search
Back to results

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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Moli1901
Moli1901 placebo
Sponsored by
AOP Orphan Pharmaceuticals AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, Moli1901, Lancovutide, 2622U90, duramycin, lung

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

4

Arm Description

daily inhalation

inhalation every other day

inhalation twice a week

daily inhalation

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
April 30, 2008
Last Updated
August 26, 2009
Sponsor
AOP Orphan Pharmaceuticals AG
search

1. Study Identification

Unique Protocol Identification Number
NCT00671736
Brief Title
Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AOP Orphan Pharmaceuticals AG

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis, Moli1901, Lancovutide, 2622U90, duramycin, lung

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
daily inhalation
Arm Title
2
Arm Type
Experimental
Arm Description
inhalation every other day
Arm Title
3
Arm Type
Experimental
Arm Description
inhalation twice a week
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
daily inhalation
Intervention Type
Drug
Intervention Name(s)
Moli1901
Other Intervention Name(s)
Lancovutide, 2622U90, duramycin
Intervention Description
2,5 ml inhalation solution, 8 weeks treatment period
Intervention Type
Drug
Intervention Name(s)
Moli1901 placebo
Intervention Description
2,5 ml placebo solution, 8 weeks treatment period
Primary Outcome Measure Information:
Title
The change in the percentage of the predicted FEV1 (forced expiratory volume in first second) value
Time Frame
at every study visit
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ernst Eber, Prof Dr
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University
City
Graz
ZIP/Postal Code
8086
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
17494794
Citation
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.
Results Reference
background
PubMed Identifier
14718433
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. doi: 10.1378/chest.125.1.143.
Results Reference
background
PubMed Identifier
15893299
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. doi: 10.1016/j.cbi.2005.04.002.
Results Reference
background
PubMed Identifier
12623761
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. doi: 10.1080/0049825021000022320.
Results Reference
background
PubMed Identifier
18176799
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.
Results Reference
background
PubMed Identifier
32888826
Citation
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.
Results Reference
derived
Links:
URL
http://www.aoporphan.com/
Description
Sponsor
URL
http://www.nacfconference.org/
Description
North American Cystic Fibrosis Conference

Learn more about this trial

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

We'll reach out to this number within 24 hrs