New Phase 3 Trial Tests Therapy For Non-Cystic Fibrosis Bronchiectasis Exacerbations On Patients In China

New Phase 3 Trial Tests Therapy For Non-Cystic Fibrosis Bronchiectasis Exacerbations On Patients In China

OM-85Jinmimg Gao, a Professor of Oncology and Pharmacology in the Department of Pharmacology, Simmons Comprehensive Cancer Center at UT Southwestern Medical Center, is the principal investigator of a Phase-3 clinical trial focused on the “Preventive effect of OM-85 on Bronchiectasis Exacerbation” (iPROBE) in Chinese patients. The study was launched in December 2013 by the Chinese Academy of Medical Sciences (CAMS) with an estimated primary completion date for final data collection of November 2015. Investigators plan on enrolling 250 patients with bronchiectasis who had experienced at least one acute exacerbation in the previous year.

For this clinical trial, Jinming Gao, also a professor Peking Union Medical College Hospital, coordinated research from CAMS, Peking University, Capital Medical University, Tianjin Medical University, Zhejiang University, and China Medical University.

Non-cystic fibrosis bronchiectasis is characterized by the irreversible dilatation of the medium-sized bronchi as a result of airway injury from recurrent or chronic inflammation and lower respiratory tract infections. Bronchiectasis airways are commonly colonized with bacterial species, and it enhances bronchiectasis exacerbations.

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OM-85, an oral immunostimulant, consists of extracts of eight kinds of bacteria that are important in respiratory infections. OM-85 could help to build up resistance against the pathogens in patients and prevent rapid decline in lung function. Previous clinical trials demonstrated that OM-85 reduced the risk of acute exacerbation of chronic obstructive pulmonary disease (COPD).

The study is designed as a randomized, double-blinded, placebo-controlled trial. Patients will receive 1 capsule of 7mg OM-85 or placebo per day for 10 days each month for 3 consecutive months. They will assess the outcomes such as event-based exacerbation, lung function parameters, and total scores judged by the St George’s respiratory questionnaire, Leicester cough questionnaire, and inflammatory index.

For more details of the study: http://www.clinicaltrials.gov/ct2/show/study/NCT01968421?term=iPROBE&rank=1

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