A Study of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.
A Randomised, Double-blind, Double Dummy, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of GW685698X 100mcg Administered Once Daily Either in the Morning or the Evening and GW685698X 250mcg Administered Once Daily in the Evening All Administered by Inhalation Via DISKHALER for 28 Days in Subjects With Persistent Bronchial Asthma.
1 other identifier
interventional
669
13 countries
64
Brief Summary
The purpose of this study is to compare the efficacy and safety of GW685698X 100mcg once daily either in the morning or the evening and GW685698X 250mcg administered once daily in the evening via DISKHALER for 28 days in subjects with persistent bronchial asthma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 asthma
Started Sep 2003
Shorter than P25 for phase_2 asthma
64 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
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
December 26, 2011
CompletedSeptember 15, 2016
September 1, 2016
6 months
December 8, 2011
September 13, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Peak expiratory flow (PEF)
Mean change from baseline in daily trough (pre study treatment and pre bronchodilator) PEF during the 28 day treatment period with GW685698X 100mcg once daily in the morning compared with GW685698X 100mcg once daily in the evening by inhalation via DISKHALER.
28 days
Secondary Outcomes (3)
Peak expiratory flow (PEF)
28 days
PEF
28 days
Clinic lung function
28 days
Study Arms (4)
GW685698X (fluticasone furoate) 100mcg Morning
EXPERIMENTALGW685698X (fluticasone furoate) 100mcg Evening
EXPERIMENTALGW685698X (fluticasone furoate) 250mcg Evening
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
Eligibility Criteria
You may qualify if:
- Outpatients aged between 16- 65 years.
- Male and female; female subjects must be non-child bearing potential or of childbearing potenetial with negative pregnancy test and willing to use acceptable contraceptive methods
- Documented clinical history of persistent asthma first diagnosed at least 6 months prior to Visit 1
- Currently receiving inhaled short-acting beta-2 agonists for symptom relief
- A lung function of between 50 to 90% predicted (PEF)
- Increase in PEF of at least15%, 20 minutes after inhalation of 400mcg salbutamol
You may not qualify if:
- History of respiratory tract infection and/or exacerbation of asthma within a period of 4 weeks prior to Visit 1
- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest or hypoxia seizures.
- A history of two or more asthma exacerbations requiring treatment with oral corticosteroids or hospitalisation in the 6 months before Visit 1.
- Past or present disease that, as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematologic disease, neurological disease, endocrine disease or pulmonary disease (including, but not confined to, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis and bronchopulmonary dysplasia).
- Known or suspected sensitivity to corticosteroids, VENTOLIN, or the constituents of ROTADISKS (e.g., lactose).
- Undergoing allergen desensitisation therapy.
- Neurological or psychiatric disease or history of drug or alcohol abuse that would interfere with the subject's proper completion of the protocol requirements.
