A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
MP-376 (Levofloxacin solution for Inhalation)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Patients
Eligibility Criteria
Inclusion Criteria (selected):
- >/= 40 years of age
- History of COPD
- FEV1 </= 65% of predicted and FEV1/FVC </= 0.7 value at Screening
- Clinically stable with no changes in health status within the last 30 days
- Lifetime smoking history of at least 15 pack-years
- Willing and able to give informed consent
Exclusion Criteria (selected):
- Use of any systemic or inhaled antibiotics within 30 days prior to baseline
- History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
- CrCl < 50/ml/min, AST, ALT or total bilirubin >/= 3 x ULN at Screening
- Significant or unstable medical conditions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
MP-376 Inhalation Solution
Placebo
Outcomes
Primary Outcome Measures
Evaluate the safety, tolerability and PK of two dosage regimens of MP-376
Secondary Outcome Measures
Full Information
NCT ID
NCT00752414
First Posted
September 11, 2008
Last Updated
January 17, 2018
Sponsor
Horizon Pharma USA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00752414
Brief Title
A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
Phase 1b, Randomized, Single-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MP-376 Inhalation Solution Administered for 5 Days to Chronic Bronchitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Horizon Pharma USA, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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, (the sponsor on record at time of the study's initial registration) 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 1b, multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of MP-376 solution for inhalation given for 5 days to COPD patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Patients
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
MP-376 Inhalation Solution
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
MP-376 (Levofloxacin solution for Inhalation)
Intervention Description
Daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
same frequency as MP-376
Primary Outcome Measure Information:
Title
Evaluate the safety, tolerability and PK of two dosage regimens of MP-376
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (selected):
>/= 40 years of age
History of COPD
FEV1 </= 65% of predicted and FEV1/FVC </= 0.7 value at Screening
Clinically stable with no changes in health status within the last 30 days
Lifetime smoking history of at least 15 pack-years
Willing and able to give informed consent
Exclusion Criteria (selected):
Use of any systemic or inhaled antibiotics within 30 days prior to baseline
History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
CrCl < 50/ml/min, AST, ALT or total bilirubin >/= 3 x ULN at Screening
Significant or unstable medical conditions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Sethi, M.D.
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68154
Country
United States
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Phase 1b Study to Evaluate the Safety and PK of MP-376 in Chronic Obstructive Pulmonary Disease (COPD) Patients
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