A Phase 1/2 interventional study of Bronchodilatator and Bronchodilatator in Chronic Obstructive Pulmonary Disease, sponsored by Pierre Fabre Medicament. Completed at 2 sites in 2 countries. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-04.
Sponsored by Pierre Fabre Medicament · Phase 1/2, Interventional, and Treatment
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.
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.
2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.
This study's enrollment of 108 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
Browse Lung Diseases, Obstructive studies →Pierre Fabre Medicament is the lead sponsor of 71 studies on the registry; 6 are open to participants now.
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Inclusion Criteria Part A:
Inclusion Criteria Part B:
Exclusion Criteria Part A:
Exclusion Criteria Part B:
Drug: Bronchodilatator
Drug: Bronchodilatator
To assess the local tolerability of V0162 in healthy male volunteers
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).
Time frame: change from baseline in the local tolerability over 72 h after dosing
To determine the PK parameters of V0162 in healthy male volunteers
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.
Time frame: 0, 5, 15, 30, 45 min, 1, 2, 4, 8, 12, 24, 48 and 72 h after dosing
To assess the bronchodilator properties of V0162 in COPD
Monitoring of parameters of the pulmonary function through plethysmography measurements.
Time frame: 0, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 14, 20, 24, 28 and 32 h after dosing
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Pierre Fabre Medicament