Conditions: Cystic Fibrosis
Keywords: Tobramycin Inhalation Powder Cystic fibrosis Lung diseases Anti-Bacterial Agents Treatment of infections with P. aeruginosa in cystic fibrosis subjects
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 62
Healthy volunteers: no

Brief summary:
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process

Detailed description:

Arms:
arm 1: Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment. arm 2: Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.), in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).

Interventions: intervention 1: Tobramycin Inhalation Powder intervention 2: Placebo
Intervention descriptions: intervention 1: Tobramycin Inhalation Powder as produced by a modified manufacturing process TIP. TIP was provided in hard capsules each containing 28 mg active ingredient (tobramycin); Capsules were packaged in blister cards and administered by the T-326 Inhaler. intervention 2: Placebo inhalation powder consisting of the excipients used for TIP. Placebo was provided in hard capsules, containing 20 mg placebo powder, which were packaged in blister cards, matching in appearance to TIP. Capsules were administered by the T-326 Inhaler.

Protocol document: