A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients

• Conditions: Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis; MedDRA version: 9.1Level: LLTClassification code 10011763Term: Cystic fibrosis lung; MedDRA version: 9.1Level: LLTClassification code 10021860Term: Infection pseudomonas aeruginosa

• Registration Number: EUCTR2008-001728-30-DE
• Lead Sponsor: Mpex Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-07
• Last Update Posted: 11 March 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 190

Inclusion Criteria

1. Are at least 16 years of age (at least 18 years of age in Germany and the Netherlands).
2. Have a clinical diagnosis of CF based on the following criteria:
a) positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) and/or
b) a genotype with two identifiable mutations consistent with CF, and
c) accompanied by one or more clinical features consistent with the CF phenotype.
3. Are able to elicit an FEV1 > 25% but < 85% predicted value at screening based on Hankinson/NHanes criteria (reference Hankinson, et. al).
4. Have received at least 3 courses of inhaled antimicrobials over the preceding 12 months and have received at least one course of inhaled tobramycin/TOBI®/colistin in the 2 months prior to Visit 1, but none in the 28 days prior to Visit 1.
5. Must have a sputum specimen at screening positive for P. aeruginosa and have a history of at least one positive sputum culture positive for P. aeruginosa within the last 18 months.
6. Clinically stable with no significant changes in health status within the last 30 days.
7. Are able to perform spirometry reproducibly.
8. Have not smoked tobacco within 30 days prior to Visit 1 and agree not to smoke for the duration of the study.
9. Are able to reproducibly expectorate sputum.
10. Are able to and have given written informed assent/consent in a manner approved by the Institutional Review Board/Ethics Committee and are willing to comply with the requirements of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Have used an investigational agent within 30 days prior to Visit 1.
2. Have used any nebulized or systemic antibiotics active against P. aeruginosa within 30 days prior to Visit 1, other than maintenance oral azithromycin, which must be have been initiated at least 30 days prior to Visit 1.
3. History of hypersensitivity to fluoroquinolones or excipients of MP-376 (magnesium chloride).
4. History of intolerance to bronchodilators or unwilling to use a bronchodilator during the study.
5. Current use of oral corticosteroids in doses exceeding the equivalent of 10 mg prednisone/day or 20 mg prednisone every other day.
6. Changes in physiotherapy technique or schedule within 14 days prior to Visit 1.
7. Changes in medical regimen for treatment of CF (e.g., introduction, dose escalation, or elimination of therapies such as dornase alfa, non-steroidal anti-inflammatory agents, azithromycin, hypertonic saline, or inhaled corticosteroids) within 30 days of Visit 1.
8. History of lung transplantation
9. Evidence of acute upper respiratory tract infection within 10 days or lower respiratory tract infection within 30 days prior to Visit 1
10. Are pregnant, breastfeeding, or unwilling to practice birth control or abstinence during participation in the study (women only).
11. Have a history of seizures or low seizure threshold (e.g., epilepsy).
12. Have renal dysfunction (calculated CrCl < 50ml/min) at Screening.
13. Have AST, ALT or total bilirubin = 3 x upper limit of normal (ULN) at screening or evidence of severe liver disease (e.g., cirrhosis, portal hypertension).
14. Known history of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection/seropositivity. (Based on medical history, screening labs are not required.)
15. Have a history of hemoptysis = 30 mLs over any 24 hour period during the 30 days prior to Visit 1.
16. Have an oxygen saturation < 90% on room air at Screening or Visit 1.
17. Have a > 15% relative decline in FEV1 (L) from Screening to Visit 1.
18. Are a dependent (as an employee or relative) of the sponsor, contract research organization or Investigator.
19. Have a present condition, or abnormality in screening laboratory tests or physical examination findings, that in the opinion of the Investigator or Medical Monitor would compromise the safety of the patient or the quality of the data.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified