NCT01769898

The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to examine the efficacy and safety of 24 weeks treatment with theophylline plus low-dose formoterol-budesonide in subjects with bronchiectasis.

Detailed description

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.

Conditions

• Bronchiectasis

Interventions

Type	Name	Description
DRUG	Formoterol-budesonide	Formoterol-budesonide combined treatment (4.5µg/160µg Q12H)
DRUG	Theophylline	Theophylline 0.1 Q12H
DRUG	Placebo	Placebo for theophylline 0.1 Q12H

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-09-01
• Completion: 2014-11-01
• First posted: 2013-01-17
• Last updated: 2015-03-11

Locations

2 sites across 1 country: China