Cystic Fibrosis (CF)Phase 2NCT00677365
Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients
A Phase 2 study testing MP-376 in people with Cystic Fibrosis (CF), run by Amgen at 50 sites in 3 countries.
Trial summary
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cystic Fibrosis (CF)
- What is being tested?
- MP-376
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 151 participants
- Where
- 50 sitesin 3 countries
- Study dates
- Jun 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- > 16 years of age
- Confirmed Diagnosis of Cystic Fibrosis
- Positive sputum culture for P. aeruginosa within the past 18 months
- Patients are able to elicit a forced expiratory volume in 1 second (FEV1) >/= 25% but </= 85% of predicted value at screening
- Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months
- Clinically stable with no changes in health status within the last 30 days
- Able to reproducibly produce sputum and perform spirometry
Who cannot join
- Use of any nebulized or systemic antibiotics within 30 days prior to baseline
- History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
- Evidence of acute upper within 10 days or lower respiratory infections within 30 days prior to dosing
- Creatine clearance < 50mg/ml, aspartate transaminase (AST), alanine transaminase (ALT) or total bilirubin >/= 3 x upper limit of normal (ULN) at Screening
Trial locations and contacts
50 sites in 3 countries.
50 sites in 3 countries
United States39 sites
Study site
Albany, New York, 12208
Study site
Ann Arbor, Michigan, 48109
Study site
Boston, Massachusetts, 02115
Study site
Charleston, South Carolina, 29425
Study site
Chicago, Illinois, 60025
Study site
Cincinnati, Ohio, 45224
Study site
Columbia, South Carolina, 29203
Study site
Columbus, Ohio, 43205
Study site
Dayton, Ohio, 45404
Study site
Iowa City, Iowa, 52242
Study site
Kalamazoo, Michigan, 49007
Study site
Las Vegas, Nevada, 89107
Study site
Little Rock, Arkansas, 72202
Childrens Hospital
Los Angeles, California, 90027
Study site
Los Angeles, California, 90033
Study site
Louisville, Kentucky, 40202
Study site
Memphis, Tennessee, 38105
Study site
Miami, Florida, 33136
Study site
Minneapolis, Minnesota
Study site
Mobile, Alabama, 36608
Study site
Morristown, New Jersey, 07962
Study site
Oak Lawn, Illinois, 60453
Study site
Oakland, California, 94611
Oklahoma CF Center
Oklahoma City, Oklahoma, 73104
Study site
Oklahoma City, Oklahoma, 73112
Study site
Orange, California, 92868
Study site
Orlando, Florida, 32801
Study site
Palo Alto, California, 94304
Study site
Park Ridge, Illinois, 60068
Study site
Philadelphia, Pennsylvania, 19102
Study site
Phoenix, Arizona, 85016
Study site
Pittsburgh, Pennsylvania, 15213
Study site
Sacramento, California, 95817
Study site
Salt Lake City, Utah, 84132
Study site
San Antonio, Texas, 78212
Study site
San Diego, California, 92103
Study site
Tucson, Arizona, 85724
Study site
Tyler, Texas, 75708
Study site
Valhalla, New York, 10595
Germany8 sites
Study site
Berlin
Study site
Essen
Study site
Frankfurt
Study site
Gerlingen
Study site
Gieben
Study site
Kiel
Study site
München
Study site
Tübingen
Netherlands3 sites
Study site
Amsterdam
Study site
Groesbeek
Study site
Rotterdam
About this study
Official title: Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.
Read the detailed description
This trial will be a double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of levofloxacin administered as MP-376 of three dosage regimens given for 28 days by the aerosol route to CF patients.
Study with completed results acquired from Horizon in 2024.
- Conditions
- Cystic Fibrosis (CF)
- Being tested
- MP-376, Placebo
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MP-376Drug
Also called Levofloxacin Inhalation Solution, Aeroquin
3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days
PlaceboDrug
same frequency as study drug using the same nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo inhaled either once or twice daily via the PARI eFlow nebulizer for 28 days Receives: Drug: Placebo |
| MP-376 120 mg QD | Experimental | MP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days Receives: Drug: MP-376 |
| MP-376 240 mg QD | Experimental | MP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days Receives: Drug: MP-376 |
| MP-376 240 mg BID | Experimental | MP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebulizer for 28 days Receives: Drug: MP-376 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in P. Aeruginosa Density
Patients were required to cough deeply and then spit sputum into a sterile container. The bacteria contained in the sputum sample was incubated in a laboratory and the number of P. aeruginosa colony forming units per gram of sputum (CFU/g) was determined. The difference in CFUs/g were then compared from baseline to the conclusion of the 28 day treatment period
Measured: from baseline to end of treatment (28 days)
Secondary outcomes (5)
Time to Administration of Other Anti-pseudomonal Antimicrobials
Time to administration of other anti-pseudomonal antimicrobials in patients with at least one of the following: decreased exercise tolerance, increased cough, increased sputum/chest congestion, or decreased appetite; 25th percentile data reported
Measured: from baseline until final study visit (up to 56 days)
Percent Change in Forced Expiratory Volume in 1 Second (FEV1)
Percent change in the amount of air the patient could exhale in 1 second
Measured: from baseline to end of the 28-day treatment period (28 days)
Change in FEV1 Percent Predicted
Change in the predicted percent of air the patient could exhale in one second
Measured: from baseline to the end of the treatment 28-day treatment period (28 days)
Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R)
Change in the score from 0 to 100 that a patient reports for their respiratory symptoms in the CFQ-R. An increase in score illustrates an improvement in symptoms. An increase of 4 or more is considered clinically significant
Measured: from baseline to the end of the 28-day treatment period (28 days)
Changes in Susceptability Patterns of Isolated Organisms
All isolates of P. aeruginosa cultures grown from patient sputum samples were evaluated to see whether the minimum concentration of levofloxacin needed to inhibit growth of the bacteria (i.e., minimum inhibitory concentration; MIC) had increased; 2. The MIC50 and MIC90 values were calculated as the 50th percentile value and the 90th percentile value, respectively. Note that percentile values between dilution values were rounded up to the nearest dilution value
Measured: from baseline until the end of the 28-day treatment period (28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- 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
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677365
- Sponsor's protocol ID
- Mpex-204
- Other IDs
- 2008-001728-30, 2008
- Status last verified
- Dec 2024
- First submitted
- 12 May 2008
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Geller DE, Flume PA, Staab D, Fischer R, Loutit JS, Conrad DJ; Mpex 204 Study Group. Levofloxacin inhalation solution (MP-376) in patients with cystic fibrosis with Pseudomonas aeruginosa. Am J Respir Crit Care Med. 2011 Jun 1;183(11):1510-6. doi: 10.1164/rccm.201008-1293OC. Epub 2011 Feb 25.
PubMed 21471106
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients
- ClinicalTrials.gov ID
- NCT00677365
- Acronym / sponsor ID
- Mpex-204
- Conditions
- Cystic Fibrosis (CF)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 May 2008 (estimated)
- Results
- Posted 12 Jun 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.
Detailed description
This trial will be a double-blind, placebo-controlled study to evaluate the safety, tolerability and efficacy of levofloxacin administered as MP-376 of three dosage regimens given for 28 days by the aerosol route to CF patients.
Study with completed results acquired from Horizon in 2024.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo inhaled either once or twice daily via the PARI eFlow nebulizer for 28 days |
| MP-376 120 mg QD | Experimental | Drug: MP-376MP-376 120 mg inhaled Once Daily (QD) via the PARI eFlow nebulizer for 28 days |
| MP-376 240 mg QD | Experimental | Drug: MP-376MP-376 240 mg inhaled QD bia the PARI eFlow nebulizer for 28 days |
| MP-376 240 mg BID | Experimental | Drug: MP-376MP-376 240 mg inhaled twice daily (BID) via the PARI eFlow nebulizer for 28 days |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- > 16 years of age
- Confirmed Diagnosis of Cystic Fibrosis
- Positive sputum culture for P. aeruginosa within the past 18 months
- Patients are able to elicit a forced expiratory volume in 1 second (FEV1) >/= 25% but </= 85% of predicted value at screening
- Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months
Key exclusion criteria (4 listed)
- Use of any nebulized or systemic antibiotics within 30 days prior to baseline
- History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
- Evidence of acute upper within 10 days or lower respiratory infections within 30 days prior to dosing
- Creatine clearance < 50mg/ml, aspartate transaminase (AST), alanine transaminase (ALT) or total bilirubin >/= 3 x upper limit of normal (ULN) at Screening
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 |
|---|---|---|
| MP-376Also: Levofloxacin Inhalation Solution, Aeroquin3 dose regimens of MP-376 administered twice daily (BID) or once daily (QD) for 28 days | Drug | MP-376 120 mg QD, MP-376 240 mg BID, MP-376 240 mg QD |
| Placebosame frequency as study drug using the same nebulizer | Drug | Placebo |
Primary outcome
Change in P. Aeruginosa Density
Time frame: from baseline to end of treatment (28 days)
Patients were required to cough deeply and then spit sputum into a sterile container. The bacteria contained in the sputum sample was incubated in a laboratory and the number of P. aeruginosa colony forming units per gram of sputum (CFU/g) was determined. The difference in CFUs/g were then compared from baseline to the conclusion of the 28 day treatment period
5 secondary outcomes
Time to Administration of Other Anti-pseudomonal Antimicrobials
Time frame: from baseline until final study visit (up to 56 days)
Percent Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: from baseline to end of the 28-day treatment period (28 days)
Change in FEV1 Percent Predicted
Time frame: from baseline to the end of the treatment 28-day treatment period (28 days)
Changes in Respiratory Domain Scores of Cystic Fibrosis Questionnaire - Revised (CFQ-R)
Time frame: from baseline to the end of the 28-day treatment period (28 days)
Changes in Susceptability Patterns of Isolated Organisms
Time frame: from baseline until the end of the 28-day treatment period (28 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 21471106Geller DE, Flume PA, Staab D, Fischer R, Loutit JS, Conrad DJ; Mpex 204 Study Group. Levofloxacin inhalation solution (MP-376) in patients with cystic fibrosis with Pseudomonas aeruginosa. Am J Respir Crit Care Med. 2011 Jun 1;183(11):1510-6. doi: 10.1164/rccm.201008-1293OC. Epub 2011 Feb 25.
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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.
MD study director
Amgen
50 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MP-376 in people with Cystic Fibrosis (CF), run by Amgen at 50 sites in 3 countries.
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 7 inclusion and 4 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 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United States, Germany, Netherlands. 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?
Yes. Results are posted in the registry (first posted 12 Jun 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in P. Aeruginosa Density (time frame: from baseline to end of treatment (28 days)). 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 NCT00677365, which also lists 1 linked publication.
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 Dec 2024.