Conditions: Pulmonary Infections Pseudomonas Aeruginosa
Keywords: Tobramycin Inhalation Powder Cystic fibrosis Lung diseases Anti-Bacterial Agents Treatment of pulmonary infections with P. aeruginosa in cystic fibrosis participants
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 49
Healthy volunteers: no

Brief summary:
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.

Detailed description:

Arms:
arm 1: Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.

Interventions: intervention 1: Tobramycin inhalation powder
Intervention descriptions: intervention 1: Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler.

Protocol document: