Investigational Site
state: Bayern
city: Potsdam
country: Germany
facility: GSK Investigational Site
state: Brandenburg
city: Offenbach
country: Germany
facility: GSK Investigational Site
state: Hessen
city: Dresden
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Leipzig
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Radebeul
country: Germany
facility: GSK Investigational Site
state: Sachsen
city: Reinfeld
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
city: Schmoelln
country: Germany
facility: GSK Investigational Site
state: Thueringen
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Berlin
country: Germany
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Bangkok
country: Thailand
facility: GSK Investigational Site
city: Chiangmai
country: Thailand
facility: GSK Investigational Site
city: Khon Kaen
country: Thailand
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: GSK Investigational Site
city: Donetsk
country: Ukraine
facility: GSK Investigational Site
city: Donetsk
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Kyiv
country: Ukraine
facility: GSK Investigational Site
city: Simferopol
country: Ukraine
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Busse WW, O'Byrne PM, Bleecker ER, Lotvall J, Woodcock A, Andersen L, Hicks W, Crawford J, Jacques L, Apoux L, Bateman ED. Safety and tolerability of the novel inhaled corticosteroid fluticasone furoate in combination with the beta2 agonist vilanterol administered once daily for 52 weeks in patients >=12 years old with asthma: a randomised trial. Thorax. 2013 Jun;68(6):513-20. doi: 10.1136/thoraxjnl-2012-202606. Epub 2013 Feb 25.