Last updated: 11/07/2018 09:59:52
Evaluate the safety, efficacy and dose response of GSK573719 in combination with Fluticasone Furoate in subjects with asthmaILA115938
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multi-center, randomized, double-blind, dose-ranging study to evaluate GSK573719 in combination with fluticasone furoate, fluticasone furoate alone, and an active control of fluticasone furoate/vilanterol combination in subjects with asthma
Trial description: Brief Summary: The purpose of this study is to characterize the dose response of GSK573719 in combination with Fluticasone furoate 100mcg in patients with asthma. Treatment with inhaled Fluticasone furoate and Fluticasone furoate/Vilanterol are included as an active control. Detailed Description: Long acting muscarinic receptor antagonists (anti-cholinergic bronhcodilator) exert their effects via distinct and complementary bronchodilator mechanisms on large and small airways. Most of the experience with older anti-cholinergics had been with acute use and little is known about their effect in chronic use in asthma. This is a multicenter, randomized, double-blind, crossover study to evaluate 5 doses of inhaled GSK573719 inhaled over 14 days in patients with asthma. Fluticasone furoate (100 mcg) and Fluticasone furoate/Vilanterol (100/59mcg) will be included as an active comparator. Each eligible subject will receive a sequence of 3 of 7 potential treatments for a total of 3 treatment periods per subject. The total duration of subject participation is approximately 14 weeks.
Primary purpose:
Diagnostic
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Model predicted change from baseline trough force expiratory volume in 1 second (FEV1)
Timeframe: Baseline (Day 1) and Day 15 of each treatment period
Percentage of chance that FF 100 mcg alone corrected change from baseline FEV1 response would exceed a target response by dose of UMEC combined with FF 100 mcg
Timeframe: Baseline (Day 1) and Day 15 of each treatment period
Mean change from baseline in trough FEV1 on Day 15 of each of the 3 treatment periods
Timeframe: Baseline (Day 1) and Day 15 of each treatment period
Secondary outcomes:
Mean change from baseline in daily morning (pre-dose and pre-rescue bronchodilator) peak expiratory flow (PEF) of each treatment period
Timeframe: Baseline (Week 0) and last 7 days of each treatment period
Mean change from baseline in daily evening (pre-dose and pre-rescue bronchodilator) PEF of each treatment period
Timeframe: Baseline (Week 0) and last 7 days of each treatment period
Mean change from baseline in rescue albuterol/salbutamol use of each treatment period.
Timeframe: Baseline (Week 0) and last 7 days of each treatment period
Interventions:
Drug: FF/GSK573719
Drug: FF
Drug: FF/VI
Enrollment:
421
Observational study model:
Not applicable
Primary completion date:
2013-04-02
Time perspective:
Not applicable
Clinical publications:
Laurie A. Lee, Shuying Yang, Edward Kerwin, Roopa Trivedi, Lisa D. Edwards, Steven Pascoe.The effect of fluticasone furoate/umeclidinium in adult patients with asthma: A randomized, dose-ranging study.Respir Med.2015;109(1):54-62
Medical condition
Asthma
Product
fluticasone furoate, fluticasone furoate/umeclidinium bromide, fluticasone furoate/vilanterol, umeclidinium bromide
Collaborators
Not applicable
Study date(s)
April 2012 to February 2013
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Outpatient
- 18 years of age or older at Visit 1
- History of Life threatening asthma
- Respiratory infection not resolved
Inclusion and exclusion criteria
Inclusion criteria:
- Outpatient
- 18 years of age or older at Visit 1
- Diagnosis of Asthma
- Male or eligible Female
- Pre-bronchodilator FEV1 of 40-80% of the predicted normal value at Visit 1
- Demonstrated reversibility by ≥12% and ≥200mL of FEV1 within 40 minutes following albuterol at Visit 1
- A need for regular controller therapy (i.e., inhaled corticosteroids alone or in combination with a long‐acting beta‐agonist, or leukotriene modifier etc.,) for a minimum of 8 weeks prior to Visit 1.
Exclusion criteria:
- History of Life threatening asthma
- Respiratory infection not resolved
- Asthma exacerbation -Concurrent respiratory disease -Current Smokers -Other diseases that are uncontrolled disease or disease state that, in the opinion of the investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study -A positive Hepatitis B surface antigen or positive Hepatitis C antibody and/or HIV -Visual clinical evidence of oropharyngeal candidiasis -Drug or milk protein allergies -Concomitant medications affecting course of asthma -Use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer) -Previous use of GSK573719 -Any disease preventing use of anticholinergics -Any condition that impairs compliance with study protocol including visit schedule and completion of daily diaries -Any subject with a history of alcohol or substance abuse -Any affiliation with Investigator’s site
Trial location(s)
Location
GSK Investigational Site
Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 7500551
Status
Study Complete
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Argentina, C1425BEN
Status
Study Complete
Location
GSK Investigational Site
Santiago, Región Metro De Santiago, Chile, 8880465
Status
Study Complete
Location
GSK Investigational Site
Orangeburg, South Carolina, United States, 29118
Status
Study Complete
Location
GSK Investigational Site
Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
Status
Study Complete
Location
GSK Investigational Site
Talca, Región Metro De Santiago, Chile, 3460001
Status
Study Complete
Location
GSK Investigational Site
St. Louis, Missouri, United States, 63141
Status
Study Complete
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Location
GSK Investigational Site
Buenos Aires, Buenos Aires, Argentina, C1424BSF
Status
Study Complete
Location
GSK Investigational Site
Valparaiso, Valparaíso, Chile, 2341131
Status
Study Complete
Location
GSK Investigational Site
San Miguel de Tucumán, Argentina, 4000
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
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
2013-04-02
Actual study completion date
2013-04-02
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.
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