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

This study has been completed.
Sponsor:
Information provided by:
AOP Orphan Pharmaceuticals AG
ClinicalTrials.gov Identifier:
NCT00671736
First received: April 30, 2008
Last updated: August 26, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Drug: Moli1901
Drug: Moli1901 placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AOP Orphan Pharmaceuticals AG:

Primary Outcome Measures:
  • The change in the percentage of the predicted FEV1 (forced expiratory volume in first second) value [ Time Frame: at every study visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The ensemble of two subject reported clinical scores, which are physical dimensions of the self-report, disease-specific quality of life test, the cystic fibrosis questionnaire in the revised version [ Time Frame: every 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: October 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
daily inhalation
Drug: Moli1901
2,5 ml inhalation solution, 8 weeks treatment period
Other Name: Lancovutide, 2622U90, duramycin
Experimental: 2
inhalation every other day
Drug: Moli1901
2,5 ml inhalation solution, 8 weeks treatment period
Other Name: Lancovutide, 2622U90, duramycin
Experimental: 3
inhalation twice a week
Drug: Moli1901
2,5 ml inhalation solution, 8 weeks treatment period
Other Name: Lancovutide, 2622U90, duramycin
Placebo Comparator: 4
daily inhalation
Drug: Moli1901 placebo
2,5 ml placebo solution, 8 weeks treatment period

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671736

Locations
Austria
Medical University
Graz, Austria, 8086
Sponsors and Collaborators
AOP Orphan Pharmaceuticals AG
Investigators
Principal Investigator: Ernst Eber, Prof Dr Medical University of Graz
  More Information

Additional Information:
Publications:
Responsible Party: Nina Vartyan-Böhm, PhD, AOP Orphan Pharmaceuticals AG
ClinicalTrials.gov Identifier: NCT00671736     History of Changes
Other Study ID Numbers: Moli1901-010B, EudraCT No 2006-006693-24
Study First Received: April 30, 2008
Last Updated: August 26, 2009
Health Authority: Austria: Agency for Health and Food Safety
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Hungary: National Institute of Pharmacy
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency
Czech Republic: State Institute for Drug Control

Keywords provided by AOP Orphan Pharmaceuticals AG:
cystic fibrosis
Moli1901
Lancovutide
2622U90
duramycin
lung

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on September 18, 2014