NCT02753712
Completed
Phase 3
A Two-arm, Randomised, Assessor-blind, Parallel Group Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) and Relvar® Ellipta® DPI on Ventilation Heterogeneity in Subjects With Partially Controlled or Uncontrolled Asthma
ConditionsAsthma
Overview
- Phase
- Phase 3
- Intervention
- Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)
- Conditions
- Asthma
- Sponsor
- Mundipharma Research Limited
- Enrollment
- 105
- Locations
- 16
- Primary Endpoint
- Measuring peripheral airway resistance (R5-R20)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
The purpose of this study is to demonstrate improvement of peripheral airway resistance (R5-R20) from baseline with fluticasone/formoterol breath actuated inhaler (BAI).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
fluticasone/vilanterol DPI (Relvar Ellipta DPI)
Inhalation powder. 92/22µg, I inhalation od
Intervention: Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)
Fluticasone/formoterol BAI
Pressurised suspension for inhalation 125/5µg, 2 inhalations bid
Intervention: Fluticasone/Formoterol BAI
Outcomes
Primary Outcomes
Measuring peripheral airway resistance (R5-R20)
Time Frame: From baseline to week 8
Measuring peripheral airway resistance (R5-R20)
Secondary Outcomes
- Measuring distal airway volume and resistance (using impulse oscillometry)(From baseline to week 8 and 9)
- Evaluate asthma control (using ACQ-6) )(From baseline to week 4 and 8)
- Evaluate health status (using AQLQ)(From baseline to week 4 and 8)
- measure ventilation heterogeneity (using Functional Respiratory Imaging)(From baseline to week 9)
Study Sites (16)
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