The Efficacy of Fluticasone Furoate/Vilanterol Versus (vs) Fluticasone Furoate on Asthma
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT03363191
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
The objective of this study is to evaluate fluticasone furoate/vilanterol compared with fluticasone furoate alone in subjects with asthma that is uncontrolled on low to mid dose inhaled corticosteroid (ICS) or low dose ICS/ long acting beta agonist (LABA) combination. This is a phase IV, randomized, double-blind, parallel group, multicenter study evaluating fluticasone furoate/vilanterol 100/25 micrograms (mcg) and fluticasone furoate 100 mcg once daily, delivered as an inhalation powder using the ELLIPTA® device in subjects with uncontrolled asthma despite daily ICS or ICS/LABA therapy. The study will measure treatment response and asthma control using the Asthma Control Questionnaire-7 (ACQ-7) focusing on symptomatic control. In this study, proportion of subjects with an improvement in ACQ-7 score of \>=0.5 at Week 12 compared to Baseline for the fluticasone furoate/vilanterol 100 mcg/25 mcg and fluticasone furoate100 mcg groups will be assessed. The total study duration for each subject will be 17 weeks including 4-week run in period, 12-week treatment period and 1-week follow up period. Approximately 1012 subjects will be randomized into the study. ELLIPTA is a registered trademark of GlaxoSmithKline group of companies.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Subjects received Fluticasone Furoate/Vilanterol Fluticasone Furoate/Vilanterol Subjects will receive fluticasone furoate/vilanterol 100/25 mcg inhalation powder via ELLIPTA dry powder inhaler (DPI) once daily for the 12 week treatment period. Subjects will receive salbutamol/albuterol as rescue medication on an as-needed basis. Subjects received Fluticasone Furoate/Vilanterol Salbutamol/Albuterol Subjects will receive fluticasone furoate/vilanterol 100/25 mcg inhalation powder via ELLIPTA dry powder inhaler (DPI) once daily for the 12 week treatment period. Subjects will receive salbutamol/albuterol as rescue medication on an as-needed basis. Subjects received Fluticasone Furoate Fluticasone Furoate Subjects will receive fluticasone furoate 100 mcg inhalation powder via ELLIPTA DPI once daily for the 12 week treatment period. Subjects will receive salbutamol/albuterol as rescue medication on an as-needed basis. Subjects received Fluticasone Furoate Salbutamol/Albuterol Subjects will receive fluticasone furoate 100 mcg inhalation powder via ELLIPTA DPI once daily for the 12 week treatment period. Subjects will receive salbutamol/albuterol as rescue medication on an as-needed basis.
- Primary Outcome Measures
Name Time Method Number of subjects with an improvement in ACQ-7 score of >= 0.5 at Week 12 compared to Baseline Baseline and at Week 12 The ACQ-7 consists of five questions about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) in the previous week, along with one question on daily bronchodilator use in the previous week, and a measure of lung function (forced expiratory volume in 1 second \[FEV1\] % predicted). The response options for all these questions consist of a zero (no impairment) to six (total impairment) scale. The questions are equally weighted, and the ACQ-7 score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A score \>= 1.5 indicates asthma that is not well controlled, while a mean score of \<= 0.75 indicates asthma that is well controlled, with a change of 0.5 defined as the minimal clinically important difference.
- Secondary Outcome Measures
Name Time Method Change from Baseline in the percentage of symptom-free night time periods during the 12-week treatment period Baseline and up to Week 12 Subjects will be issued an electronic diary for use during the study. Subjects will record night time asthma symptoms scores and the number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the night time periods. Symptoms and rescue use will be recorded between Visits 1 (Week-4) and 4 (Week 12), once in the morning (reporting night time symptoms) before taking any rescue medication or ICS.
Change from Baseline in the percentage of rescue-free daytime periods during the 12-week treatment period Baseline and up to Week 12 Subjects will be issued an electronic diary for use during the study. Subjects will record daytime asthma symptoms scores and the number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the daytime period. Symptoms and rescue use will be recorded between Visits 1 (Week-4) and 4 (Week 12), once in the evening (reporting daytime symptoms) before taking any rescue medication or ICS. Each evening, participants will record an asthma symptom score using the following scale: 1 = no symptoms during the day 2 = symptoms for one short period during the day 3 = symptoms for two or more short periods during the day 4 = symptoms for most of the day which did not affect my normal daily activities 5 = symptoms for most of the day which did affect my normal daily activities, 6 = symptoms so severe that I could not go to work or perform normal daily activities.
Change from Baseline in the percentage of symptom-free daytime periods during the 12-week treatment period Baseline and up to Week 12 Subjects will be issued an electronic diary for use during the study. Subjects will record daytime asthma symptoms scores and the number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the daytime period. Symptoms and rescue use will be recorded between Visits 1 (Week-4) and 4 (Week 12), once in the evening (reporting daytime symptoms) before taking any rescue medication or ICS.
Number of subjects with an ACQ-7 score <= 0.75 at Week 12 Baseline and at Week 12 The ACQ-7 consists of five questions about the frequency and/or severity of symptoms (nocturnal awakening on waking in the morning, activity limitation, and shortness of breath, wheeze) in the previous week, along with one question on daily bronchodilator use in the previous week, and a measure of lung function (FEV1 % predicted). The response options for all these questions consist of a zero (no impairment) to six (total impairment) scale. The questions are equally weighted, and the ACQ-7 score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). A score \>=1.5 indicates asthma that is not well-controlled, while a mean score of \<= 0.75 indicates asthma that is well-controlled, with a change of 0.5 defined as the minimal clinically important difference.
Change from Baseline in the percentage of rescue-free night time periods during the 12-week treatment period Baseline and up to Week 12 Subjects will be issued an electronic diary for use during the study. Subjects will record night time asthma symptoms scores and the number of inhalations of rescue albuterol/salbutamol inhalation aerosol used during the night time period. Symptoms and rescue use will be recorded twice a day between Visits 1 (Week-4) and 4 (Week 12), once in the morning (reporting night time symptoms) before taking any rescue medication or ICS. Each morning, subjects will record an asthma symptom score using the following scale: 1 = no symptoms during the night, 2 = symptoms causing me to wake once (or wake early), 3 = symptoms causing me to wake twice or more (including waking early), 4 = symptoms causing me to be awake for most of the night, and 5 = symptoms so severe that I did not sleep at all.