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| ID | Type | Description | Link |
|---|---|---|---|
| Eudract number: 2008-002391-97 |
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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate on central and peripheral airway dimensions in asthmatic patients using Computational Fluid Dynamics (CFD). Further more, the effect of this combination therapy on exhaled NO, lung function (spirometry, body plethysmography, diffusion and resistance) and subjective asthma control score as well as the safety of this combination will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inuvair | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inuvair | Drug | 6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in airway dimension | The primary objective of this study is to evaluate the effect of the combination therapy on central and peripheral airway dimensions with CFD. The following primary outcome parameters will be determined:
| airway dimension will be measured at visit 2 and visit 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Lung function tests: dynamic lung volumes, static lung volumes and airway resistances | The secondary outcome parameters that will be obtained with the lung function tests are:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wilfried A De Backer, MD, PhD | University Hospital, Antwerp | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Antwerp | Antwerp | 2650 | Belgium |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| lung function tests will be perfomed at te following visits: screening, visit 1 (2 weeks after screening), visit 3 (6 weeks after screening), visit 5 (14 weeks after screening) and visit 7 (26 weeks after screening) |
| Subjective asthma control score | Asthma control scores will be obtained with the Dutch Asthma Control Test. | Asthma Control Test (ACT) will be performed on visit 1, 2, 3, 5 and 7 |
| Exhaled Nitric Oxide (NO) | Exhaled NO will be measured on visit 2, 3, 5 and 7 |
| Adverse events as a measure of safety | Follow up of adverse events will be done during the entire study duration |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |