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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-022615-19 | EudraCT Number |
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The purpose of this study is to evaluate, at steady-state, the systemic exposure and the lung deposition of B17MP (active metabolite of BDP) as AUC0-12h,ss and Cmax,ss, after inhalation of BDP (Clenil® Modulite®) with the AeroChamber Plus™ spacer device or with the Volumatic™ spacer device without or with charcoal block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clenil® Modulite® via AeroChamber Plus™ | Experimental | Clenil® Modulite® administered via AeroChamber Plus™ spacer |
|
| Clenil® Modulite® via Volumatic™ | Active Comparator | Clenil® Modulite® administered via Volumatic™ spacer |
|
| Clenil® Modulite® via AeroChamber Plus™ plus charcoal block | Experimental | Clenil® Modulite® administered via AeroChamber Plus™ spacer plus charcoal block |
|
| Clenil® Modulite® via Volumatic™ plus charcoal block | Active Comparator | Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clenil® Modulite® via AeroChamber Plus™ | Drug | Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite® | Plasma AUC0-12h,ss for B17MP | 0-12 hours |
| Systemic exposure to B17MP (active metabolite of BDP) at steady state after repeated dose of Clenil® Modulite® | Plasma Cmax,ss for B17MP | 0-12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of the pharmacokinetic profile of BDP | AUC and Cmax for BDP | 0-12 hours |
| Vital signs assessment | Heart rate and Blood pressure assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dave Singh, MD | Medicine Evaluation Unit, Manchester, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicines Evaluation Unit, Wythenshawe Hospital | Manchester | United Kingdom |
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| Label | URL |
|---|---|
| Study Record on EU Clinical Trials Register including results | View source |
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| Clenil® Modulite® via Volumatic™ spacer | Drug | Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days |
|
| Clenil® Modulite® via AeroChamber Plus™ plus charcoal block | Drug | Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14) |
|
| Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block | Drug | Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14) |
|
| from screening (week -1) to week 8 |
| haematology and blood chemistry assessment | haematology and blood chemistry assessment | at screening (week - 1) and week 8 |
| Number of patients with Adverse events | Adverse events | during the 11 weeks of study |
| FEV1 predose assessment | FEV1 predose assessment as lung function parameter | from screening (week-1) to week 8 |
| 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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