Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Fluticasone Furoate/Umeclidinium/Vilanterol
Product Code: GW685698/GSK573719/GW642444
Pharmaceutical Form: Inhalation powder, pre-dispensed
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: AGE 1. 18 years of age or older at the time of signing the informed consent. TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY 2. Diagnosis: Subjects with a diagnosis of asthma as defined by the National Institutes of Health at least one year prior to Visit 0. 3. Symptomatic: Subjects with inadequately controlled asthma despite ICS/LABA maintenance therapy at Visit 1. 4. Asthma Control: A documented non-routine healthcare visit due to acute asthma symptoms in the 1 year prior to Visit 1. 5. Current Asthma Maintenance Therapy: Subjects are eligible if they have required daily ICS/LABA for at least 12 weeks prior to Visit 0 with no changes to maintenance asthma medications during the 6 weeks immediately prior to Visit 0 (including no changes to a stable total dose of ICS of >250 mcg/day fluticasone proprionate Examples of acceptable doses of commonly prescribed ICS and LABA or ICS/LABA combination medication is provided in the Study Reference Manual (SRM). Dosing regimen should be restricted to the current local product labels. 6. Spirometry: A best pre-bronchodilator morning FEV1 =30% and =65 years) yes F.1.3.1 Number of subjects for this age range 225
Exclusion criteria
Exclusion criteria: CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER FUNCTION AND QTc INTERVAL) 1. Pneumonia: Chest X-ray documented pneumonia in the 6 weeks prior to Visit 1. 2. Asthma Exacerbation: Any asthma exacerbation requiring a change in maintenance asthma therapy in the 6 weeks prior to Visit 1. Note: Subjects who experience an asthma exacerbation in the 6 weeks prior to Visit 1 are not explicitly excluded at Visit 1 provided that, at the Investigator’s discretion, the subject’s condition is stable and they are considered appropriate for enrolment into this study of up to 12 months’ duration. 3. Chronic Obstructive Pulmonary Disease: Subjects with the diagnosis of chronic obstructive pulmonary disease, as per Global Initiative for Chronic Obstructive Lung Disease guidelines, including all of the following: -History of exposure to risk factors; AND -A post-albuterol/salbutamol FEV1/Forced Vital Capacity ratio of 120 beats per minute (BPM); -Sustained or nonsustained ventricular tachycardia; -Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effects of FF/UMEC/VI on lung function compared with FF/VI after 24 weeks of treatment ; Secondary Objective: -To evaluate the efficacy of FF/UMEC/VI compared with FF/VI -To evaluate the safety of FF/UMEC/VI compared with FF/VI -To evaluate other efficacy assessments of FF/UMEC/VI compared with FF/VI ; Primary end point(s): Mean change from baseline in trough Forced Expiratory Volume in 1 second (FEV1) at Week 24 ;Timepoint(s) of evaluation of this end point: E.5.1.1. The primary analysis will be at 24 weeks. Data will be summarised at all timepoints where collected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -Annualized rate of moderate/severe asthma exacerbations -Mean change from baseline in clinic FEV1 at 3 hours post study treatment at Week 24 -Mean change from baseline in ACQ-7 total score at Week 24 -Mean change from baseline in St. George's Respiratory Questionnaire (SGRQ) total score at Week 24 -Mean change from baseline in Evaluating Respiratory Symptoms (E-RS) total score over the first 24 weeks of the treatment period -Incidence and type of adverse events (AEs) -Electrocardiogram (ECG) measurements -Vital signs -Clinical hematological and chemistry parameters ; Timepoint(s) of evaluation of this end point: E.5.2.1. For all endpoints except annualized rate of moderate/severe asthma exacerbations the primary analysis will be at week 24. For the annualized rate of moderate/severe asthma exacerbations endpoint all available data up until week 52 will be included in the primary analysis Data will be summarised for all end points at all timepoints where collected. | — |
Countries
Australia, Canada, Germany, Italy, Japan, Korea, Democratic People's Republic of, Netherlands, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research & Development Ltd
Outcome results
None listed