Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis - Full Text View

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:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

U.S. FDA Resources

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

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:

Sponsor

North American Cystic Fibrosis Conference This link exits the ClinicalTrials.gov site

Publications:

Grasemann H, Stehling F, Brunar H, Widmann R, Laliberte TW, Molina L, Döring G, Ratjen F. Inhalation of Moli1901 in patients with cystic fibrosis. Chest. 2007 May;131(5):1461-6.

Zeitlin PL, Boyle MP, Guggino WB, Molina L. A phase I trial of intranasal Moli1901 for cystic fibrosis. Chest. 2004 Jan;125(1):143-9.

Rickert DE, Dingley K, Ubick E, Dix KJ, Molina L. Determination of the tissue distribution and excretion by accelerator mass spectrometry of the nonadecapeptide 14C-Moli1901 in beagle dogs after intratracheal instillation. Chem Biol Interact. 2005 Jun 30;155(1-2):55-61.

McNulty MJ, Hutabarat RH, Findlay JW, Devereux K, Knick VC, Harvey RJ, Molina L. Pharmacokinetics and tissue distribution of the nonadecapeptide Moli1901 in rats and mice. Xenobiotica. 2003 Feb;33(2):197-210.

Zebedin E, Koenig X, Radenkovic M, Pankevych H, Todt H, Freissmuth M, Hilber K. Effects of duramycin on cardiac voltage-gated ion channels. Naunyn Schmiedebergs Arch Pharmacol. 2008 Mar;377(1):87-100. Epub 2008 Jan 5.

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:

Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases

Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013