| Clinical trials identifier | NCT01775137 |
|---|---|
| Study codes | CTBM100C2401E1 |
| Study title | A 48 Week Extension to CTBM100C2401, a Single Arm, Open-label, Multicenter, Phase IV Extension Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis Who Completed Participation in CTBM100C2401. |
| Sponsor | Novartis |
| Drug (brand name) | Tobramycin |
| Drug administration | Inhaled powder |
| Eligible CF patients | At least 6 years of age, chronic Pseudomonas aeruginosa lung infection, completed feeder study |
| Controlled study? | No |
| Randomised study? | No |
| Blinded study? | No |
| Extension study? | Yes (feeder study: CTBM100C2401) |
| Study timeframe | The study was conducted between February 2013 and November 2014 |
RESULTS
| What does this mean for me? | When used as a treatment for long term (chronic) Pseudomonas lung infection, tobramycin inhalation powder used twice a day, on a month on-month off basis over 1 year, continues to appear effective and safe. Previous studies have shown it to have similar effectiveness to nebulised tobramycin solution for inhalation for people with chronic Pseudomonas lung infection. |
|---|---|
| Study: | This Phase 4 trial was conducted in 22 sites in 9 countries. |
| Aim: | To assess long term safety of tobramycin inhalation powder (TIP) |
| Participants: | Of 96 participants who completed the feeder study (CTBM100C2401); 45 participants were enrolled in the extension study. There were 6 participants from 3 ECFS-CTN sites in Spain and Italy. |
| Treatment: | As in the feeder study, patients had 56-day treatment cycles with 28 days on TIP, then 28 days of no treatment. During the 28 days on TIP, patients inhaled 112 mg of TIP twice daily. The extension study continued for 6 treatment cycles. All data were analysed from the start of the feeder study to the end of the extension study (12 treatment cycles, 673 days). |
| Safety: | In total, 39 out of the 45 patients enrolled had at least 1 adverse event The most common adverse event, experienced by around half of patients, was infective pulmonary exacerbation of cystic fibrosis. Two patients discontinued the study because of AEs. One patient died during the study (no further information was reported for this patient). 19 patients had a serious adverse event of whom 17 had infective pulmonary exacerbation of cystic fibrosis. |
| Efficacy: | The percent predicted forced expiratory volume in 1 second (ppFEV1) worsened (mean relative decrease of 9.3%) The density of Pseudomonas aeruginosa in sputum decreased slightly: mean (SD) -1.0 (2.70) |
| Data source: | The summary of data provided here is from a registry posting, available here: https://clinicaltrials.gov/ct2/show/results/NCT01775137?sect=X543987016#limit |