Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01270347
• Date of registration: 03/01/2011
• Prospective Registration: No
• Primary sponsor: Horizon Pharma USA, Inc.
• Public title: Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients TIS
• Scientific title: Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients
• Date of first enrolment: January 2011
• Target sample size: 267
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01270347
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

France, Germany, Ireland, Israel, United Kingdom, United States

Contacts

• Name: Patrick Flume, M.D.
• Affiliation: Medical University of South Carolina

Key inclusion & exclusion criteria

Inclusion Criteria (selected):

- > 12 years of age

- Confirmed Diagnosis of Cystic Fibrosis

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

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

- Have received at least 3 courses of inhaled tobramycin 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 inhaled or systemic aminoglycosides
including tobramycin or any excipients

- Evidence of acute upper within 10 days or lower respiratory infections within 28 days
prior to dosing

- CrCl < 20 at Screening

- History of lung transplantation

Extension Portion of the Study: Patients enrolled in Mpex 209 are permitted to participate
in the open label extension as long as they complete Visit 7 (Day 168), provide informed
consent for participation in the open label extension of in the study and are clinically
stable, as assessed by the Investigator.



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

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: MP-376 (Levofloxacin Solution for Inhalation)

Drug: TIS (Tobramycin Inhalation Solution)

Primary Outcome(s)

Safety [Time Frame: 168 and 336 days]

Efficacy [Time Frame: 28 Days]

Secondary Outcome(s)

Evaluate changes in FEV1 and FVC from Baseline to Day 28 [Time Frame: 28 days]

Changes in bacterial load and susceptability patterns of isolated organisms from Baseline to Day 28 [Time Frame: 28 days]

Changes in respiratory and other domains of CFQ-R from Baseline to Day 28 [Time Frame: 28 days]

Secondary ID(s)

2010-019634-26

Mpex-209

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Forest Laboratories