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Clinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) Bronchiectasis

Phase 4
18 Years
70 Years
Open (Enrolling)

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Trial Information

Clinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) Bronchiectasis

For the reasons of lack of sufficient clinical trial evidences, there are no standard
therapy recommendations for bronchiectasis. Currently the treatments for bronchiectasis are
mostly based on experience gained from the treatment of COPD and cystic fibrosis(CF). The
aims of treatment for bronchiectasis are to improve the health-related quality of life, to
slow down the decrease of lung function, to reduce the exacerbation frequence and the
mortality. The mechanism of treatment are including: treating the underlying disease;
improving drainage of sputum; anti-infection; anti-inflammation; treating airway
obstruction. A review written by Peter J. Barnes describes that as a bronchodilator in COPD,
theophylline may relax human airways smooth muscle, have an anti-inflammation rols, and have
an additional effect on mucociliary clearance. Besides, theophylline can improve the
activity of histone deacetylase, which will reverse the resistant of corticosteroids. We
hypothesis that theophylline will have the same effect in subjects with NCF-bronchiectasis
as in subjects with COPD. Our trial may give an evidence of using theophylline in treatment
of bronchiectasis.

Inclusion Criteria:

- Patients between 18-70 years old with non-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:

Scores of the St.George's Respiratory Questionnaire

Outcome Time Frame:

At 24 weeks

Safety Issue:


Principal Investigator

Chen Rongchang, Professor

Investigator Role:

Study Director

Investigator Affiliation:

institute vice director


China: Ethics Committee

Study ID:




Start Date:

November 2012

Completion Date:

January 2014

Related Keywords:

  • Bronchiectasis
  • Bronchiectasis
  • Theophylline
  • Therapeutic Uses
  • HDAC
  • HAT
  • Random placebo study
  • Bronchiectasis