Cystic FibrosisPhase 2NCT00671736
Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis
A Phase 2 study testing Moli1901 in people with Cystic Fibrosis, run by AOP Orphan Pharmaceuticals AG at 1 site in Austria.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Moli1901
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteAustria
- Study dates
- Oct 2007to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Moli1901, Moli1901 placebo
- Keywords
- cystic fibrosis, Moli1901, Lancovutide, 2622U90, duramycin, lung
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moli1901Drug
Also called Lancovutide, 2622U90, duramycin
2,5 ml inhalation solution, 8 weeks treatment period
Moli1901 placeboDrug
2,5 ml placebo solution, 8 weeks treatment period
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | daily inhalation Receives: Drug: Moli1901 |
| 2 | Experimental | inhalation every other day Receives: Drug: Moli1901 |
| 3 | Experimental | inhalation twice a week Receives: Drug: Moli1901 |
| 4 | Placebo comparator | daily inhalation Receives: Drug: Moli1901 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the percentage of the predicted FEV1 (forced expiratory volume in first second) value
Measured: 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
Measured: every 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2008 (estimated)
- Study startOct 2007
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AOP Orphan Pharmaceuticals AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ernst Eber, Prof Dr, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00671736
- Sponsor's protocol ID
- Moli1901-010B
- Other IDs
- EudraCT No 2006-006693-24
- Status last verified
- Aug 2009
- First submitted
- 30 Apr 2008
- Last updated
- 27 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17494794Zeitlin 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.
PubMed 14718433Rickert 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.
PubMed 15893299McNulty 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.
PubMed 12623761Zebedin 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.
PubMed 18176799Eber 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.
PubMed 32888826
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00671736
- Acronym / sponsor ID
- Moli1901-010B
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, Moli1901, Lancovutide, 2622U90, duramycin, lung
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- AOP Orphan Pharmaceuticals AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 5 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Moli1901daily inhalation |
| 2 | Experimental | Drug: Moli1901inhalation every other day |
| 3 | Experimental | Drug: Moli1901inhalation twice a week |
| 4 | Placebo comparator | Drug: Moli1901 placebodaily inhalation |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moli1901Also: Lancovutide, 2622U90, duramycin2,5 ml inhalation solution, 8 weeks treatment period | Drug | 1, 2, 3 |
| Moli1901 placebo2,5 ml placebo solution, 8 weeks treatment period | Drug | 4 |
Primary outcome
The change in the percentage of the predicted FEV1 (forced expiratory volume in first second) value
Time frame: at every study visit
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2009.
- Background: PubMed 17494794Grasemann 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.
- Background: PubMed 14718433Zeitlin 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.
- Background: PubMed 15893299Rickert 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.
- Background: PubMed 12623761McNulty 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.
- Background: PubMed 18176799Zebedin 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.
- Derived from this study: PubMed 32888826Eber 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.
- SponsorLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernst Eber, Prof Dr principal investigator
Medical University of Graz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moli1901 in people with Cystic Fibrosis, run by AOP Orphan Pharmaceuticals AG at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the percentage of the predicted FEV1 (forced expiratory volume in first second) value (time frame: at every study visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00671736, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2009.