NCT00671736

Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis

A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults With Cystic Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: AOP Orphan Pharmaceuticals AG · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a dose-finding study for the investigational product Lancovutide (Moli1901) in the exploratory phase IIb to establish minimum effective dose, optimal dose, and maximum safe dose. Additionally, the tolerability of Moli1901 shall be investigated.

Detailed description

Study Moli1901-010B is a multi center, parallel group, placebo controlled, double-blind efficacy and safety evaluation of three different dosage schedules of aerosolized Moli1901 in adolescents (12 years of age or older), and adults. Study will start with a screening period (visit 1) followed by an 8 weeks double blind comparative treatment period (visit 2-7). Thereafter, subjects will be observed for additional 4 weeks without treatment (follow-up period and visit 8). Spirometry, pulse oximetry and other safety measurements will be performed up to 120 min after study medication inhalation. The study will be conducted in 30 sites in 9 European countries.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Moli1901	2,5 ml inhalation solution, 8 weeks treatment period
DRUG	Moli1901 placebo	2,5 ml placebo solution, 8 weeks treatment period

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2008-05-05
• Last updated: 2009-08-27

Locations

1 site across 1 country: Austria