Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD
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.
Interventions
DRUGBronchodilatator
Sponsors
SGS Life Sciences, a division of SGS Belgium NV
Pierre Fabre Medicament
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the local tolerability of V0162 in healthy male volunteers | change from baseline in the local tolerability over 72 h after dosing | Monitoring of parameters of the pulmonary function: spirometry measurements. Assessment of respiratory system symptoms: using a 4-point scale and assessment of dyspnoea by VAS. Monitoring for the occurrence of AEs. Changes in physical examination: vital signs (blood pressure and pulse rate), holter-ECG and clinical laboratory tests (biochemistry, haematology, urinalysis). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the PK parameters of V0162 in healthy male volunteers | 0, 5, 15, 30, 45 min, 1, 2, 4, 8, 12, 24, 48 and 72 h after dosing | Pharmacokinetics: evaluation of the PK parameter of V0162 (measured by area under the plasma concentration-time curve (AUC)) after oral administration and of the dose proportionality. |
| To assess the bronchodilator properties of V0162 in COPD | 0, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 14, 20, 24, 28 and 32 h after dosing | Monitoring of parameters of the pulmonary function through plethysmography measurements. |
Countries
Belgium, France
Outcome results
None listed