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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-11-30

Brief Summary

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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.

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Detailed Description

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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

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Bronchiectasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo+formoterol-budesonide

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.

Group Type PLACEBO_COMPARATOR

Formoterol-budesonide

Intervention Type DRUG

Formoterol-budesonide combined treatment (4.5µg/160µg Q12H)

Placebo

Intervention Type DRUG

Placebo for theophylline 0.1 Q12H

Theophylline+formoterol-budesonide

Theophylline sustained-release tablet by mouth 100mg every 12hours for 24weeks.

Inhaled formoterol-budesonide combined treatment 4.5µg/160µg every 12hours for 24weeks.

Group Type EXPERIMENTAL

Formoterol-budesonide

Intervention Type DRUG

Formoterol-budesonide combined treatment (4.5µg/160µg Q12H)

Theophylline

Intervention Type DRUG

Theophylline 0.1 Q12H

Interventions

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Formoterol-budesonide

Formoterol-budesonide combined treatment (4.5µg/160µg Q12H)

Intervention Type DRUG

Theophylline

Theophylline 0.1 Q12H

Intervention Type DRUG

Placebo

Placebo for theophylline 0.1 Q12H

Intervention Type DRUG

Other Intervention Names

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Symbicort tu rbuhaler Theophylline Sustained-Release Tablet

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No