The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis
Non-cystic fibrosis bronchiectasis is an orphan disease caused by the pathogenic vicious
circle including infection, inflammation and airway repair. Today's principle of treatment
is to break the cycle of inflammation and infection. Nowadays, most clinical trials are
anti-infective treatment by antibiotics trying to break this cycle by reducing the bacterial
load, which may cause bacterial resistance. There were still some anti-inflammation trials
by using inhaled corticosteroids(ICS). Tsang and Martínez-García showed that inhaled
corticosteroids reduced IL-1,IL-8 levels and sputum inflammation cells, and improved sputum
volume as well as quality of life, though the corticosteroid must be high dose or medium
dose combined with long-acting ß2 adrenergic agonists. As described in asthma and chronic
obstructive pulmonary disease(COPD), theophylline can improve the activity of histone
deacetylase (HDAC) and then enhanced the anti-inflammatory effect of steroids. We hypothesis
that theophylline may have the same effect in subjects with bronchiectasis. Theophylline
plus inhaled low-dose formoterol-budesonide may improve quality of life and reduce airway
inflammation.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Quality of Life Assessment with St George's Respiratory Questionnaire(SGRQ) and Leicester Cough Questionnaire(LCQ)
Baseline and 24 weeks
No
Chen Rongchang, Professor
Study Director
institute vice director
China: Ethics Committee
theophylline in bronchiectasis
NCT01769898
July 2013
September 2014
Name | Location |
---|