A Study to Evaluate the Effect of Fluticasone/Formoterol Breath Actuated Inhaler (BAI) or Relvar® Ellipta® DPI on Ventilation Heterogeneity in Asthma

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Fluticasone/Vilanterol DPI (Relvar Ellipta DPI); Drug: Fluticasone/Formoterol BAI

• Registration Number: NCT02753712
• Lead Sponsor: Mundipharma Research Limited

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-04-28
• Study Start: 2016-06-15
• Primary Completion: 2017-08-14
• Study Completion: 2017-08-14
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
fluticasone/vilanterol DPI (Relvar Ellipta DPI)	Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)	Inhalation powder. 92/22µg, I inhalation od
Fluticasone/formoterol BAI	Fluticasone/Formoterol BAI	Pressurised suspension for inhalation 125/5µg, 2 inhalations bid

Primary Outcome Measures

Name	Time	Method
Measuring peripheral airway resistance (R5-R20)	From baseline to week 8	Measuring peripheral airway resistance (R5-R20)

Secondary Outcome Measures

Name	Time	Method
Measuring distal airway volume and resistance (using impulse oscillometry)	From baseline to week 8 and 9	Measuring distal airway volume and resistance (using Functional Respiratory Imaging (FRI)
Evaluate asthma control (using ACQ-6) )	From baseline to week 4 and 8	Evaluate asthma control (using ACQ-6) )
Evaluate health status (using AQLQ)	From baseline to week 4 and 8	Evaluate health status (using AQLQ)
measure ventilation heterogeneity (using Functional Respiratory Imaging)	From baseline to week 9	measures of ventilation heterogeneity

Trial Locations

Locations (16)

Allergy immunology and Respiratory medicine, The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Epworth Eastern Medical Centre; 🇦🇺 Box Hill, Victoria, Australia

Otago Respiratory Research Unit; 🇳🇿 Dunedin, New Zealand

PULMO, s.r.o; 🇸🇰 Prešov, Slovakia

The Woolcock Institute of Medical Research; 🇦🇺 Glebe, New South Wales, Australia

INSPIRO, s.r.o. Ambulancia pneumológie a ftizeológie; 🇸🇰 Humenné, Slovakia

The New Zealand Respiratory and Sleep Institute; 🇳🇿 Greenlane, Auckland, New Zealand

DAMIZA, s.r.o. Ambulancia pneumológie a ftizeológie; 🇸🇰 Námestovo, Slovakia

Pľúcna ambulancia Hrebenár, s.r.o.; 🇸🇰 Spišská Nová Ves, Slovakia

Poliklinika ADUS, Pľúcna ambulancia; 🇸🇰 Poprad, Slovakia

Skane University Hospital; 🇸🇪 Lund, Sweden

ANA JJ, s.r.o, Ambulancia klinickej imunológie a alergológie; 🇸🇰 Topoľčany, Slovakia

Royal Brompton and Harefield Foundation Trust; 🇬🇧 London, United Kingdom

Respiratory Biomedical Research Unit, Glenfield Hospital; 🇬🇧 Leicester, Leicestershire, United Kingdom

Bradford Teaching Hospital; 🇬🇧 Bradford, United Kingdom

University Hospital of South Manchester; 🇬🇧 Manchester, United Kingdom