Conditions: Pseudomonas Aeruginosa Cystic Fibrosis
Keywords: Tobramycin Inhalation Powder Cystic fibrosis Lung diseases Anti-Bacterial Agents
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 55
Healthy volunteers: no

Brief summary:
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who had completed their study participation in CTBM100C2303 (all visits) and who were proven infected with Pseudomonas aeruginosa (P. aeruginosa) at enrollment into CTBM100C2303.

Detailed description:

Arms:
arm 1: Participants received 112 mg (four 28 mg capsules) of TIP administered by the T-326 Inhaler, twice a day (b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment (one cycle = 56 days) for up to 3 cycles.

Interventions: intervention 1: Tobramycin inhalation powder
Intervention descriptions: intervention 1: Tobramycin inhalation powder, 112 mg (4 capsules of 28 mg), inhalation capsules, b.i.d.

Protocol document: