Chronic Obstructive Pulmonary Disease Clinical Trial
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
Verified date | January 2018 |
Source | Horizon Pharma USA, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 322 |
Est. completion date | April 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria (selected): - > 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 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 - Creatinine clearance < 40 mg/ml/min, AST, ALT >/= 5 x upper limit of normal (ULN) or total bilirubin >/= 3 x ULN at Screening |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Horizon Pharma USA, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From randomization to the patients final study visit (up to 12 months) | |
Secondary | 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 | from randomization to the patient's final study visit (up to 12 months) | |
Secondary | Percent Change in Forced Vital Capacity (FVC) | The percent change in the amount of air a patient can inhale | from baseline to the conclusion of the fourth 28-day treatment cycle (4 months) | |
Secondary | 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 | from baseline to the conclusion of the fourth 28-day treatment cycle (4 months) |
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