drugset / Trial / NCT01348555
Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162
Phase 1/2
Completed
108 enrolled
Pierre Fabre Laboratories
SGS Life Sciences, a division of SGS Belgium NV · collab
RandomizedCrossoverQuadruple-blindTreatment
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.
Timeline
- Start
- 2011-04
- Primary completion
- 2012-07
- Completion
- 2012-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | V0162 | Unknown | 1600 ug | Inhaled |
| Subject | V0162 | Unknown | 2400 ug | Inhaled |