Chronic Obstructive Pulmonary DiseasePhase 2NCT00739648
A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 2 study testing MP-376 in people with Chronic Obstructive Pulmonary Disease, run by Amgen at 39 sites in United States.
Trial summary
Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- MP-376
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 39 sitesUnited States
- Study dates
- Oct 2008to Apr 2010
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 40 years of age
- History of COPD
- Forced expiratory volume in 1 second (FEV1) </= 70% of predicted and FEV1/Forced vital capacity (FVC) </= 0.7 value at screening
- Have at least two acute exacerbation episodes in the proceeding year
- Clinically stable with no changes in health status within the last 30 days
- Lifetime smoking history of at least 10 pack-years
- Willing and able to use a daily electronic diary
Who cannot join
- Use of any systemic or inhaled antibiotics within 30 days prior to baseline
- History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
- Creatinine clearance < 40 mg/ml/min, AST, ALT >/= 5 x upper limit of normal (ULN) or total bilirubin >/= 3 x ULN at Screening
Trial locations and contacts
39 sites in 1 country.
39 sites in 1 country
United States39 sites
Study site
Buffalo, New York, 14215
Study site
Chula Vista, California, 91911
Study site
Clearwater, Florida, 33765
Study site
Columbus, Ohio, 43210
Study site
DeBary, Florida, 32713
Study site
DeLand, Florida, 32720
Study site
Easley, South Carolina, 29640
Study site
Gaffney, South Carolina, 29340
Study site
Glendale, Arizona, 85306
Study site
Greenville, North Carolina, 27834
Study site
Haleyville, Alabama, 35565
Study site
Hueytown, Alabama, 35023
Study site
Ithaca, New York, 14850
Study site
Johnston, Rhode Island, 02919
Study site
Lomita, California, 90717
Study site
Long Beach, California, 90822
Study site
Maumee, Ohio, 43537
Study site
Medford, Oregon, 97504
Study site
Mission Viejo, California, 92691
Study site
Mobile, Alabama, 36608
Study site
Montgomery, Alabama, 36117
Study site
New Orleans, Louisiana, 70115
Study site
Oceanside, California, 92056
Study site
Omaha, Nebraska, 68198
Study site
Orlando, Florida, 32806
Study site
Palo Alto, California, 94304
Study site
Phoenix, Arizona, 85006
Study site
Richmond, Virginia, 23225
Study site
Riverside, California, 92506
Study site
Salem, Virginia, 24153
Study site
San Antonio, Texas, 78212
Study site
San Diego, California, 92117
Study site
San Jose, California, 95124
Study site
Savannah, Georgia, 31406
Study site
Spartanburg, South Carolina, 29303
Study site
Taylor, Michigan, 48180
Study site
Toledo, Ohio, 43614
Study site
Union, South Carolina, 29379
Study site
Wheat Ridge, Colorado, 80033
About this study
Official title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of MP-376 Inhalation Solution Administered for 5 Days Every 28 Days to Prevent Acute Exacerbations in High Risk COPD Patients
Patients with Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of life. Bacteria appear to have an important role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In addition, recent studies indicate that acquisition of a new strain of H. influenzae, M. catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations. Chronic inflammation and bacterial infection predispose many patients to frequent and recurrent acute exacerbations.
Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will decrease the incidence of acute exacerbations by both by lowering the organism burden, and resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.
Read the detailed description
This study will be a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of MP-376 inhalation solution given daily for 5 days in a 28 day treatment cycle to COPD patients.
Study with completed results acquired from Horizon in 2024.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- MP-376, Placebo
- Keywords
- COPD, Patients
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
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
MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles
PlaceboDrug
Also called MP-376 color-matched placebo
same frequency as study drug using the same method of delivery
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles Receives: Drug: Placebo |
| MP-376 240 mg Twice Daily (BID) | Experimental | MP-376 240 mg BID inhaled via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles Receives: Drug: MP-376 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exacerbation Rate
The number of acute exacerbations per patient-year of study participation, where an acute exacerbation was defined as a deterioration in respiratory symptoms that required treatment with antibiotics, corticosteroids, hospitalization or a combination of those treatments.
Measured: From randomization to the patients final study visit (up to 12 months)
Secondary outcomes (3)
Duration of Acute Exacerbation
From the beginning of antibiotics and/or systemic corticosteroids to the end of antibiotics and/or systemic corticosteroids, whichever was longer, for treatment of the first acute exacerbation
Measured: from randomization to the patient's final study visit (up to 12 months)
Percent Change in Forced Vital Capacity (FVC)
The percent change in the amount of air a patient can inhale
Measured: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)
Percent Change in Forced Expiratory Volume in 1 Second (FEV1)
The percent change in the amount of air a patient can exhale in 1 second
Measured: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startOct 2008
- Primary completionJan 2010
- Study completionApr 2010
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 (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- 322 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
- NCT00739648
- Sponsor's protocol ID
- Mpex-302
- Status last verified
- Dec 2024
- First submitted
- 20 Aug 2008
- Last updated
- 27 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Leidy NK, Murray LT, Monz BU, Nelsen L, Goldman M, Jones PW, Dansie EJ, Sethi S. Measuring respiratory symptoms of COPD: performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials. Respir Res. 2014 Oct 7;15(1):124. doi: 10.1186/s12931-014-0124-z.
