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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00671736
• Other study ID #: Moli1901-010B
• Secondary ID: EudraCT No 2006-
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2008
• Last updated: August 26, 2009
• Start date: October 2007
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: AOP Orphan Pharmaceuticals AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food SafetyGermany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesHungary: National Institute of PharmacyItaly: National Monitoring Centre for Clinical Trials - Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSweden: Medical Products AgencyCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Moli1901
2,5 ml inhalation solution, 8 weeks treatment period
• Moli1901 placebo
2,5 ml placebo solution, 8 weeks treatment period

Locations

Country	Name	City	State
Austria	Medical University	Graz

Sponsors (1)

Lead Sponsor	Collaborator
AOP Orphan Pharmaceuticals AG

Country where clinical trial is conducted

Austria, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. doi: 10.1007/s00210-007-0248-5. Epub 2008 Jan 5. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in the percentage of the predicted FEV1 (forced expiratory volume in first second) value		at every study visit	Yes
Secondary	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		every 2 weeks	No

External Links

•   North American Cystic Fibrosis Conference
•   Sponsor