Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis
NCT ID: NCT00671736
Last Updated: 2009-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
160 participants
INTERVENTIONAL
2007-10-31
2009-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
daily inhalation
Moli1901
2,5 ml inhalation solution, 8 weeks treatment period
2
inhalation every other day
Moli1901
2,5 ml inhalation solution, 8 weeks treatment period
3
inhalation twice a week
Moli1901
2,5 ml inhalation solution, 8 weeks treatment period
4
daily inhalation
Moli1901 placebo
2,5 ml placebo solution, 8 weeks treatment period
Interventions
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Moli1901
2,5 ml inhalation solution, 8 weeks treatment period
Moli1901 placebo
2,5 ml placebo solution, 8 weeks treatment period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
ALL
No
Sponsors
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AOP Orphan Pharmaceuticals AG
INDUSTRY
Responsible Party
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AOP Orphan Pharmaceuticals AG
Principal Investigators
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Ernst Eber, Prof Dr
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
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Medical University
Graz, , Austria
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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EudraCT No 2006-006693-24
Identifier Type: -
Identifier Source: secondary_id
Moli1901-010B
Identifier Type: -
Identifier Source: org_study_id