Last updated: 11/07/2018 04:29:34
Safety and Efficacy of GW685698X an inhaled corticosteroid once daily and twice daily for the treatment of asthma
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: The purpose of this study is to compare once and twice daily GW685698 in asthma
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
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:
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
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)
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)
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)
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)
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
Interventions:
Drug: GW685698X
Enrollment:
190
Observational study model:
Not applicable
Primary completion date:
2009-13-03
Time perspective:
Not applicable
Clinical publications:
Woodcock A, Bleecker ER, Busse WW, Lötvall 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;12:160.
Medical condition
Asthma
Product
fluticasone furoate, fluticasone propionate
Collaborators
Not applicable
Study date(s)
October 2008 to March 2009
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
- Clinical diagnosis of Asthma
- Reversibility ≥ 12% and ≥200mls reversibility of FEV1 within approximately 30-minutes following 2
- History of life threatening asthma
- Respiratory Infection or oropharyngeal candidiasis
Inclusion and exclusion criteria
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
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
Trial location(s)
Location
GSK Investigational Site
Long Beach, California, United States, 90806
Status
Study Complete
Location
GSK Investigational Site
Tallahassee, Florida, United States, 32308
Status
Study Complete
Location
GSK Investigational Site
Columbia, Missouri, United States, 65203
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
Location
GSK Investigational Site
Bethesda, Maryland, United States, 20814
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Torrance, California, United States, 90505
Status
Study Complete
Location
GSK Investigational Site
Long Beach, California, United States, 90808
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27607
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2009-13-03
Actual study completion date
2009-13-03
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Participate in clinical trial
Additional information
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Click hereAccess to clinical trial data by researchers
Visit website