Bronchodilator Properties and Safety of a Repeated Dose of V0162 in Asthma.

Pierre Fabre Medicament1 site in 1 country59 target enrollmentSeptember 2013

ConditionsAsthma

InterventionsV0162 Placebo

DrugsV0162

Overview

Phase: Phase 2
Intervention: V0162
Conditions: Asthma
Sponsor: Pierre Fabre Medicament
Enrollment: 59
Locations: 1
Primary Endpoint: Normalised AUC 0-24h of FEV1 at day 8 of treatment period
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

September 2013

End Date

April 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Pierre Fabre Medicament

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 18 to 65 years-old.
•18 ≤ BMI \<30 kg/m².
•Clinical history consistent asthma, in the judgement of the investigator.
•Asthma controlled or partly controlled according to GINA 2012 criteria:
•Asthma treated by ICS and LABA (fixed-dose combination or free combination) at stable dose for at least 3 months.
•Able to replace the usual ICS and LABA therapy by ICS at the usual dose regimen and salbutamol as needed.
•Able to stop salbutamol at least 6 hours before a study visit.
•Able to perform at least 3 acceptable and reproducible FEV1 and FVC measurements according to ERS/ATS 2005 recommendations.

Exclusion Criteria

•Clinically significant respiratory conditions other than asthma (e.g. pneumonia, pneumothorax, atelectasis, bronchiectasis, chronic bronchitis, COPD, emphysema, pulmonary arterial hypertension, pulmonary fibrosis,etc.).
•Upper or lower respiratory tract infection within 4 weeks.
•Exacerbation (requiring oral corticosteroids or hospitalization) within 3 months.
•Current smoker or former smoker less than 6 months or total lifetime smoking history greater than 10 pack-years.
•Intolerance to salbutamol.
•Intolerance to tiotropium (or any other atropine-derived compound).
•Intolerance to one of the ingredients of the study product
•Severe hepatic impairment, moderate to severe renal impairment, epilepsy, narrow angle glaucoma, gastrointestinal obstruction, moderate to severe prostatic hypertrophy, bladder neck obstruction.
•Any acute or chronic disease that will not allow the participation in the study, in the judgement of the investigator.
•Clinically relevant physical examination abnormality.

Arms & Interventions

V0162 dose1

Intervention: V0162

V0162 dose2

Intervention: V0162

placebo

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)
AEs(From Visit 1 to Visit 11)
Difference between day 8 and first day of treatment period in normalised AUC 0-24h of FEV1(Difference between day 8 and first day of treatement period)
PEF(Morning and evening from 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)
Parameters of the pulmonary function(Day 1 and Day 8 of treatment period)
Clinical laboratory tests (haematology, biochemistry, urinalysis)(Visit 1 and Visit 11)
Normalised AUC 0-24h of FEV1 at Day 1 of treatment period(The first day of treatment period)
Dyspnoea(Day 1 to Day 8 of treatment period)