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

Guangzhou Medical University

Status and phase: Completed; Phase 4

Conditions: Bronchiectasis

Treatments: Drug: Formoterol-budesonide; Drug: Theophylline; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01769898

theophylline in bronchiectasis

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients between 18-70 years old with non-cystic fibrosis(CF) bronchiectasis, free from acute exacerbations for at least 3 months.Stable phase of the disease.

Exclusion criteria

• Patients with a cigarette smoking history of more than 10 packs-year. Patients with COPD. Patients with traction bronchiectasis due to advanced fibrosis. Patients with known intolerance for theophylline. Patients with asthma. Patients with other disease disturbing outcomes of the trials. Patients without consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Placebo+formoterol-budesonide

Placebo Comparator group

Description:

Placebo(for Theophylline sustained-release tablet) tablet by mouth 100mg every 12hours for 24weeks. Inhaled Formoterol-budesonide combined treatment 4.5µg/160µg every 12hours for 24weeks.

Treatment:

Drug: Placebo

Drug: Formoterol-budesonide

Theophylline+formoterol-budesonide

Experimental group

Description:

Theophylline sustained-release tablet by mouth 100mg every 12hours for 24weeks. Inhaled formoterol-budesonide combined treatment 4.5µg/160µg every 12hours for 24weeks.

Treatment:

Drug: Theophylline

Drug: Formoterol-budesonide