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

Phase 4
18 Years
70 Years
Not Enrolling

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Trial Information

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

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Quality of Life Assessment with St George's Respiratory Questionnaire(SGRQ) and Leicester Cough Questionnaire(LCQ)

Outcome Time Frame:

Baseline and 24 weeks

Safety Issue:


Principal Investigator

Chen Rongchang, Professor

Investigator Role:

Study Director

Investigator Affiliation:

institute vice director


China: Ethics Committee

Study ID:

theophylline in bronchiectasis



Start Date:

July 2013

Completion Date:

September 2014

Related Keywords:

  • Bronchiectasis
  • Bronchiectasis
  • Theophylline
  • Therapeutic Uses
  • HDAC
  • HAT
  • Random placebo study
  • ICS(inhaled corticosteroid)
  • corticosteroid
  • Inhaled corticosteroid
  • Bronchiectasis