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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-013759-32 | EudraCT Number |
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Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma
A randomised, double-blind, multinational, multicentre, active-controlled, 3-way cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with moderate or severe persistent asthma
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHF 5188 pMDI | Experimental |
| |
| Budesonide extrafine pMDI | Active Comparator |
| |
| Seretide(r) Evohaler(r) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHF 5188 pMDI | Drug | CHF 5188: fixed combination budesonide/carmoterol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 (mean 23h-24h FEV1) | after day 28 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h) | after day 1 dose | |
| Trough FVC (mean 23-24h) | after day 28 dose | |
| Peak FEV1 and FVC |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dave Singh, MD | The Medicines Evaluation Unit Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Medicines Evaluation Unit Ltd, The Langley Building, Southmoor Road | Manchester | M23 9QZ | United Kingdom |
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| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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| Budesonide extrafine pMDI |
| Drug |
Budesonide extrafine pMDI |
|
| Seretide(r) Evohaler(r) | Drug | Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol |
|
| on day 1 and day 28 |
| FEV1 AUC0-24 | after day 1 and day 28 |
| ID | Term |
|---|---|
| D001249 | Asthma |
| 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 |
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