- Is a current smoker or has a smoking history of 10 pack years or more (e.g., 20 cigarettes/day for 10 years). Note: Current smoker is defined as currently smoking or stopped smoking within 6 months of screening visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (64)
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 40110-160, Brazil
GSK Investigational Site
Pleven, 5800, Bulgaria
GSK Investigational Site
Sofia, 1431/1000, Bulgaria
GSK Investigational Site
Sofia, 1606, Bulgaria
GSK Investigational Site
Sofia, 1619, Bulgaria
GSK Investigational Site
Varna, 9010, Bulgaria
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500551, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500691, Chile
GSK Investigational Site
Osijek, 31000, Croatia
GSK Investigational Site
Split, 21000, Croatia
GSK Investigational Site
Zagreb, 10000, Croatia
GSK Investigational Site
Kohtal-Jdrve, 31 025, Estonia
GSK Investigational Site
Pärnu, 80024, Estonia
GSK Investigational Site
Tallinn, 1162, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Schwetzingen, Baden-Wurttemberg, 68723, Germany
GSK Investigational Site
Weinheim, Baden-Wurttemberg, 69469, Germany
GSK Investigational Site
Eschwege, Hesse, 37269, Germany
GSK Investigational Site
Gelnhausen, Hesse, 63571, Germany
GSK Investigational Site
Kassel, Hesse, 34117, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30159, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30167, Germany
GSK Investigational Site
Lüneburg, Lower Saxony, 21335, Germany
GSK Investigational Site
Gütersloh, North Rhine-Westphalia, 33330, Germany
GSK Investigational Site
Annaberg, Saxony, 09456, Germany
GSK Investigational Site
Aue, Saxony, 08280, Germany
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502, Germany
GSK Investigational Site
Berlin, State of Berlin, 10365, Germany
GSK Investigational Site
Berlin, State of Berlin, 10585, Germany
GSK Investigational Site
Berlin, State of Berlin, 10717, Germany
GSK Investigational Site
Berlin, State of Berlin, 10969, Germany
GSK Investigational Site
Berlin, State of Berlin, 13086, Germany
GSK Investigational Site
Berlin, State of Berlin, 13597, Germany
GSK Investigational Site
Erfurt, Thuringia, 99084, Germany
GSK Investigational Site
Athens, 115 28, Greece
GSK Investigational Site
Athens, 15669, Greece
GSK Investigational Site
Papagos/Athens, 15669, Greece
GSK Investigational Site
Törökbálint, 2045, Hungary
GSK Investigational Site
Eboli (SA), Campania, 84025, Italy
GSK Investigational Site
Napoli, Campania, 80131, Italy
GSK Investigational Site
Salerno, Campania, 84126, Italy
GSK Investigational Site
Ferrara, Emilia-Romagna, 44100, Italy
GSK Investigational Site
Genoa, Liguria, 16132, Italy
GSK Investigational Site
Sesto San Giovanni (MI), Lombardy, 20099, Italy
GSK Investigational Site
Torrette (AN), The Marches, 60126, Italy
GSK Investigational Site
Florence, Tuscany, 50134, Italy
GSK Investigational Site
Pisa, Tuscany, 56124, Italy
GSK Investigational Site
Bussolengo (VR), Veneto, 37012, Italy
GSK Investigational Site
Padua, Veneto, 35128, Italy
GSK Investigational Site
Mexico City, 06720, Mexico
GSK Investigational Site
México, 04530, Mexico
GSK Investigational Site
Brasov, Romania
GSK Investigational Site
Bucharest, 050159, Romania
GSK Investigational Site
Bucharest, 70000, Romania
GSK Investigational Site
Kazan', 420015, Russia
GSK Investigational Site
Moscow, 115446, Russia
GSK Investigational Site
Moscow, 115478, Russia
GSK Investigational Site
Moscow, 123 182, Russia
GSK Investigational Site
Saint Petersburg, 197 089, Russia
GSK Investigational Site
Saint Petersburg, 197022, Russia
GSK Investigational Site
Tomsk, 634 050, Russia
GSK Investigational Site
Volgograd, 400130, Russia
GSK Investigational Site
Bloemfontein, 9300, South Africa
GSK Investigational Site
Cape Town, 7500, South Africa
Related Publications (2)
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.
PMID: 27881132DERIVEDMedley H, Orozco S, Allen A. Efficacy and safety profile of fluticasone furoate administered once daily in the morning or evening: a randomized, double-blind, double-dummy, placebo-controlled trial in adult and adolescent patients with persistent bronchial asthma. Clin Ther. 2012 Aug;34(8):1683-95. doi: 10.1016/j.clinthera.2012.06.024. Epub 2012 Jul 13.
PMID: 22796247DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 8, 2011
First Posted
December 26, 2011
Study Start
September 1, 2003
Primary Completion
March 1, 2004
Study Completion
March 1, 2004
Last Updated
September 15, 2016
Record last verified: 2016-09
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.