Clinical trial NCT00766090: Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma
Official title: A Multi-Centre, Randomized, Double Blind Cross-over Study to Assess the Non-inferiority of GW685698X 200mcg Once Daily and 100mcg Twice Daily in Adult and Adolescent Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 190
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare once and twice daily GW685698 in asthma


Eligibility criteria: Key Inclusion Criteria:

* Clinical diagnosis of Asthma
* Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2 to 4 puffs of albuterol
* FEV1 between 40-85% predicted
* Currently on short acting beta2 agonist therapy

Key Exclusion Criteria:

* History of life threatening asthma
* Respiratory Infection or oropharyngeal candidiasis
* Asthma exacerbation
* Uncontrolled disease or clinical abnormality
* Allergies
* Taking another Investigational medications or other prohibited medications

Primary outcomes:
measure: Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period
timeFrame: Day 28 of the relevant treatment period (up to Study Day 112)
Secondary outcomes:
measure: Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods
timeFrame: From the first dose of the study medication up to Week 16/Early Withdrawal
measure: 24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period
timeFrame: Day 28 of the relevant treatment period (up to Study Day 112)
measure: Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period
timeFrame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
measure: Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period
timeFrame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
measure: Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period
timeFrame: Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
measure: Number of Participants Who Withdrew Due to Worsening of Asthma During the Three Treatment Periods
timeFrame: From the first dose of the study medication up to Week 16/Early Withdrawal
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Long Beach
country: United States
facility: GSK Investigational Site
state: California
city: Torrance
country: United States
facility: GSK Investigational Site
state: California
city: Cocoa
country: United States
facility: GSK Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: GSK Investigational Site
state: Florida
city: Bethesda
country: United States
facility: GSK Investigational Site
state: Maryland
city: Columbia
country: United States
facility: GSK Investigational Site
state: Missouri
city: Rolla
country: United States
facility: GSK Investigational Site
state: Missouri
city: Raleigh
country: United States
facility: GSK Investigational Site
state: North Carolina
city: Canton
country: United States
facility: GSK Investigational Site
state: Ohio
city: Medford
country: United States
facility: GSK Investigational Site
state: Oregon
city: Orangeburg
country: United States
facility: GSK Investigational Site
state: South Carolina
city: Austin
country: United States
facility: GSK Investigational Site
state: Texas
city: Boerne
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
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Woodcock A, Bleecker ER, Busse WW, Lotvall J, Snowise NG, Frith L, Jacques L, Haumann B, Bateman ED. Fluticasone furoate: once-daily evening treatment versus twice-daily treatment in moderate asthma. Respir Res. 2011 Dec 21;12(1):160. doi: 10.1186/1465-9921-12-160.
citation: O'Byrne PM, Jacques L, Goldfrad C, Kwon N, Perrio M, Yates LJ, Busse WW. Integrated safety and efficacy analysis of once-daily fluticasone furoate for the treatment of asthma. Respir Res. 2016 Nov 24;17(1):157. doi: 10.1186/s12931-016-0473-x.