CTBM100G2202, For patients with Non-Cystic Fibrosis Bronchiectasis
Research type
Research Study
Full title
A randomized, blinded, parallel group, multi-center dosefinding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection
IRAS ID
212839
Contact name
Charles Haworth
Contact email
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2015-003040-39
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This is a clinical research study to find out if the drug Tobramycin Inhalation Powder (TIP) is safe and has beneficial effects in treating a lung infection caused by a certain type of bacteria called “ Pseudomonas aeruginosa” (P. aeruginosa) in people with non-cystic fibrosis (non-CF) bronchiectasis.
Over 600 people have been treated with this medicine in clinical studies to date. This medicine has been approved by the European Medicine Agency (EMA), and several other authorities in the world for the treatment of lung infection caused by the bacterium P. aeruginosa in patients with cystic fibrosis 6 years and older and is currently available in the United Kingdom for this condition. However, TIP is not approved for the treatment of people with non-cystic fibrosis bronchiectasis.
This study will evaluate TIP treatment for the treatment of lung infections caused by P. aeruginosa in adult patients with non-CF bronchiectasis as compared to placebo.
About 180 patients will participate in this study from approximately 8 European countries and study participation will last for up to 28 weeks.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
16/EE/0358
Date of REC Opinion
18 Oct 2016
REC opinion
Further Information Favourable Opinion