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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-000801-38 | EudraCT Number |
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The purpose of this study is to demonstrate improvement of peripheral airway resistance (R5-R20) from baseline with fluticasone/formoterol breath actuated inhaler (BAI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| fluticasone/vilanterol DPI (Relvar Ellipta DPI) | Active Comparator | Inhalation powder. 92/22µg, I inhalation od |
|
| Fluticasone/formoterol BAI | Experimental | Pressurised suspension for inhalation 125/5µg, 2 inhalations bid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluticasone/Formoterol BAI | Drug |
| ||
| Fluticasone/Vilanterol DPI (Relvar Ellipta DPI) |
| Measure | Description | Time Frame |
|---|---|---|
| Measuring peripheral airway resistance (R5-R20) | Measuring peripheral airway resistance (R5-R20) | From baseline to week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| measure ventilation heterogeneity (using Functional Respiratory Imaging) | measures of ventilation heterogeneity | From baseline to week 9 |
| Measuring distal airway volume and resistance (using impulse oscillometry) |
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Inclusion Criteria for subjects on Seretide Accuhaler 250/50 µg at screening:
Inclusion criteria for subjects on equivalent /higher dose or other ICS-LABAs or higher dose of Seretide at screening:
Male and female subjects ≥18 years old.
Adequate contraception
Documented clinical history of asthma for ≥6 months prior to screening visit
R5-R20 ≥0.07 kPa/L/s as measured on impulse oscillometry during the screening visit.
Exclusion Criteria for all subjects:
Exclusion Criteria for subset of subjects undergoing OR-MRI and HD-CT
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Woolcock Institute of Medical Research | Glebe | New South Wales | NSW 2037 | Australia | ||
| Epworth Eastern Medical Centre |
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| Label | URL |
|---|---|
| Link to Eu CT Register | View source |
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| Drug |
|
Measuring distal airway volume and resistance (using Functional Respiratory Imaging (FRI)
| From baseline to week 8 and 9 |
| Evaluate asthma control (using ACQ-6) ) | Evaluate asthma control (using ACQ-6) ) | From baseline to week 4 and 8 |
| Evaluate health status (using AQLQ) | Evaluate health status (using AQLQ) | From baseline to week 4 and 8 |
| Box Hill |
| Victoria |
| 3128 |
| Australia |
| Allergy immunology and Respiratory medicine, The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| The New Zealand Respiratory and Sleep Institute | Greenlane | Auckland | 1051 | New Zealand |
| Otago Respiratory Research Unit | Dunedin | 9016 | New Zealand |
| INSPIRO, s.r.o. Ambulancia pneumológie a ftizeológie | Humenné | 066 01 | Slovakia |
| DAMIZA, s.r.o. Ambulancia pneumológie a ftizeológie | Námestovo | 029 01 | Slovakia |
| Poliklinika ADUS, Pľúcna ambulancia | Poprad | 05801 | Slovakia |
| PULMO, s.r.o | Prešov | 080 01 | Slovakia |
| Pľúcna ambulancia Hrebenár, s.r.o. | Spišská Nová Ves | 052 01 | Slovakia |
| ANA JJ, s.r.o, Ambulancia klinickej imunológie a alergológie | Topoľčany | 955 01 | Slovakia |
| Skane University Hospital | Lund | 221 85 | Sweden |
| Respiratory Biomedical Research Unit, Glenfield Hospital | Leicester | Leicestershire | LE3 9QP | United Kingdom |
| Bradford Teaching Hospital | Bradford | BD9 6RJ | United Kingdom |
| Royal Brompton and Harefield Foundation Trust | London | SW3 6HP | United Kingdom |
| University Hospital of South Manchester | Manchester | M23 9QZ | United Kingdom |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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