Clinical trial NCT00739648: A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Patients
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2008-08-22
Enrollment: 322
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Exacerbation Rate
timeFrame: From randomization to the patients final study visit (up to 12 months)
Secondary outcomes:
measure: Duration of Acute Exacerbation
timeFrame: from randomization to the patient's final study visit (up to 12 months)
measure: Percent Change in Forced Vital Capacity (FVC)
timeFrame: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)
measure: Percent Change in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: from baseline to the conclusion of the fourth 28-day treatment cycle (4 months)
Other outcomes:
Locations:
city: Haleyville
country: United States
state: Alabama
city: Hueytown
country: United States
state: Alabama
city: Mobile
country: United States
state: Alabama
city: Montgomery
country: United States
state: Alabama
city: Glendale
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Chula Vista
country: United States
state: California
city: Lomita
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Mission Viejo
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Palo Alto
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Jose
country: United States
state: California
city: Wheat Ridge
country: United States
state: Colorado
city: Clearwater
country: United States
state: Florida
city: DeBary
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Savannah
country: United States
state: Georgia
city: New Orleans
country: United States
state: Louisiana
city: Taylor
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Buffalo
country: United States
state: New York
city: Ithaca
country: United States
state: New York
city: Greenville
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Maumee
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Johnston
country: United States
state: Rhode Island
city: Easley
country: United States
state: South Carolina
city: Gaffney
country: United States
state: South Carolina
city: Spartanburg
country: United States
state: South Carolina
city: Union
country: United States
state: South Carolina
city: San Antonio
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
city: Salem
country: United States
state: Virginia
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Leidy 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.