A Phase 2 Study of MP-376 to Prevent Acute Exacerbations in Chronic Obstructive Pulmonary Disease (COPD) Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739648
• Other study ID #: Mpex-302
• Status: Completed
• Phase: Phase 2
• First received: August 20, 2008
• Last updated: January 17, 2018
• Start date: October 2008
• Est. completion date: April 2010

Study information

• Verified date: January 2018
• Source: Horizon Pharma USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• MP-376
MP-376 administered via inhalation for 5 consecutive days within 28-day treatment cycles for up to 12 cycles
• Placebo
same frequency as study drug using the same method of delivery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Horizon Pharma USA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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)