Phase 3 study in patients with lung infections - protocol INS-212
Research type
Research Study
Full title
A Randomized, Open Label, Multicenter Study of Liposomal Amikacin for Inhalation (LAI) in Adult Patients with Nontuberculous Mycobacterial (NTM) Lung Infections caused by Mycobacterium avium complex (MAC) that are refractory to treatment.
IRAS ID
170557
Contact name
Charles Haworth
Contact email
Sponsor organisation
Insmed Inc.
Eudract number
2014-005010-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
This study is a global study to be conducted in hospitals in USA, Europe and Asia Pacific, including patients with lung infections of the Nontuberculous Mycobacterium form. The study drug has been shown in earlier studies to be effective in treating infections; in this study a more direct and sustained delivery into the lungs is hoped to improve response to the infections, using a marketed inhaler and novel format of the drug. Around 350 patients will be treated with the new formulation and a standard drug treatment or just standard drug treatment. They will visit their hospital monthly for 6 months and then every 2 months for a further year. At these visits, health progress checks will be made in the form of blood pressure measurements, ability to walk a set distance, testing of the mucous coughed up during infection and blood samples taken to investigate general health markers. Chest scans may be reviewed and ECGs will be taken at start and end of study.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
15/EE/0130
Date of REC Opinion
30 Apr 2015
REC opinion
Further Information Favourable Opinion