Clinical trial NCT01348555: Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Pierre Fabre Medicament
Sponsor class: INDUSTRY
Collaborators: name: SGS Life Sciences, a division of SGS Belgium NV
First posted: 2011-05-05
Enrollment: 108
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pulmonary administered anticholinergic agents have shown their importance in the chronic obstructive pulmonary disease (COPD) management to reduce morbidity, disability and mortality. To date, the recommended treatment of moderate to severe COPD patients consist in the combination of ß2 agonist and long acting antimuscarinic compounds. There is still a medical need in new product that could exhibit both anti-inflammatory and strong bronchodilation potency. V0162 is a compound with a potent anticholinergic activity.

Secondary PD properties of V0162 could enhance the efficacy of this antimuscarinic compound and could bring new option in the treatment of this life-threatening disease.

Detailed description: This study has two parts. Part A will be conducted in 72 healthy volunteers. Part B will be conducted in 20 patients diagnosed with COPD.

Part A The primary objective of this part of the study is to assess the local tolerability of escalating doses of V0162 in male healthy volunteers.

Part B The primary objective of this part of the study is to assess the bronchodilator properties of V0162 at the maximal tolerated dose (determined in Part A) in COPD patients.

In addition, pharmacokinetics and vital sign including ECG will be determined.

Eligibility criteria: Inclusion Criteria Part A:

* Male gender
* Age between 18 to 50 years included,
* 18 ≤ Body Mass Index (BMI) \< 30 kg/m²,
* Who had given their written consent for their participation in the study,
* Who, in the judgement of the Investigator, are likely to be compliant during the study,
* Registered with a social security insurance system.

Inclusion Criteria Part B:

* Aged 40 to 65 years-old,
* 18 ≤ BMI \< 35 kg/m2,
* Smokers ≥ 10 packs / year,
* Moderate to severe COPD
* Registered with a social security insurance system.

Exclusion Criteria Part A:

* History of asthma or significant respiratory disorder,
* History of allergic rhinitis,
* Upper respiratory tract infection in the last month,
* Blood eosinophil count ≥ 600/μL,
* Epilepsy, narrow angle glaucoma, prostatic hypertrophy or bladder neck obstruction,
* Abnormal spirography,

Exclusion Criteria Part B:

* Respiratory tract infection in the last 6 weeks,
* Asthma or significant respiratory disorder other than COPD,
* Allergic rhinitis,
* Blood eosinophil count ≥ 600/μL,
* Epilepsy, narrow angle glaucoma, moderate to severe prostatic hypertrophy or bladder neckobstruction,
* Myocardial infarction within the previous 6 months, heart failure or serious cardiac arrhythmia,
* Moderate to severe renal impairment,
* Moderate to severe hepatic impairment
* Use of short-acting b-agonist,
* Use of anticholinergics

Primary outcomes:
measure: To assess the local tolerability of V0162 in healthy male volunteers
timeFrame: change from baseline in the local tolerability over 72 h after dosing
Secondary outcomes:
measure: To determine the PK parameters of V0162 in healthy male volunteers
timeFrame: 0, 5, 15, 30, 45 min, 1, 2, 4, 8, 12, 24, 48 and 72 h after dosing
measure: To assess the bronchodilator properties of V0162 in COPD
timeFrame: 0, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 14, 20, 24, 28 and 32 h after dosing
Other outcomes:
Locations:
city: Anvers
country: Belgium
facility: SGS
city: Paris
country: France
facility: SGS Aster SAS
Study officials:
References:
citation: Devillier P, Garrigue E, D'Auzers G, Monjotin N, Similowski T, Clerc T. V0162 a new long-acting bronchodilator for treatment of chronic obstructive lung diseases: preclinical and clinical results. Respir Res. 2015 Jun 8;16(1):68. doi: 10.1186/s12931-015-0227-1.