Table 5.
Antibiotics research (CFF).
| Antibiotic | Title | Clinical Trial | Study Phase | Results |
|---|---|---|---|---|
| Amikacin liposome inhalation suspension (Arikayce) | Safety/Tolerability Study of Arikayce™ in CF Patients with Chronic Infection Due to Pseudomonas aeruginosa | NCT00558844 | Phase 1 Phase 2 |
Additionally, Liposomal Amikacin was associated with improvement in lung function and reduction in Pseudomonas aeruginosa density. No more frequency of adverse events |
| Study to Evaluate Arikayce™ in CF Patients with Chronic Pseudomonas aeruginosa infection | NCT01315678 | Phase 3 | This study found that the drug Arikayce® was comparable to the approved drug TOBI® (Tobramycin Solution for Inhalation) | |
| Aztreonam for inhalation solution (AZLI) | International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in CF Patients with P. aeruginosa (AIR-CF1). | NCT00112359 | Phase 3 | After 28-days treatment, AZLI improved mean CFQ-R (Cystic Fibrosis Questionnaire-Revised)-Respiratory scores (9.7 points, p < 0.001) compared with placebo. Adverse events for AZLI and placebo were comparable |
| Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in CF Patients with P. Aeruginosa (AIR-CF2) | NCT00104520 | Phase 3 | AZLI also improved mean CFQ-R Respiratory scores (5.01 points, p = 0.02), improved FEV1 (6.3%, p = 0.001), and decreased sputum PA density (−0.66 log10 CFU/gram, p = 0.006) compared with placebo. No difference in adverse events | |
| Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in CF Patients with Pseudomonas aeruginosa (PA) (AIR-CF3) | NCT00128492 | Phase 3 | Patients who received AZLI three times a day had greater improvement in FEV1 and in patient reported outcomes (CFQ-R) | |
| Inhaled levofloxacin (Quinsair TM) | Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in CF Patients (TIS) | NCT01270347 | Phase 3 | Study results showed that levofloxacin was not inferior to inhaled tobramycin as measured by lung function. The adverse event profile was similar for both the inhaled levofloxacin and tobramycin solution for inhalation groups; however, levofloxacin treated participants complained more frequently about the taste of the medication |
| MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients with CF | NCT01180634 | Phase 3 | Inhaled levofloxacin was generally well-tolerated; however, the study did not demonstrate a benefit after 28 days of treatment on reducing or delaying pulmonary exacerbations | |
| Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Paediatric (CF) Patients | NCT00840333 | Phase 1 |
Closed to enrolment No results yet |