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

NCT00671736 | Completed Phase 2 DMC

• 2 other identifiers: Moli1901-010BEudraCT No 2006-006693-24
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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, the tolerability of Moli1901 shall be investigated.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; Moli1901; Lancovutide; 2622U90; duramycin; lung

Outcome Measures

Primary Outcomes (1)

• The change in the percentage of the predicted FEV1 (forced expiratory volume in first second) value

  at every study visit

Secondary Outcomes (1)

• 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

Study Arms (4)

1

EXPERIMENTAL

daily inhalation

Drug: Moli1901

2

EXPERIMENTAL

inhalation every other day

Drug: Moli1901

3

EXPERIMENTAL

inhalation twice a week

Drug: Moli1901

4

PLACEBO COMPARATOR

daily inhalation

Drug: Moli1901 placebo

Interventions

Moli1901 DRUG

2,5 ml inhalation solution, 8 weeks treatment period

Also known as: Lancovutide, 2622U90, duramycin

1; 2; 3

Moli1901 placebo DRUG

2,5 ml placebo solution, 8 weeks treatment period

4

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AOP Orphan Pharmaceuticals AG: lead

Study Sites (1)

Medical University

Graz, 8086, Austria

Location

Related Publications (6)

• Grasemann H, Stehling F, Brunar H, Widmann R, Laliberte TW, Molina L, Doring G, Ratjen F. Inhalation of Moli1901 in patients with cystic fibrosis. Chest. 2007 May;131(5):1461-6. doi: 10.1378/chest.06-2085.

  PMID: 17494794 BACKGROUND

• 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. doi: 10.1378/chest.125.1.143.

  PMID: 14718433 BACKGROUND

• 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. doi: 10.1016/j.cbi.2005.04.002.

  PMID: 15893299 BACKGROUND

• 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. doi: 10.1080/0049825021000022320.

  PMID: 12623761 BACKGROUND

• 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.

  PMID: 18176799 BACKGROUND

• Eber E, Trawinska-Bartnicka M, Sands D, Bellon G, Mellies U, Bolbas K, Quattrucci S, Mazurek H, Widmann R, Schoergenhofer C, Jilma B, Ratjen F. Aerosolized lancovutide in adolescents (>/=12 years) and adults with cystic fibrosis - a randomized trial. J Cyst Fibros. 2021 Jan;20(1):61-67. doi: 10.1016/j.jcf.2020.08.014. Epub 2020 Sep 1.

  PMID: 32888826 DERIVED

Related Links

• Sponsor

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Moli1901; duramycin

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Ernst Eber, Prof Dr

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 30, 2008
• First Posted: May 5, 2008
• Study Start: October 1, 2007
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: August 27, 2009

Record last verified: 2009-08

Locations

AU (1)