Clinical trial NCT01951222: Bronchodilator Properties and Safety in Asthma
Official title: Bronchodilator Properties and Safety of a Repeated Dose of V0162 in Asthma.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma, COPD, broncodilator, airway, lung, inhalation, antimuscarinic
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
First posted: 2013-09-26
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Normalised AUC 0-24h of FEV1 at day 8 of treatment period
timeFrame: At the 8th day of treatment period
Secondary outcomes:
measure: Parameters of the pulmonary function
timeFrame: Day 1 and Day 8 of treatment period
measure: PEF
timeFrame: Morning and evening from Day 1 to day 8 of treatment period
measure: Dyspnoea
timeFrame: Day 1 to Day 8 of treatment period
measure: Vital signs
timeFrame: 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
measure: 12-lead standard ECG
timeFrame: 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
measure: Holter-ECG
timeFrame: At Visit 3 to Visit 10 : from 30 min pre-dose to 12 hours post-dose
measure: Clinical laboratory tests (haematology, biochemistry, urinalysis)
timeFrame: Visit 1 and Visit 11
measure: AEs
timeFrame: From Visit 1 to Visit 11
measure: Normalised AUC 0-24h of FEV1 at Day 1 of treatment period
timeFrame: The first day of treatment period
measure: Difference between day 8 and first day of treatment period in normalised AUC 0-24h of FEV1
timeFrame: Difference between day 8 and first day of treatement period
Other outcomes:
Locations:
city: Gauting
country: Germany
facility: CRO
Study officials:
References: