MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 6 January 2025
• Main ID: NCT01180634
• Date of registration: 10/08/2010
• Prospective Registration: Yes
• Primary sponsor: Amgen
• Public title: MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis
• Scientific title: A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients
• Date of first enrolment: November 4, 2010
• Target sample size: 330
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT01180634
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Canada, Israel, New Zealand, United States

Contacts

• Name: MD
• Affiliation: Amgen

Key inclusion & exclusion criteria

Inclusion Criteria (selected):

- >/= 12 years of age

- Confirmed Diagnosis of Cystic Fibrosis

- Positive sputum culture for P. aeruginosa at screening and within the past 12 months

- Patients are able to elicit an FEV1 >/= 25% but screening

- Have received at least 3 courses of inhaled antimicrobials over the preceding 12
months

- Clinically stable with no changes in health status within the last 28 days

- Able to reproducibly produce sputum and perform spirometry

Exclusion Criteria (selected):

- Use of any nebulized or systemic antibiotics within 28 days prior to baseline

- History of hypersensitivity to fluoroquinolones or intolerance with aerosol
medication

- Evidence of respiratory infections within 14 days prior to dosing

- CrCl < 20ml/min or < 20ml/min/1.73 m2 at Screening


Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Aeroquin

Drug: Placebo

Primary Outcome(s)

Time to an Exacerbation [Time Frame: Baseline to end of study (up to 59 days)]

Secondary Outcome(s)

Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R) [Time Frame: Baseline, Day 28]

Absolute Change in Percent Predicted Forced Expiratory Volume in One Second (FEV1) [Time Frame: Baseline, day 28]

Number of Participants With Treatment Emergent Adverse Events [Time Frame: From start of study until end of study (Up to 59 days)]

Time to Administration of Other Systemic and/or Inhaled Antipseudomonal Antimicrobials [Time Frame: Baseline to end of study (up to 59 days)]

Relative Change From Baseline in Percent Predicted FEV1 [Time Frame: Baseline, Day 28]

Time to First Hospitalization [Time Frame: Baseline to end of study (up to 59 days)]

Change From Baseline in Pseudomonas Aeruginosa Sputum Density [Time Frame: Baseline, Day 28]

Secondary ID(s)

2010-019515-38

Mpex-207

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Forest Laboratories

Results

• Results available: Yes
• Date Posted: 30/04/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01180634