Phase 3
Completed N=282
Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients
Source: ClinicalTrials.gov NCT01270347 ↗Enrolled (actual)
282
Serious AEs
25.3%
Results posted
May 2024
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 90; 180 participants
◆ Published Evidence
Established
47citations · ~5 / year
Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection.
Summary
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms.
Linked Publications
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Safety and efficacy of prolonged levofloxacin inhalation solution (APT-1026) treatment for cystic fibrosis and chronic Pseudomonas aeruginosa airway infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
90; 180 | — |
| PRIMARY Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (FEV1) |
0.38; 2.24 | 0.1481 |
| SECONDARY Percent Change From Baseline in Average Expired Flow Over the Middle Half of The FVC Maneuver (FEF25-75) |
4.705; 9.673 | 0.0830 |
| SECONDARY Percent Change From Baseline in Forced Vital Capacity (FVC) |
-1.152; 0.417 | 0.0945 |
| SECONDARY Number of Participants in Each Category of Relative Change in Percent Predicted FEV1 |
16; 30; 26; 59; 37; 72 | — |
| SECONDARY Number of Participants in Each Category of Percent Change From Baseline in FEV1 |
13; 9; 31; 48; 37; 103 | — |
| SECONDARY Change From Baseline in Pseudomonas Aeruginosa Sputum Density |
-1.19; -0.75 | 0.0530 |
| SECONDARY Number of Participants in Each Category of Change From Baseline in Pseudomonas Aeruginosa Sputum Density |
20; 32; 17; 36; 34; 61 | — |
| SECONDARY Change From Baseline in the Respiratory Domain of the Cystic Fibrosis Questionnaire Revised (CFQ-R) |
-1.31; 1.88 | 0.0463 sig |
| SECONDARY Number of Participants in Each Category of Change From Baseline in the Respiratory Domain of CFQ-R |
25; 81; 32; 49; 34; 56 | — |
Eligibility 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 </= 85% of predicted value at 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.
Data sourced from ClinicalTrials.gov (NCT01270347) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.