Status:
COMPLETED
Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis
Lead Sponsor:
AOP Orphan Pharmaceuticals AG
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief 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,...
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 ye...
Eligibility Criteria
Inclusion
- Body mass index
- Confirmed diagnosis of cystic fibrosis
- FEV1 between 50% and 85% of predicted
- Oxygen saturation level measured by pulse oximetry (SpO2) \>90 % on room air
Exclusion
- Bronchial hyperresponsiveness
- Unstable lung function
- Pulmonary disease such as pneumonia, tuberculosis, or lung cancer
- Acute upper respiratory tract infection within the last 2 weeks
- Acute lower respiratory tract infection (requiring antibiotics or hospitalization) within the last 4 weeks
- Pulmonary exacerbation within the last 4 weeks
- Changes from routine maintenance therapy within the last 4 weeks
- Scheduled changes to inhaled antibiotics regimen during the course of the study
- Receive or are planned to receive any treatment via "on-off" regimen (e.g. Tobramycin - TOBI®); last dose of any "on-off" treatment within the last 6 weeks
- Any clinically significant liver, renal, cardiac, neurological, or hematological disease
- ABPA or colonization with Burkholderia cepacia
- Poorly controlled diabetes mellitus
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2009
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00671736
Start Date
October 1 2007
End Date
July 1 2009
Last Update
August 27 2009
Active Locations (1)
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1
Medical University
Graz, Austria, 8086