Bronchodilator Properties and Safety in Asthma
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|ClinicalTrials.gov Identifier: NCT01951222|
Recruitment Status : Completed
First Posted : September 26, 2013
Last Update Posted : September 17, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: V0162 Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Bronchodilator Properties and Safety of a Repeated Dose of V0162 in Asthma.|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
|Experimental: V0162 dose1||
|Experimental: V0162 dose2||
Placebo Comparator: placebo
- Normalised AUC 0-24h of FEV1 at day 8 of treatment period [ Time Frame: At the 8th day of treatment period ]FEV1 assessed by spirometry
- Parameters of the pulmonary function [ Time Frame: Day 1 and Day 8 of treatment period ]
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:
- the normalised AUC0-9h of FEV1 (L),
- the normalised AUC0-12h of FEV1 (L),
- the peak of FEV1 (L) which is the higher observed post-dosing value,
- the trough of FEV1 (L) which is the last measurement before the next dosing (i.e. t24h),
- the normalised AUC0-9h,AUC0-12h, AUC0-24h, peak and trough of FVC, MEF25, MEF50, MEF75, and MEF25-75.
- PEF [ Time Frame: Morning and evening from Day 1 to day 8 of treatment period ]PEF measured using a peak-flow meter
- Dyspnoea [ Time Frame: Day 1 to Day 8 of treatment period ]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.
- Vital signs [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At Visit 3 to Visit 10 : from 30 min pre-dose to 12 hours post-dose ]
- Clinical laboratory tests (haematology, biochemistry, urinalysis) [ Time Frame: Visit 1 and Visit 11 ]
- AEs [ Time Frame: From Visit 1 to Visit 11 ]
- Normalised AUC 0-24h of FEV1 at Day 1 of treatment period [ Time Frame: The first day of treatment period ]FEV1 assessed by spirometry
- Difference between day 8 and first day of treatment period in normalised AUC 0-24h of FEV1 [ Time Frame: Difference between day 8 and first day of treatement period ]FEV1 assessed by spirometry
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951222