Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recent large clinical studies have demonstrated the interest of LAMA therapy in the management of asthma, when compared to LABA.
V0162 is a compound with a very long lasting bronchodilator effect when compared to reference treatment in non-clinical models and in COPD patients. Secondary properties of V0162 (i.e.H1/H4 and PDE IV-inhibition) could enhance the efficacy of this antimuscarinic compound and could bring option in the treatment obstructive lung disease. The objective of the study is to assess the bronchodilator properties of V0162 during 8 days in adult patients with asthma usually treated with ICS and LABA. The study is a randomised, double-blind, placebo-controlled, 3-period crossover, preceded by an open-label active-control period before randomisation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V0162 dose1 | Experimental |
| |
| V0162 dose2 | Experimental |
| |
| placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V0162 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Normalised AUC 0-24h of FEV1 at day 8 of treatment period | FEV1 assessed by spirometry | At the 8th day of treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Parameters of the pulmonary function | as well as the following criteria assessed the first day and the last day of each treatment period and the difference between the last day and the first day within each treatment periodadjusted for placebo effect:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRO | Gauting | Germany |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Day 1 and Day 8 of treatment period |
| PEF | PEF measured using a peak-flow meter | Morning and evening from Day 1 to day 8 of treatment period |
| Dyspnoea | The criteria will be the normalised AUC0-9h,AUC0-12h, and AUC0-24h of the dyspnoea measurements(mm) assessed the first and the last day of each treatment period, and the difference between the last and the first day within each treatment period. | Day 1 to Day 8 of treatment period |
| Vital signs | Visit 2, and at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 30 min, 1 h, 2 h, 4 h, 6 h, 8 h, 24 h post-dose during the in-clinic visits) and at Visit 11 |
| 12-lead standard ECG | at Visit 1, at Visit 3 to Visit 10 (within 30 min pre-dose and 15 min, 1 h, 6 h, 24 h post-dose) and at Visit 11 |
| Holter-ECG | At Visit 3 to Visit 10 : from 30 min pre-dose to 12 hours post-dose |
| Clinical laboratory tests (haematology, biochemistry, urinalysis) | Visit 1 and Visit 11 |
| AEs | From Visit 1 to Visit 11 |
| Normalised AUC 0-24h of FEV1 at Day 1 of treatment period | FEV1 assessed by spirometry | The first day of treatment period |
| Difference between day 8 and first day of treatment period in normalised AUC 0-24h of FEV1 | FEV1 assessed by spirometry | Difference between day 8 and first day of treatement period |
| 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 |
| D012120 | Respiration Disorders |