PubMed 25287629Leidy NK, Murray LT, Jones P, Sethi S. Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Mar;11(3):316-25. doi: 10.1513/AnnalsATS.201309-305OC.
PubMed 24432712
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 2, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of MP-376 Inhalation Solution Administered for 5 Days Every 28 Days to Prevent Acute Exacerbations in High Risk COPD Patients
- ClinicalTrials.gov ID
- NCT00739648
- Acronym / sponsor ID
- Mpex-302
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, Patients
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Posted 2 Mar 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 Chronic Obstructive Pulmonary Disease (COPD) suffer from frequent and recurrent acute exacerbations (AECB) which are associated with enormous healthcare expenditures and significant morbidity, specifically an increased risk of death, a decline in pulmonary function and a significant change in quality of life. Bacteria appear to have an important role in acute exacerbations in chronic bronchitis and COPD. Studies of acute exacerbations in COPD have shown a reduction in bacterial load with prolonged exacerbation-free interval. In addition, recent studies indicate that acquisition of a new strain of H. influenzae, M. catarrhalis, S. pneumoniae or P. aeruginosa are responsible for many of these exacerbations. Chronic inflammation and bacterial infection predispose many patients to frequent and recurrent acute exacerbations.
Mpex believes that intermittent administration of inhaled MP-376 in high risk patients will decrease the incidence of acute exacerbations by both by lowering the organism burden, and resultant inflammation, as well as pre-emptive eradication of any newly acquired bacterial strains.
Detailed description
This study will be a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of MP-376 inhalation solution given daily for 5 days in a 28 day treatment cycle to COPD 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo inhaled twice daily via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles |
| MP-376 240 mg Twice Daily (BID) | Experimental | Drug: MP-376MP-376 240 mg BID inhaled via the PARI eFlow nebulizer for 5 consecutive days within a 28-day treatment cycle for up to 12 cycles |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- > 40 years of age
- History of COPD
- Forced expiratory volume in 1 second (FEV1) </= 70% of predicted and FEV1/Forced vital capacity (FVC) </= 0.7 value at screening
- Have at least two acute exacerbation episodes in the proceeding year
- Clinically stable with no changes in health status within the last 30 days
Key exclusion criteria (3 listed)
- Use of any systemic or inhaled antibiotics within 30 days prior to baseline
- History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
- Creatinine clearance < 40 mg/ml/min, AST, ALT >/= 5 x upper limit of normal (ULN) or total bilirubin >/= 3 x 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, AeroquinMP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles | Drug | MP-376 240 mg Twice Daily (BID) |
| PlaceboAlso: MP-376 color-matched placebosame frequency as study drug using the same method of delivery | Drug | Placebo |
Primary outcome
Exacerbation Rate
Time frame: From randomization to the patients final study visit (up to 12 months)
The number of acute exacerbations per patient-year of study participation, where an acute exacerbation was defined as a deterioration in respiratory symptoms that required treatment with antibiotics, corticosteroids, hospitalization or a combination of those treatments.
3 secondary outcomes
Duration of Acute Exacerbation
Time frame: from randomization to the patient's final study visit (up to 12 months)
Percent Change in Forced Vital Capacity (FVC)
Time frame: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)
Percent Change in Forced Expiratory Volume in 1 Second (FEV1)
Time frame: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)
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 25287629Leidy NK, Murray LT, Monz BU, Nelsen L, Goldman M, Jones PW, Dansie EJ, Sethi S. Measuring respiratory symptoms of COPD: performance of the EXACT- Respiratory Symptoms Tool (E-RS) in three clinical trials. Respir Res. 2014 Oct 7;15(1):124. doi: 10.1186/s12931-014-0124-z.
- Derived from this study: PubMed 24432712Leidy NK, Murray LT, Jones P, Sethi S. Performance of the EXAcerbations of chronic pulmonary disease tool patient-reported outcome measure in three clinical trials of chronic obstructive pulmonary disease. Ann Am Thorac Soc. 2014 Mar;11(3):316-25. doi: 10.1513/AnnalsATS.201309-305OC.
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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
39 sites in 1 country: 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 Chronic Obstructive Pulmonary Disease, run by Amgen at 39 sites in United States.
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 3 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 39 sites in United States. 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 2 Mar 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?
Exacerbation Rate (time frame: From randomization to the patients final study visit (up to 12 months)). 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 NCT00739648, which also lists 2 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 Dec 2024.