Safety and Efficacy of GW685698X an Inhaled Corticosteroid Once Daily and Twice Daily for the Treatment of Asthma
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
1 other identifier
interventional
190
1 country
16
Brief Summary
The purpose of this study is to compare once and twice daily GW685698 in asthma
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Oct 2008
Shorter than P25 for phase_2 asthma
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 2, 2008
CompletedFirst Posted
Study publicly available on registry
October 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
August 7, 2013
CompletedDecember 8, 2016
October 1, 2016
5 months
October 2, 2008
June 6, 2013
October 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Trough Forced Expiratory Volume in One Second (FEV1) at Day 28 of the Relevant Treatment Period
Pulmonary function was measured by FEV1, defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically by spirometry. Trough FEV1 was the evening pre-dose, pre-rescue bronchodilator FEV1 measurement taken on Day 28 of the relevant treatment period. The analysis was performed using mixed model analysis of covarience (ANCOVA) with fixed effects of treatment, period, sex, and age. Participants were fitted as a random effect, and the period Baseline measurement was included as part of a bivariate response.
Day 28 of the relevant treatment period (up to Study Day 112)
Secondary Outcomes (6)
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Three 28-day Treatment Periods
From the first dose of the study medication up to Week 16/Early Withdrawal
24-hour Urinary Cortisol Excretion at Day 28 of the Relevant Treatment Period
Day 28 of the relevant treatment period (up to Study Day 112)
Number of Participants With Evidence of Oropharyngeal Candidiasis at Day 0 and Day 28 of the Relevant Treatment Period
Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Systolic and Diastolic Blood Pressure at Day 0 and Day 28 of the Relevant Treatment Period
Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
Heart Rate at Day 0 and Day 28 of the Relevant Treatment Period
Day 0 and Day 28 of the relevant treatment period (up to Study Day 112)
- +1 more secondary outcomes
Study Arms (1)
GW685698X
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (16)
GSK Investigational Site
Long Beach, California, 90806, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Torrance, California, 90505, United States
GSK Investigational Site
Cocoa, Florida, 32927, United States
GSK Investigational Site
Tallahassee, Florida, 32308, United States
GSK Investigational Site
Bethesda, Maryland, 20814, United States
GSK Investigational Site
Columbia, Missouri, 65203, United States
GSK Investigational Site
Rolla, Missouri, 65401, United States
GSK Investigational Site
Raleigh, North Carolina, 27607, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Orangeburg, South Carolina, 29118, United States
GSK Investigational Site
Austin, Texas, 78750, United States
GSK Investigational Site
Boerne, Texas, 78006, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Waco, Texas, 76712, United States
Related Publications (2)
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.
PMID: 22188590BACKGROUNDO'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.
PMID: 27881132DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 2, 2008
First Posted
October 3, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
December 8, 2016
Results First Posted
August 7, 2013
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.