The ECFS-CTN cannot guarantee that the information provided here is comprehensive. Please go to the ClinicalTrials.gov link for detailed and up-to-date information on study background, eligibility criteria, study design, outcome measures, study status, participating sites, sponsor contact information and timelines.
You can also contact the CTN coordinating centre for additional information: ECFS-CTN@uzleuven.be (link sends e-mail)
| Study Name on ClinicalTrials.gov (link is external) | Study to Evaluate ArikaceTM in CF Patients With Chronic Pseudomonas Aeruginosa Infections |
|---|---|
| Study Drug | ArikaceTM (Liposomal amikacin for inhalation) |
| Type of Study Drug | Anti-infective |
| Study Title | Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of ArikaceTM in Cystic Fibrosis Patients With Chronic Infection Due to Pseaudomonas Aeruginosa |
| Study Phase | 3 |
| Study Sponsor | Insmed |
http://clinicaltrials.gov/ct2/show/NCT01315678 (link is external) | |
| Participating ECFS-CTN sites | Denmark: Copenhagen France: Nancy, Lyon, Montpellier, West-Paris Germany: Berlin, Frankfurt, Hannover Italy: Genoa, Milan, Verona Spain: Barcelona Sweden: Gothenburg The Netherlands: Utrecht UK: London, Birmingham, Leeds, Nottingham |
| Age | 6 years and older |
Study Results:
Insmed : Arikace™ phase 3 study results
The phase 3 trial (NCT01315678) "randomized, open-Label, active-Controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in cystic fibrosis patients with chronic infection due to Pseudomonas aeruginosa" was conducted in 70 sites in Europe and Canada. Three hundred and two CF patients (? 6 years-old) with chronic Pseudomonas aeruginosa were enrolled to assess the efficacy and safety of Arikace™ (once-daily via an investigational eFlow® Nebulizer System), compared to Tobi® (BID via the PARI LC Plus® Nebulizer System) over a 24-week treatment period with 3 cycles (28-days on/28-days off). The results showed that the first endpoint was met since there was less than a 5%-difference in relative change in lung function as measured by forced expiratory function at 1 s (FEV1, % predicted) after three treatment cycles between both treatment arms. No statistical difference existed between groups for relative changes in FEV1 at other time points, time to and number of pulmonary exacerbations, time to antibiotic rescue treatment, change in density of Pseudomonas aeruginosa in sputum, respiratory hospitalizations and changes in Patient Reported Outcomes assessing Quality of Life. The overall incidence of adverse events was similar in both groups. These data suggest that Arikace™ has a similar therapeutic effect as Tobi® over 3 treatment cycles.
20 ECFS-CTN sites in Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden and UK participated in this study and enrolled 64 of the 302 patients.
The summary of data provided here are from a sponsor press release (July 1, 2013)